StandardThe

New Herbal Medicines Compendium Offers Free Standards for the Quality of Herbal Ingredients Used in Traditional Medicines

In This Issue CEO Column Science and Standards Global Health Impact Programs Inside USP

With herbal medicines relied upon by consumers worldwide, USP unveiled a new online resource this Spring to provide freely available public standards

to help ensure the quality of the herbal ingredients used in these products. While this new resource— the Herbal Medicines Compendium (HMC)—will provide standards for herbal articles, it will not include standards for ingredients of animal origin, synthetic chemicals or biotechnology-derived medicines. USP launched the compendium on May 20, 2013, with proposed standards for 23 herbal ingredients posted for comment by interested stakeholders worldwide.

USP’s standards for pharmaceuticals are contained in the USP–NF and the Medicines Compendium, USP’s first free, online compendium. Through the new HMC, USP now has a forum for advancing standards for herbal ingredients used in herbal medicines worldwide.

“USP believes that public standards are critically important to help ensure the quality of all medicines, including herbal medicines,” said Dr. Roger L. Williams, chief executive officer of USP. “Through the Herbal Medicines Compendium, we will now have the ability to bet-ter meet the needs of our worldwide stakeholders who seek public standards for herbal medicinal ingredients.”

“With herbal medicines increasingly crossing borders, it is impor-tant to consider the need for global public standards,” said Dr. Dennis Gorecki, chair of USP’s Dietary Supplements and Herbal Medicines Expert Committee. “Standards such as those in the Herbal Medicines Compendium may be used by regulators and other stakeholders in many countries as a tool against adulterated or poor-quality herbal medicines, which are a growing problem. These standards will advance modern analytical techniques necessary to deal with the scientific complexities associated with plant-based ingredients.”

HMC monographs provide tests, procedures and acceptance criteria, with validated analytical procedures and allied reference materials that aid in conformity assessment. HMC monographs and associated general chapters can help ingredient manufactur-

ers, herbal product manufacturers, regulatory agencies and other stakeholders to assess conformance of herbal medicinal ingredients with independent public standards and control the quality of articles moving in international commerce. When coupled with sound regis-tration processes and adherence to Good Manufacturing Practices, standards in HMC can become an important part of the safety net that helps ensure access to good quality medicines.

Robust, Public Standards-Setting ProcessHMC standards are developed through a public standards-setting process that invites input from all interested parties, and with the collaboration and approval of experts from around the world, via the volunteers who serve on the USP Council of Experts and the expert bodies dedicated to HMC. Proposed monographs on the HMC website (http://hmc.usp.org) are initially posted as “For Develop-ment,” which indicates more information is needed before they can advance to the next stage. Once all the information is complete, monographs are advanced for public comment as “For Comment” monographs. After addressing public comments, the standards are authorized by the USP Council of Experts and published as “Final Authorized.”

Continued on page 15. See Herbal Medicines Compendium

Vol. 11 | Issue 1 | Summer 2013

In This Issue Upcoming EventsCEO Column

3 Message from the CEO Revolutionary Approaches to Consistency in Medicines

Science and Standards

4 USP Increases Global Laboratory Capabilities

5 USP Advancing New Approach to Good Distribution Practices in Global Manufacturing Environment

5 Maryland Board of Pharmacy Trained on <797>

6 New Monograph, Reference Standard for Filgrastim Become Official This Year

6 USP, ChP and DIA Co-Host Science & Standards Symposium in Baltimore

7 Proposed USP General Chapter Focuses on Recombinant Monoclonal Antibodies

7 FDA, USP Agreement to Produce Safety and Quality Data for Botanicals

8 China Lab Is First Satellite Site for USP Spectral Library Network

9 USP Hosts Food and Dietary Supplement Adulteration Workshops

9 USP’s Science and Standards Symposia Engage Stakeholders Around the World

Global Health Impact Programs

10 Center for Pharmaceutical Advancement and Training Opens in Ghana

11 PQM Study of Maternal Health Care Products in Ghana Finds Many Counterfeit and Substandard Medicines

11 Indonesian Manufacturers Seek PQM Assistance to Participate in WHO Prequalification Programme

12 USP to Assist FDA in Testing New Counterfeit Detection Device

Inside USP

13 Mid-Cycle Meeting Begins USP’s Preparation for the Future

14 New Logo for USP Evokes Global Health Mission

WORkSHOPS

USP Headquarters – Rockville, MD

4 Economically-Motivated Adulteration of Food Ingredients and Dietary Supplements Co-sponsored by: USP, IFT, NPA and UNPA September 26–27, 2013

4 Ophthalmic Preparations October 21–22, 2013

4 Cell- and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays November 7–8, 2013

4 Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables Co-sponsored by: USP and PQRI December 9–10, 2013

SyMPOSIa

São Paulo, Brazil

4 Science & Standards Symposium July 25–26, 2013

Baltimore, MD

4 Science & Standards Symposium September 18–19, 2013

Visit www.usp.org/meetings-courses/calendar for more information on these events.

Message from the CEO Roger L. Williams, M.D.

usp.org | 3

As I enter the final year of my tenure at USP, I want to share some “revolutionary” approaches that could change the way we

regulate and control medicine.

The elusive goal of consistency in the quality and performance of a medicine over many years, first with a single and then mul-tiple manufacturers, has been stated clearly and often. Advancing science has provided remarkable analytical capabilities as well as theoretical constructs, so we can now imag-ine private and public standards that work toward the goal of consistency more directly and simply than previously imagined.

The coupling of the Reference Procedure-based Monograph (RPM) with studies that ensure Optimal Bioavailability (OBA) results in testing standards (RPM/OBA) that sup-port continuing equivalence in the quality and performance attributes of a medicine relative to the clinical trial material on which safety and efficacy data were originally based. The focus of this approach is on chemical medicines and their ingredients. Adherence to these standards, and to cur-rent Good Manufacturing Practices (cGMP) process/quality standards, over many years of manufacture by a single and then multiple manufacturers support continuing equiva-lence in quality and performance across all products, one to another, and within each product, irrespective of minor changes in manufacturing methods, components and composition. Only simple re-characterization studies would be needed for the drug sub-stance and/or product in the event of more important changes.

An RPM standard may require a very high level of analytical capability to look across representative samples from multiple manufacturers. These requirements can be reduced for a single manufacturer via an Acceptable Procedure (a procedure opti-mized for a specific product). The need for costly quality by design approaches is re-duced or eliminated, as would be the need for intensive regulatory filings and review. No in vivo bioavailability or bioequivalence studies are required if the product meets certain stipulations of the biopharmaceuti-

Revolutionary Approaches to Consistency in Medicines

The overall approach

offers remarkable

opportunities to create

a global system of

interchangeable medicines

that are safe, effective

and high quality, using

low-cost processes and

product testing standards.

Roger L. Williams, Chief Executive Officer, USP

cal classification system. The approach is applicable to perhaps as many as 60 percent of legally marketed medicines—those where the drug substance is deemed highly soluble and which then are formulated in rapidly dissolving dosage forms. Needed studies, either for re-characterization or release of product into a market, are readily performed by a first party (manufacturer), with results maintained for second- (buyer) or third-party (regulator) inspections. RPM/OBA standards can readily be developed by public parties, e.g., regulatory agencies and pharmacopoeias, without the need for dona-tion of information and materials by one or more manufacturers. RPM/OBA standards are fully harmonized at inception and there-after, and can be used throughout the world for testing purposes.

Use of RPM/OBA standards also supports more intensive testing by third parties for falsified and substandard medicines. When coupled with modern spectral library approaches, which rely increasingly on so-phisticated hand-held instruments, the way is paved for rapid field testing and follow-on testing of suspect medicines and their ingredients in official laboratories. Spectral imaging itself might be seen as an exten-sion of identity testing, which already relies typically on infrared procedures.

The overall approach offers remarkable opportunities to create a global system of interchangeable medicines that are safe, effective and high quality, using low-cost processes and product testing standards. This approach might be considered “disruptive” in character, with the capac-ity for great savings in manufacturing and regulatory resources. For products meeting Biopharmaceutics Classification System stipulations, there may not be a need for a reference product (reference listed drug). Each product that is rapidly dissolving, where the drug substance is highly soluble, is as good as it can be—and needs no com-parative data. The approach is particularly applicable to developing countries where regulatory and manufacturing resources are constrained and the possibility of falsified and substandard drugs is high. g

| The Standard4

Science and Standards

USP Increases Global Laboratory Capabilities

During the past two years, USP has focused on increasing laboratory capabilities at its sites in India, China and Brazil to keep up with the growing demand to provide trusted standards that contribute to improved health. While all

USP laboratories focus on procedures development and reference standards testing to support the development of USP monographs and reference standards, each site is also dedicated to unique work that sets it apart from the others.

In 2013, USP’s headquarters in Rock-ville expanded its R&D laboratories to support procedure development for and modernization of USP’s monographs and general chapters for USP–NF, the Food Chemicals Codex (FCC) and the Dietary Supplements Compendium (DSC). USP–Rockville is also the center of the organization’s Reference Standard development and production capabilities. The U.S. laboratories support analytical capabilities in spectrometry, separation science, dosage form performance and biologics, and apply these capabilities to chemical medicines, biological medicines, excipients, food ingredients and dietary supplements compendial standards. Specific laboratory work at USP–Rockville includes high-resolution mass spectro-metric and NMR analysis, characteriza-tion of low-level impurities in complex mixtures, protein sequencing capabilities, and quality control methods for protein therapeutics, to cite a few areas.

USP–India laboratories in Hyderabad feature state-of-the-art R&D chemical, biological and microbiological laboratories that are dedicated to collaborative testing of USP Reference Standards and analytical procedure development in support of standards for chemical and biological medicines. USP–India’s 2011 expansion allowed USP to launch its Medicines Compendium (MC)—an au-thoritative collection of public standards for chemical and biological medicines that are marketed globally. USP–India also has synthetic chemistry capabilities, allowing it to synthesize impurity reference materials, as well as laboratory support for USP–NF monograph modernization.

USP–China, in Shanghai, is undergoing a major expansion, increasing its total area to 95,000 square feet, almost three times its existing size. Operations are expected to commence in the fall of 2013. The additional activities of USP–China will complement those of USP–India and also will include efforts related to excipients, foods, dietary supplements and herbal medicines. USP–China will be the main support hub for the newly launched Herbal Medicines Com-

pendium—a freely available, online resource that provides standards for herbal ingredients used in botanical medicines marketed around the world. (See article on page 1.)

USP–Brazil, in São Paulo, has been steadily expanding for the past three years. The total site area is now 18,000 square feet, and in addition to conducting laboratory testing activities to support USP Reference Standards development, it is now engaged in monograph

USP laboratories around the world are keeping pace with modern laboratory methods and guidelines that help guarantee access to good quality medicines.

modernization activities. The site also has established a group of scientists dedicated to MC procedure development activities.

As USP evolves into a truly global leader in standards-setting science, its laboratories around the world are keeping pace with modern laboratory methods and guidelines to reflect the demands of industry, marketplace and patient communities for robust compendial procedures and reliable reference materials that help guarantee access to good quality medicines. g

The USP–Brazil laboratory.

usp.org | 5

USP advancing New approach to Good Distribution Practices in Global Manufacturing Environment

In today’s pharmaceutical, medical device and dietary supple-ment industries, ingredients are sourced (and products manu-factured) globally. This creates complexity and requires many different organizations and individuals to handle, store, and

distribute everything from raw materials to intermediaries to final products. Because of the breadth of this undertaking and the impor-tance of these products, it is critical to have adequate controls over the entire distribution chain. To help ensure and maintain the original quality of materials or products, each activity should be carried out ac-cording to the principles of good distribution practices. Given current manufacturing realities and to improve the utility of its own standards, USP is proposing a new path forward for good distribution practices.

In 1995, USP membership passed a resolution encouraging the organization to become involved in this area. As a result, USP published its first general chapter on good distribution practices in 1999: <1186> Shipping and Storage of Labile Preparations. Cur-rently, three additional general chapters provide recommendations for activities and practices that can help ensure good trade, storage and distribution of pharmaceutical materials and products: <1079> Good Storage and Shipping Practices (currently official in USP–NF), <1083> Good Distribution Practices—Supply Chain Integrity (published in Pharmacopeial Forum (PF) 38(2) in March 2012) and <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients (currently official in USP–NF).

After a 2012 review of the USP general chapters by the Packaging, Storage, and Distribution, Physical Analysis, and Compounding Expert Committees, a new approach, detailed in a Stimuli article in PF 39 (4) [July-August 2013], was developed. The proposal is to create a series of new informational general chapters that will cover material flow throughout the supply chain. The general chapters will address four main topics, highlighting best practices and principles:

• QualityManagementSystem—Topics will include documen-tation control and resources management; nonconformances, complaints, and corrective actions; and continuous improvement.

• EnvironmentalControlManagement—Topics include building/facility (storage) and transportation vehicles (shipping).

• GoodImportationandExportationPractices—Topics include audits and supply agreements; container seals, cargo inspection, customs and brokers; and verifying product and firm compliance with regulations.

• SupplyChainIntegrityandSecurity—Topics include adultera-tion and counterfeiting; diversion and theft; and product recall procedures.

USP also plans to develop informational general chapters covering specific product types of materials (e.g., special handling consider-ations for radiopharmaceuticals). These may be necessary because the core general chapters are generalized and may omit important factors for certain classes of products or materials.

As an additional and related resource, USP is developing a “good distribution practices” website that lists, as references, global regulations and guidances. USP compiled a repository of references and documents as it began work on these general chapters, and the organization believes it may be a valuable resource for USP stakeholders to stay abreast of how the good distribution practices landscape is evolving globally.

To read the full Stimuli article and to comment, visit www.usp.org/usp-nf/pharmacopeial-forum. g

Maryland Board of Pharmacy Trained on <797>

At the request of the Maryland Board of Pharmacy, USP devel-oped a training course that was presented by Compounding

Expert Committee member, Ms. Patricia Kienle, to the Maryland Board of Pharmacy inspectors on General Chapter <797> Phar-maceutical Compounding—Sterile Prepa-rations. The one-day training, which took place on March 26, 2013, in Baltimore, was the first of its kind and offered inspectors

an in-depth, interactive course on General Chapter <797> focusing on microbial con-tamination risk levels, facilities personnel and monitoring.

Maryland is one of the states that has fully adopted General Chapter <797>, which means that all sterile compounding practitio-ners and facilities in the state must conform to the standards in the general chapter. General Chapter <797> was first made

official in USP–NF in 2004, was updated in 2008, and currently is under revision again.

Based on the success of the training, USP is currently exploring opportunities through the USP Global Education Training program to offer the course in a variety of locations including regionalized trainings, trainings at individual boards of pharmacies and train-ings at USP headquarters. g

| The Standard6

Science and Standards

New Monograph, Reference Standard for Filgrastim Become Official This year

In the Second Supplement to USP 36– NF 31, USP published a monograph for the recombinant biotherapeutic product, filgrastim, which is scheduled

to become official December 1, 2013. Filgrastim is the nonproprietary name given by USP to articles that satisfy the Identity test in this monograph. Used to help fight off infections in immune-compromised patients, filgrastim is widely used among patients undergoing chemotherapy and bone marrow transplants. Now that filgras-tim is approaching the end of its patent expiry, it is attracting the interest of many manufacturers, and a public quality standard will become an important resource to stake-holders worldwide.

Since first introduced for therapeutic use, filgrastim has revolutionized treatment for cancer patients. Filgrastim works by stimulating bone marrow to increase its production of white blood cells. In individuals receiving chemotherapy, white blood cell

USP, ChP and DIa Co-Host Science & Standards Symposium in BaltimoreOn September 18–19, 2013, USP and the Chinese Pharmacopoeia (ChP) will co-host the 10th Annual USP Science & Standards Sym-posium in Baltimore, Md., in partnership with the Drug Information Association (DIA). The symposium will be the sixth in a series of annual joint meetings co-hosted by USP and ChP. With the theme, “Partnering Globally for 21st Century Medicines,” the symposium will focus on regulatory and compendial topics relevant to the manufacture of chemical medicines, biologics, herbal medicines and excipients. Invited keynote speakers include Mr. Wang Lifeng, director general of drug registration at China’s State Food and Drug Administration (SFDA); Dr. Roger Williams, chief executive officer of USP; Mr. Wang Ping, deputy director general of ChP, and a repre-sentative from the U.S. Food and Drug Administration.

On day one, four general sessions on the manufacturing areas listed above will highlight industrial, regulatory and pharmacopeial perspec-tives on these topics. The second day will offer presentations by experts from industry, USP and ChP on subjects such as:

• Monographandreferencestandarddevelopmentpractices—perspectives from ChP and USP

• ElementalandorganicimpuritiescontrolinUSP and NF as well as the Chinese Pharmacopoeia

• Assaytransitionsinbiologicalmedicines

• Definingexcipientqualityandmodernizationofexcipientstandards

• Advancesinandinternationalperspectivesontraditionalmedicines

• Legacybiologicproductsandnaturallyderivedmaterials— raising the analytical bar

The symposium will conclude with a final plenary session, “USP and FDA—Partnering Globally.”

For registration information and a symposium agenda, go to http://uspgo.to/S3-Baltimore. g

counts can become dangerously low, mak-ing patients highly susceptible to infections. At times, it becomes necessary to suspend a patient’s regularly scheduled treatment until white blood cell counts have resumed higher levels and immunity is properly boosted. Interruption of a chemotherapy cycle can have deleterious effects on a patient’s overall response to treatment, and filgrastim’s ability to help build immu-nity and prevent infections plays a critical part in optimizing care for the patient.

Filgrastim is a recombinant biologic medi-cine—which means that it is produced with DNA introduced from other sources. By including the monograph for Filgrastim in USP–NF along with its associated Refer-ence Standard, USP is able to maintain a portfolio of standards that keeps pace with the development of biologic medicines. The Filgrastim Reference Standard applies to both the potency assay and physicochemi-cal procedures described in the monograph.

“It’s important that we continue to add rel-evant monographs and reference standards for key biologics like Filgrastim in USP’s portfolio as biologic medicines evolve in the market place,” says Dr. Tina Morris, vice president of USP biologics and biotechnol-ogy department. Other modern biologics for which USP has developed standards include different analogues of insulin that have evolved over time. Today, multiple forms of insulin—such as fast-acting or slow-acting products—are tailored to specific patient needs, and USP continues to develop standards for these newer prod-ucts. As USP develops more monographs and reference standards for recombinant therapeutics, it is also expanding its capa-bilities to develop these materials and to maintain them in house. Later this year, USP will release in PF its bioassay standard for another commonly used recombinant product, epoetin (epo). g

usp.org | 7

monographs. The gen-eral chapter will be of potential use to the biotech-nology community, particularly smaller com-panies that can benefit from validated methods and material reference standards.

As mentioned, three pro-cedures for glycan analysis are included in proposed General Chap-ter <129>. The more than 20 recombi-nant MAbs that have received regulatory approval as therapeutic products belong to a class of antibodies known as the im-munoglobulin G (IgG) class. Glycans can play a critical role in the characterization and appropriate functions of therapeutic IgG MAbs, and knowing how they impact the function and activity of an antibody is important from a regulatory standpoint.

To view proposed General Chapter <129>, go to www.usp.org/usp-nf/pharmacopeial-forum. g

Recombinant mono-

clonal antibodies are

increasingly used

to treat specific types

of cancers, autoim-

mune disorders

and other complex

diseases.

Proposed USP General Chapter Focuses on Recombinant Monoclonal antibodies

In May 2013, USP published a proposed new General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies in Pharmacopeial Forum 39(3). This new general chapter would provide five validated procedures

for purity assessment and glycan analysis of recombinant therapeu-tic monoclonal antibodies (MAbs). A new Reference Standard is also being developed for the two procedures in the chapter related to purity assessment. The deadline for receiving public comments on General Chapter <129> is July 31, 2013.

Today, recombinant monoclonal antibodies represent the fastest growing segment of biopharmaceutical therapeutics, many of which are used to treat specific types of cancers, autoimmune disorders and other complex diseases. Antibodies signal the immune system to attack when a foreign body (e.g., a tumor) is present, triggering an immune reaction. MAbs for human use are derived from a single clone of cells and are made from splicing together genes (thus, the term “recombinant”) that normally would not occur together in nature. The therapeutic use of recombinant MAbs triggers the formation of antibodies with new properties that help in attacking certain diseases.

The analytical procedures included in General Chapter <129> are representative of current industry practices related to MAbs. To evaluate these procedures as well as candidate reference materials, the USP Recombinant Therapeutic Monoclonal Antibodies Expert Panel conducted round-robin studies involving 30 laboratories, most of which were industry-based. Once the general chapter is final-ized and official, USP Expert Committees may apply it in individual

FDa, USP agreement to Produce Safety and Quality Data for Botanicals

Under a new Research Collaborative Agreement signed April 22, 2013, between the U.S. Food and Drug Ad-ministration (FDA) and USP, the two organizations will work jointly on a three-year project to generate scientific

information to assess the quality and safety of botanical ingredients and other identified substances.

FDA and USP will work jointly to develop the use of computer-based data mining, predictive technologies and safety signal detection methodologies as scientifically useful approaches for determining the quality and safety of identified botanical and other substances. The research is intended to enhance the quality of

information for substances evaluated by both groups in order to protect human health.

The work will support FDA’s research on botanical ingredients that may be studied as pharmaceuticals, excipients or dietary supple-ments—the outcome of which may provide decision-support information to FDA. The information will also be used by USP in the safety assessments it conducts for the sole purpose of determining whether a dietary supplement ingredient meets the criteria for ad-mission as a monograph in USP–NF and/or the Dietary Supplements Compendium (such assessments should not be relied upon as any

Continued on page 15. See FDa, USP agreement

| The Standard8

Science and Standards

China Laboratory Is First Satellite Site for USP Spectral Library Network

In March 2013, USP inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network, at the China Shandong Institute for Food and Drug Control (SDIFDC). USP initiated the development of an authoritative and comprehensive

food and drug informatics database in 2012, known as the USP Spec-tral Library project. Once fully developed and operational, the library will be a valuable tool in the development of quality standards using spectral images as well as for material identification and rapid, non-invasive screening of counterfeit and substandard food and drugs.

“The USP Spectral Library project has the potential to help ensure the quality of medicines and foods throughout the world based on partnerships like the one USP has forged with the Shandong Insti-tute for Food and Drug Control,” said Dr. Roger L. Williams, USP’s chief executive officer. “Through the establishment of alliances globally, USP hopes to engage partners worldwide to join USP in its effort to help protect and advance public health.”

Attending the inauguration ceremony for the Shandong site were Dr. Williams and other USP leaders as well as Mr. Chen Shao Ming, director general of the Shandong Provincial Food and Drug Admin-istration; Mr. Xing Ren Dong, director general of SDIFDC; and Ms. Liu Pei, deputy secretary general of the Chinese Pharmacopoeial Commission.

In 2012, Dr. Feng Shi of the SDIFDC spent six months as a visiting scientist at USP and worked on advancing the USP Spectral Library project. Now, as director of the SIFDC Spectral Library Laboratory, Dr. Shi will help lead expanded efforts of the Spectral Library Global

Laboratory Network at the Shandong site. Additional representatives from Chinese provincial laboratories will come to USP headquar-ters in Rockville, as visiting scientists for the USP Spectral Library project, helping to widen the circle of global alliances. To date, visiting scientists from Brazil, China, Myanmar, the Philippines, Russia, Thai-land and Ukraine have participated in this project. As a satellite site for the USP Spectral Library Global Laboratory Network, SDIFDC has allocated 10,000 square feet of laboratory space and the necessary resources to support the development of the spectral library.

Every food and pharmaceutical ingredient and formulated product, together with its packag-ing materials, has a unique set of physical and chemical properties. Collectively, these properties generate characteristic signals, or leave a “fingerprint,” within various regions of the electromagnetic spectrum of wave-lengths that can be probed and captured using analytical instrumentation and advanced informatics. A large collection of spectral fingerprints, also called a spectral library, can aid regulatory authorities, law enforcement agencies, hospitals, pharmacies, manufac-turers and distributors worldwide to screen for potential counterfeit and substandard food and drug substances and products in any part of the world via the Internet.

USP is uniquely positioned to serve the role of central repository of reference spectra from sources throughout the world. To support further development of the Spectral

Library, USP also has established a consortium of representatives from the pharmaceutical industry, leading manufacturers of analyti-cal technologies, regulatory bodies and other pharmacopoeias. USP also has partnered with a European-based analytical software company to develop the informatics infrastructure for the USP Spectral Library.

To fully characterize a substance, USP has adopted an orthogonal methodology for the development of the library, using multiple analytical technologies, including Fourier-Transform Infrared (FTIR) spectroscopy; gas chromatography-mass spectrometry (GC-MS); near infrared spectroscopy (NIR); nuclear magnetic resonance spec-troscopy (NMR); X-ray fluorescence (XRF); and Raman technology, among others, to gather spectral information. Advances in many of these technological areas have enabled the development of hand-held or portable versions of these instruments. USP has engaged several scientific instrumentation companies that are global market leaders in hand-held and portable devices, and is incorporating their expertise on these instruments in the spectral library project. g

The USP delegation, led by Dr. Roger L. Williams, tours the Shandong laboratory.

usp.org | 9

USP Hosts Food and Dietary Supplement adulteration Workshops

In 2012 and 2013, USP convened a series of international workshops to address inten-tional manipulation of foods and dietary supplements. Held in Chile, China and Israel in cooperation with regional partners, these workshops are an extension of USP’s 2009 and 2011 events on this topic held at USP’s Rockville headquarters.

USP worked with country partners to develop balanced programs and ensure a high level of scientific exchange. Common topics included the role of USP compendial standards and related resources such as the USP Food Fraud Database, and current approaches to detect adulteration or ensure authenticity, including both targeted and non-targeted analytical techniques.

The first workshop was held in Valparaiso, Chile, November 8–9, 2012, and was co-sponsored by the Chilean Pharmacopeia Foundation (CPF). Professor Marcela Escobar, CPF Board president and professor at the University of Valparaiso, spoke on a number of subjects including an overview of adulteration of food ingredients in Chile and investigative approaches currently employed to detect adulteration. Mr. Juan Arellano of Chile’s Ministry of Health discussed the Chilean regulatory framework for phytotherapeutic products and foods, and Dr. Gonzalo Cruz of the University of Valparaiso spoke about specific concerns related to adulteration of foods for medical use. On the dietary supplement side, topics included quality control issues for herbal dietary supplements from Mr. Nelson Silva of Knop Laboratory, undeclared pharmaceutically active substances in dietary supplements from Dr. Pablo Jara of the University of Valparaiso, and contributions of pharmacognosy to the determination of adulterants in botanical species from Prof. María Luján Flores of the National University of Patagonia in Argentina.

Drs. Markus Lipp, senior director of food standards for USP, and Carla Mejia, USP scientific liaison, offered information about USP’s work on standards to help prevent the adulteration of specific food ingredients such as spices, skim milk powder and pomegranate; marker sub-stances as an indicator for purity/adulteration; and chromatographic as well as spectrometric methods to detect adulteration. Much discussion was focused on monitoring food and dietary supplement manufacturing sites in the face of limited resources; gaps in fragmented regula-tory systems; and benefits and limitations of USP methods. Attendees cited these methods as valuable tools but noted that they are at times too advanced for all laboratories to utilize, especially in developing countries.

USP also held a workshop on November 29, 2012, in Beijing with the Chinese National Center for Food Safety and Risk Assessment (CFSA). Mr. Jinfeng Liu, director of CFSA, and

USP’s Science & Standards Symposia Engage Stakeholders around the World

Each year, USP hosts science meetings and symposia throughout the world, culminating in the domestic Science & Standards Symposium—this year, held in Baltimore, Maryland, September 18–19, 2013. These meetings serve as forums where stakeholders representing industry, government and academia can learn more about USP’s standards and standards-setting initiatives, and where important scientific information exchanges take place among a global community of experts.

Thus far in 2013, USP has hosted meetings and symposia in Turkey, India, Russia and Mexico, all with the theme of “Partnering Globally for 21st Century Medicines.” The meetings focused on USP’s activities in chemical, biologic and herbal medicines and medical devices, as well as related regulatory and compendial issues in these areas. Speakers of note included Kiran Mazumdar Shaw, Managing Director of Biocon and USP Trustee at Large, who delivered a keynote address on common quality platforms for biological medicines at the India Symposium; and Elena Maksimkina, Director, Russian Department of State Regulation of Medical Products, Ministry of Health, who gave a keynote talk on the regulation of biosimilars at the Russian event.

A preview of the upcoming Science & Standards Symposium in Baltimore can be found on page 6. Agendas and registration information for upcoming meetings and symposia in Vietnam, Korea, Argentina and Brazil can be found at www.usp.org/meetings-courses. g

usp.org | 9

Common topics included the role of USP compendial standards and related resources such as the USP Food Fraud Database, and current approaches to detect adulteration or ensure authenticity, including both targeted and non-targeted analytical techniques.

Continued on page 15. See adulteration Workshop

| The Standard10

Global Health Impact Programs

Center for Pharmaceutical advancement and Training Opens in Ghana

In an effort to develop local talent and improve the technical capacity of staff in regulatory agencies to combat counterfeit and substandard medicines in Sub-Saharan Africa, USP has launched the Center for Pharmaceutical Advancement and

Training (CePAT) in Accra, Ghana. The center aims to be the beginning of a series of global health initiatives to equip national and local regulatory authorities and officers, quality assurance and quality control professionals, manufacturers and others in the pharmaceutical industry with knowledge and skills to promote access to good quality medicines. The new center is also being launched as a Commitment to Action through the Clinton Global Initiative (CGI).

Many Sub-Saharan African countries face a serious problem when it comes to availability of and access to good quality medicines. A 2013 report on the quality of uterotonics (oxytocin and ergomet-rine) in Ghana found that more than 90 percent of the medicines’ samples tested failed the test for either the active ingredient or sterility, and only three of the 26 products tested were officially registered with the Ghana Food and Drug Authority (GFDA). A 2010 study on the quality of anti-malarials in African countries revealed that 44 percent of the samples collected in Senegal failed to meet quality standards. In Madagascar and Uganda, 30 percent and 26 percent of the samples failed, respectively. These reports, and others, underscore the seriousness of the issue and the need for trained professionals to overcome this dilemma.

“CePAT is a natural extension of USP’s core mission of establish-ing public standards for the quality of medicines, foods and dietary supplements. As USP has become increasingly active throughout the world, the need to support efforts to provide good quality medi-cines to everyone who requires them has become more important. CePAT is a positive step in that direction, and has been realized in part through our strong working relationships with the Ghanaian and other Sub-Saharan African medicines regulatory authorities,” said Dr. Roger L. Williams, USP’s chief executive officer.

The inauguration ceremony for the new center occurred in Accra, on May 13, 2013. USP officials, Ghana government officials and U.S. diplomats, including Ghana’s Minister of Health, Sherry Ayitey, and U.S. Ambassador to Ghana, Gene A. Cretz, addressed the attendees to highlight the importance of having a well-trained work-force to be successful in combating substandard and counterfeit medicines, as well as providing access to good quality medicines to the population of Ghana and Sub-Saharan Africa. Mr. Cretz noted that “improvements in this area are critical, and CePAT will play a vital role in tackling this problem. The U.S. President’s Malaria Initiative and USAID activities laid the groundwork for establishing USP in Ghana, and we are proud to be part of this.”

Continued on back cover. See CePaT Ghana Opening

Photos this article: U.S. Embassy in Ghana

Top: The ribbon cutting with (left to right) USP’s Dr. Roger L. Williams; Mr. Gene A. Cretz, U.S. Ambassador to Ghana; Dr. Stephen Opuni, Executive Director, Ghanaian Food and Drug Authority; Ms. Hanny Sherry Ayitey, Ghanaian Health Minister; Dr. Jeffrey L. Sturchio, USP Board of Trustees; and USP’s Dr. Patrick Lukulay. Center: The new CePAT facility in Accra, Ghana. Bottom: Dancers entertain guests at the CePAT inaugural event.

usp.org | 11

Indonesian Manufacturers Seek PQM assistance to Participate in WHO Prequalification Programme

At a March 22, 2013, seminar on the World Health Organization (WHO) Prequalification Programme convened for local medicines

manufacturers and regulators in Indonesia, representatives from regulatory agencies and private companies learned about the process, procedures and requirements to achieve prequalification status. Staff from the Promot-ing the Quality of Medicines (PQM) program, a USAID-funded program implemented by USP, talked about the technical assistance they can provide to help companies reach prequalification for anti-tuberculosis (TB) medicines. Additionally, a speaker from the Global Drug Facility (GDF) presented the outlook on the global TB market.

Jointly organized by PQM, WHO, GDF, and the National Agency of Drug and Food Control (NA–DFC) of Indonesia, the half-day workshop met in conjunction with the Convention on Pharmaceutical Ingredients (CPhI) South East Asia in Jakarta. Each of the sponsoring programs presented and covered such topics as dossier evaluation of anti-TB medicines for registration, and what to expect during a Good Manufacturing Practices (GMP) inspection. A panel discus-sion and Q&A session followed, during which participants interacted with the workshop facilitators and received clarifica-tion on key technical issues surrounding the program, PQM’s technical assistance, and the challenges and obstacles they face in

PQM Study of Maternal Health Care Products in Ghana Finds Many Counterfeit and Substandard Medicines

Post-partum hemorrhaging (PPH) is a major cause of maternal mortality in both developed and developing countries. The World Health Organization (WHO) estimates that severe PPH occurs in about 11 percent of women giving live birth.

The incidence is “thought to be much higher in developing countries where many women do not have access to a skilled attendant at de-livery and where active management of the third stage of labor may not be routine.” (http://apps.who.int/rhl/pregnancy_childbirth/childbirth/postpartum_haemorrhage/sfcom/en/)

Uterotonics, medications used in maternal health to prevent PPH, have proved effective in those settings where healthcare profes-sionals are not readily available, saving thousands of lives. The Promoting the Quality of Medicines (PQM) program, funded by the United States Agency for International Development (USAID) and implemented by USP, has worked with the Ghana Food and Drugs Authority (GFDA) on a post-market surveillance study to assess the quality of uterotonics, after reports of underperforming medications from both the public and the private sector were brought to the agency’s attention. GFDA regulates the manufacture, import, export, supply, storage, distribution and sale of medicines and food in Ghana to ensure quality and safety, as well as to promote public health.

A total of 303 samples were collected from public and private hospi-tals, clinics, medical stores, pharmaceutical outlets and the informal sector across 10 regions of Ghana. The samples were assessed

for source and registration status, cold chain status for injectables, compliance to manufacturers’ recommended storage conditions, the content of the active ingredient (assay) and sterility.

More than 90 percent of the samples tested failed the test for either the active ingredient or sterility. Almost none of the injectables were stored in recommended refrigeration conditions. Only three were officially registered with the GFDA. That prompted regulatory authorities to take immediate steps to recall and collect the products from the market.

Dr. Patrick Lukulay, vice president of Global Health Impact Programs for USP and director of the PQM program, said that based on the study’s results, PQM recommended that GFDA strengthen supply chain compliance, especially with regard to cold chain storage, and develop strict enforcement regulations for product registrations. “Ghanaian regulatory officials have to be given credit, though, for their rapid response in holding people accountable and collecting the poor quality medicines from the market, possibly preventing deaths,” Dr. Lukulay explained.

PQM plans to conduct further rounds of post-marketing surveillance to monitor the quality of uterotonics on the market in Ghana and neighboring countries to determine whether actions taken by regula-tory and enforcement officials had an impact in the market availability and patient access to good quality medicines. g

achieving WHO prequalification. Three additional manufacturers demonstrated interest in learning more about WHO prequalification and in receiving technical assistance from PQM for anti-TB drugs on the GDF/WHO priority list.

While in country, PQM specialists in GMP conducted follow-up assessments at three local manufacturing sites for anti-TB medicines and a contract research organiza-tion already taking part in the PQM technical assistance program. The team evaluated the progress each had made on implementing corrective and preventive action recom-mendations from previous PQM and WHO inspections. g

| The Standard12

On April 24, 2013, the eve of World Malaria Day, U.S. Food and Drug Administration (FDA) Com-missioner Dr. Margaret A. Hamburg presented a dire scenario of how malaria is still a daunting

public health threat in Africa. Malaria kills more than 660,000 people globally each year, mostly children. With more than 90 percent of the world’s malaria deaths occurring in Africa, the commissioner reported, “The disease is getting harder to treat due to drug resistance, limited availability of medica-tion, and distribution of counterfeit or substandard anti-malarial medicines.”

One way to try to minimize patient exposure to counterfeit medicines is to increase monitoring of drug supplies before they reach the marketplace, or to use tools that can be easily deployed in the field to identify and recall falsified products. CD-3, a handheld, battery-operated device developed by the FDA’s Forensic Chem-istry Center in Cincinnati, Ohio, allows rapid screening of tablets, capsules, powders and packaging, using wavelengths of light including ultraviolet and infrared. This allows rapid comparison of suspect products to the authentic ones.

A CD-3 testing program will be headed by a public-private partnership, including FDA, USP, the Skoll Global Threats Fund, the National Institutes of Health, the Centers for Disease Control and Prevention and the multi-agency President’s Malaria Initiative (PMI), led by the U.S. Agency for International Development (USAID).

CD-3s will be deployed in Ghana, where USP with support from PMI has established drug monitoring sites as part of Promoting the Quality of Medicines (PQM) program activities. PQM is implemented by USP and funded by USAID and the PMI.

Dr. Patrick Lukulay, vice president of Global Health Impact Programs at USP and director of PQM, says CD-3 screenings will occur at five PQM sentinel sites in Ghana where existing minilabs are currently deployed. The monitoring sites in Ghana were established based on several criteria: geographical location, including vulnerable areas such as borders with other countries; areas where the incidence of malaria is high; and locations where the Ghanaian Food and Drug Authority has provincial offices and staff.

“The PQM program in the country is effective and the Ghanaian Food and Drug Authority has demonstrated resolve in taking action to combat falsified medicines, making Ghana a good place to pilot this complementary tool,” Dr. Lukulay stated when the FDA launched the new tool in April 2013.

Samples of anti-malarial medicines brought to the sites will be obtained from various points in the distribution chain in Ghana, including hospitals, clinics and pharmacies (public and private). Confirmatory testing of suspect products will be done at the national quality control laboratory and provided to Ghanaian regulatory authorities responsible for government enforcement action.

Other regions affected by high rates of malaria and equally challenged by the increasing dis-tribution of substandard and counterfeit medications will potentially serve as sites for future testing programs, informed with the experience gained by the program in Ghana. g

Global Health Impact Programs

USP to assist FDa in Testing New Counterfeit Detection Device

Photo: U.S. Food and Drug Administration

CD-3 shows visible differences between

authentic (right) and counterfeit (left) alli

packaging. CD-3, a small portable device

invented by FDa scientists, is being deployed

to screen for counterfeit and substandard

malaria drugs in Sub-Saharan africa and

Southeast asia. Using wavelengths of light,

CD-3 reveals differences between authentic

and counterfeit drugs that look the same to

the naked eye.

usp.org | 13

Inside USP

Mid-Cycle Meeting Begins USP’s Preparation for the Future

USP convened its Mid-Cycle Meeting February 10–12, 2013, in Carefree, Ariz. This is the only occasion when the organization’s volunteer groups—the Board of Trust-ees, Council of Experts, Council of the Convention and

Convention’s Governance Committee—will meet together during this five-year cycle, until the next Convention in 2015.

To begin, each volunteer body met separately to discuss its particular vision for USP’s future and what contribution the body will make to advance that vision. After these initial breakout sessions, USP chief executive officer Dr. Roger L. Williams presided over a management overview ses-sion—offering key updates on the CEO transition in advance of his June 2014 departure from USP, USP’s new logo and branding initiative (more information on page 14) and the results of a volunteer satisfaction survey recently conducted by USP, which showed high satisfaction among USP’s volunteer bodies while identifying some potential areas for improvement.

Following Dr. Williams’ update, Dr. Timothy Franson, president of the USP Convention and chair of the Council of the Convention (CoC), led a session on the CoC. The CoC is a smaller, representa-tive subset of the full USP Convention membership. Dr. Franson reviewed the CoC’s vision—which includes 100 percent member-ship engagement; impactful, forward-thinking resolutions; and the best science and processes. CoC member Mr. Glen Fine provided a brief summary of work to expand the Convention membership—noting that the CoC is working to significantly grow its international participation by the time of the 2015 Convention Meeting. CoC member Mr. Tom Menighan then discussed the CoC’s 2012–2013 Listening Tour (summarized in the Spring 2012 edition of The Stan-dard). Mr. Menighan outlined the next steps in the development of resolutions that will be voted on at the 2015 meeting and will guide USP in the next cycle.

The Council of Experts (CoE)—composed of 24 chairs who lead more than 900 volunteers serving on Expert Committees and Panels—offered perspectives on how they viewed USP’s standards-setting position for the future. Dr. Srini Srinivasan, chief science

officer and executive vice president at USP, summarized the CoE’s thoughts on the primary focus areas for USP across six overarching topical categories (chemical medicines, excipients, biologic medi-cines, dietary supplements and food ingredients, general chapters and healthcare quality standards). Their thoughts included clarifying monograph prioritization for chemical medicines; working to expand

coverage of excipients moving in international commerce be-yond those legally marketed in the United States; under-standing and building on the relationship between USP–NF and Medicines Compendium biologic monographs; modern-izing procedures in the Dietary Supplements Compendium and Food Chemicals Codex; keeping general chapters smaller and easier to use; and increasing emphasis on patient issues and safety standards.

Presenting on behalf of the Governance Commit-tee (GC), Mr. Donald Singer provided an update on the GC’s approach to bylaws changes leading up to the 2015 meeting. He noted that the GC’s vision is to deliver

bylaws that are reflective of a growing and dynamic organization in language intended for a global audience. Despite this, Mr. Singer said he hoped there would be only minimal changes to the bylaws, given they were comprehensively rewritten in 2010. He asked all the groups present to look carefully at the sections of the bylaws pertinent to their work and submit to the GC any recommendations for amendments by Fall 2013. He promised that the GC would consider their input carefully.

Dr. Duane Kirking, chair of the USP Board of Trustees, rounded out the updates with an overview of significant decisions made by the Board during the current cycle. These decisions included the endorsement of an overall globalization plan, approvals of expan-sions for USP’s India and China sites and approval of USP’s new training center in Ghana (see article on page 10). Dr. Kirking also presented the Board’s updated Strategic Plan for USP, seeking feedback from attendees. The revised plan, which was subse-quently adopted in May 2013, essentially contains the same five elements: 1) Strengthen and Expand Core Compendial Activities,

Dr. Timothy Franson, president of the USP Convention; Ms. Diane Dorman of the National Organization for Rare Disorders; and Dr. John Punzi of the Consumer Healthcare Products Association.

Continued on page 14. See MId-Cycle Meeting

| The Standard14

Inside USP

New Logo for USP Evokes Global Health Mission

Mid-Cycle Meeting Continued from page 13

2) Build and Enhance USP’s Allied Compendial Programs, 3) Explore and Evaluate Emerging Public Health Opportunities, 4) Operate Glob-ally to Maximize Impact and 5) Manage Efficiently and Effectively. The plan does differ in some small but significant ways. For instance, as part of strengthening and expanding core compendial activities, the plan now emphasizes a) strengthening USP’s own capabilities to develop and modernize monographs, b) facilitating access to USP standards especially in developing countries and c) promoting harmonization and advancement toward global quality standards. The Mid-Cycle Meeting, for the first time, included an open Board of Trustees meeting and allowed all the attendees to achieve a better understanding of the Board proceedings.

Throughout the meeting, there was discussion on a host of critical issues, including the structure of governing bodies such as the Council of Experts, USP’s relationship with the U.S. Food and Drug Administration and challenges with the traditional donor model of monograph acquisition.

As the USP 2015 membership meeting approaches, the USP leader-ship will explore and expand upon the key discussions at this meeting via a series of topical conclaves. These conclaves will inform white papers for consideration by USP volunteers, staff and the public regarding the future direction of USP. The white papers may result in resolutions at the 2015 Convention Meeting. g

C elebrating nearly two centuries of dedication to science, standards and health, USP unveiled a new logo and tagline on April 15, 2013, that convey the organization’s key role in helping to ensure the quality of medicines

and foods around the world. USP’s new look is a visual expres-sion of the principles embodied in the organization’s strategic plan, which articulates a truly global vision supported by organizational initiatives and beliefs. Remaining committed to strengthening and expanding its core compendial mission, USP also will continue building allied compendial programs and exploring emerging health needs. The new logo and the strategic plan both grow out of USP’s fundamental strengths: global expertise and trusted standards that improve health.

“USP’s transformation since its founding by 11 physicians in 1820 has truly been remarkable,” observed Dr. Roger L. Williams, USP’s chief executive officer. “As an organization, we remain deeply rooted in our practitioner history while keeping pace with dramatic changes in the science, technology, industry, human needs and global regulatory environment for medicines, foods and supple-ments. Because USP is a private, independent organization, it is well positioned to convene stakeholders representing diverse areas of expertise and national backgrounds, all with the goal of advanc-ing health around the world. USP’s strategic plan and the new logo and tagline both represent this. It is something our many volunteer experts, Convention members, staff and other stakeholders can be proud of. And—most importantly—providers, patients and consum-ers all benefit from USP’s ongoing commitment to good-quality medicines and foods.”

Nearly two centuries ago, USP’s founders sought to bring qual-ity and uniformity to medicines in the United States. Today, USP remains committed to that mission, broadened to achieve global impact. Stakeholders will see a transition period during which both the new and old logos will appear; over time, and in a phased manner, the new logo will completely replace the old. g

3

1

2

4

5

6

The abbreviated name “USP” is retained, which is known around the world and is strongly associated with both scientific rigor and health impact.

The organization’s formal name is added—U.S. Pharmaco-peial Convention. This emphasizes USP’s non-governmental status (nearly unique among the world’s pharmacopoeias) as well as the 450 health-focused organizations that com-prise the Convention membership.

The logo colors have softened, from black and metallic gold to blue and a warmer golden shade. The clean, contempo-rary font was created by USP specifically for the new logo.

The logo incorporates a gold sphere, signifying USP’s reputation as “the gold standard” of quality, the globe that USP serves and aspirations for universal access to good-quality medicines, foods and supplements.

The “P” and “C” are combined into a single, open-ended character signifying the unity of the Convention with its collaborative standards-setting process.

Together, the new logo and tagline reflect USP’s global expertise in developing trusted standards for drugs, food ingredients and dietary supplements—which results in improved health around the world.

Notable elements of the new logo include:

1

2

3

4

5

6

usp.org | 15

The Standard

First Ingredients Proposed for Public InputWith the May 20 launch of HMC, USP proposed the first 23 monographs for comment. These are:

• Phyllanthus amarus Aerial Parts• Phyllanthus amarus Aerial Parts Powder• Phyllanthus amarus Aerial Parts Powdered Extract• Rhodiola rosea Root and Rhizome• Rhodiola rosea Root and Rhizome Powder• Rhodiola rosea Root and Rhizome Powdered Extract• Rhodiola rosea Root and Rhizome Tincture• Salvia miltiorrhiza Root and Rhizome• Salvia miltiorrhiza Root and Rhizome Powder• Salvia miltiorrhiza Root and Rhizome Powdered Extract• Ganoderma lucidum Fruiting Body• Ganoderma lucidum Fruiting Body Powder• Ganoderma lucidum Fruiting Body Powdered Extract• Lagerstroemia speciosa Leaf• Lagerstroemia speciosa Leaf Powder• Lagerstroemia speciosa Leaf Powdered Extract• Trigonella foenum-graecum Seed• Trigonella foenum-graecum Seed Powder

Herbal Medicines Compendium Continued from front cover

• Trigonella foenum-graecum Seed Powdered Extract• Trigonella foenum-graecum Seed 4-Hydroxyisoleucine

Powdered Extract• Panax pseudoginseng Root and Rhizome• Panax pseudoginseng Root and Rhizome Powder• Panax pseudoginseng Root and Rhizome Powdered Extract

These monographs will be open for a 90-day comment period before they are reviewed and balloted for adoption by the USP Council of Experts as authorized monographs. Stakeholders will be able to submit comments directly within the website for the USP Council of Experts to consider, and each monograph has an associated discussion forum to allow for real-time exchange among stakeholders worldwide. An additional 20 monographs in the For Development category also are available on the HMC website. After monographs become authorized, comments may still be submitted for consideration by the USP Council of Experts for possible future revisions.

For more information about HMC, including frequently asked questions, and to view and comment on proposed monographs, visit http://hmc.usp.org. g

Mr. Zhutian Wang, assistant director of CFSA, opened the event along with USP CEO Dr. Roger L. Williams. Key remarks were offered by Dr. Christopher Hickey of the U.S. Food and Drug Administration’s China office on the agency’s role in promot-ing the safety of the food ingredients and dietary supplements trade. Dr. Andrew Ebert, chair of USP’s Food Ingredients Expert Committee, offered an overview of the Food Chemicals Codex (FCC) and its im-portance as basis for food safety programs. Dr. Robert Buchanan, a member of the USP Board of Trustees, and Dr. Huang Bin, director of the Department of Registration, Certification and Accreditation Administra-tion of the People’s Republic of China,

focused on vulnerability assessments of food manufacturing plants.

The final workshop in the series was co-sponsored by the Ministry of Health of the State of Israel (MHI). Held March 11–12, 2013, in Tel Aviv, participants learned how USP fits into the Israeli regulatory frame-work from Dr. Shay Chen, national inspec-tion coordinator in the Food Control Service of MHI. Dr. Einat Haleva of the Israeli Public Health Laboratory (and a member of the Food Ingredients Expert Committee) spoke about the analysis of adulterants in food products. The analytical perspective on counterfeit dietary supplements in Israel was shared by Dr. Zippora Hes, head of

adulteration Workshop Continued from page 9

the Chemistry Laboratory in the Institute for Standardization and Control of Pharma-ceuticals, MHI.

As USP and its partners evolve their work to meet the challenges posed by adultera-tion of foods and dietary supplements, these workshops will continue to be valu-able forums for information sharing. USP will host its next meeting on this topic September 26–27, 2013, in Rockville, Md.

More information is available at www.usp.org/meetings-courses/workshops/economically-motivated-adulteration-food-ingredients-and-dietary-supplements. g

finding about the intrinsic safety or effec-tiveness of a dietary supplement). More information about USP safety assessments for dietary supplements is available at www.usp.org/dietary-supplements/development-process/revisions-commen-tary-errata/admission-criteria-and-safety-classification-dietary.

FDa, USP agreement Continued from page 7

Beyond botanicals, the knowledge gained from this work may be used to improve the methodologies that FDA and USP use for assessing drug products and related substances, such as impurities.

Results from the computational models gen-erated from the project will be interpreted

by the appropriate USP Expert Committee and will enable USP and FDA to make better decisions when addressing data from con-ventional in vitro and in vivo bioassays and human clinical studies. USP and FDA will work to make results of the collaboration publicly available through publications and public presentations. g

Headquarters

12601 Twinbrook Parkway Rockville, Maryland 20852 U.S.A.

+1-301-881-0666 1-800-227-8772 (U.S. and Canada)00-800-4875-5555 (Select Europe)

Europe/Middle East/africa

Münchensteinerstrasse 41 CH-4052 Basel, Switzerland

+41 (0)61 316 30 10

USP–India Private Limited

IKP Knowledge ParkTurkapally VillageGenome ValleyShameerpet, Ranga Reddy DistrictHyderabad 500 078, A.P., India

+91-40-4448-8888

USP–China

Building 11Lane 67, Libing RoadZhangjiang Hi-Tech Park201203 Shanghai China

+86-21-51370600

USP–Brazil

Avenida Ceci, 1600 - TamboréBarueri-SP 06460-120Brazil

+55-11-3245-6400

www.usp.org

Copyright © 2013 The United States Pharmacopeial Convention. All Rights Reserved.

GA055NL_2013-06

What Will CePaT Offer?CePAT’s first course offerings in the region are on Medicines Dossier Evaluation, Quality Control (including hands-on laboratory training) and Good Manufacturing Practices for Pharmaceuticals. Classes are expected to start July 8, 2013. Applicants will be subject to a pre-evaluation to ensure that those chosen to participate can benefit most from the train-ing, based on their potential to make a positive contribution to the evolving regulatory landscape in the Sub-Saharan African region.

“Serious public health issues related to poor quality medi-cines have been linked to lack of trained human resources in countries with limited resources” said Dr. Patrick Lukulay, vice president of Global Health Impact Programs at USP, who also oversees CePAT operations. “With the center, we want to bring the opportunity to improve local quality assur-ance systems by training national regulatory agencies and quality control professionals so they can fight the problem of fake and substandard medicines in a sustainable way.”

CePAT facilities also will serve as a reference laboratory for testing suspect medicines in Sub-Saharan Africa. Dr. Lukulay highlights that, “USP has been implementing the Promoting the Quality of Medicines [PQM] program with USAID funds for nearly 10 years, and we have made excellent headway in the fight against substandard and counterfeit medicines. With PQM, we have been able to test mostly medicines that are priorities to USAID, such as anti-malarials and medicines for HIV/AIDS and tuberculosis. At CePAT, we hope to expand that capability to include more medicines that are equally important to public health and the population of Ghana and Sub-Saharan Africa.”

Sustainability as a Goal for the Region Even though CePAT will be primarily funded by USP for the first three to five years, it will eventually become sustainable through the support of private donors, governments and regulatory agencies who share a commitment to continued training of personnel responsible for compliance. The private sector will also be encouraged to send quality control experts to learn how to comply with good manufactur-ing practices, an incentive to regional manufacturers that wish to produce medicines to compete with the overseas sources, from which most of the poor quality medicines are currently imported.

“We hope the CePAT model in Sub-Saharan Africa is successful to the point where our partners in this initia-tive will see value in expanding it to other regions in the world facing the same problems. Combating substandard and counterfeit medicines is not a challenge unique to Sub-Saharan Africa, and we are confident that we can be part of the solution,” says Dr. Lukulay.

For more information about CePaT, visit http://uspgo.to/CePaT-program. g

CePaT Ghana Opening Continued from page 10