presentation by mr. edward wyszumiala general manager nsf international

7/21/2019 Presentation by Mr. Edward Wyszumiala General Manager NSF International

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NSF InternationalThe Public Health and Safety Company

Nutraceuticals Functional Foods and Dietary

Supplements

2

nd

International Conference

24/7 GMP Compliance and Readiness

™



Topics to be Covered

• Who and What is NSF

• What are the purpose of GMPs

• Common areas of non-compliance of GMPs

• Questions



Who is NSF International?

• The global leader in Dietary Supplement and Ingredient

Certification and GMP Registrations• Developer over 60 national consensus standards

• Steadfast ties with key associations and government agencies,

such as U.S. FDA and Health Canada

• A Collaborating Centre for the World Health Organization



Our Mission has always focused on

Protection of Public Health and Safety

NSF International, an

independent, not-for-profit

non-governmental

organization, is dedicatedto being the leading global

provider of public health

and safety-based risk

management solutions

while serving the interestsof all stakeholders.

Our core purpose is to protect and improve human health.



We are Uniquely Positioned to Objectively

Coordinate Stakeholder Interests

Health Canada, US FDA,

NIH, ODS

Dietary Supplements,

Food, Water, Air

Media, Educators,

Consumer Groups

Consumers

egul tors

Industry



What are Good Manufacturing Practices



Certifications that NOT GMP programs

There are a number of quality systems and

certifications available but they do not define or meet

GMP requirements.

ISO 9000

HAACP

Organic Certification

Halal Certification

Kosher Certified GFSI: BRC, SQF, Global Gap, ISO 22000



What are GMPs?

Good Manufacturing Practices establish the minimum

necessary activities related to manufacturing,

packaging, labeling, or holding dietary supplements

to ensure the efficacy, quality purity and safety of thedietary supplement

The fundamental principle behind GMPs is that you

cannot test quality into a finished product, you have

to build it in the manufacturing process.



Who does GMP apply to?

• GMP regulations effects companies that

manufacturer, package, label or hold dietary

supplements, and requires qualification and

monitoring of a company’s supply chain

• In the United States, for example, GMP regulations

apply to all dietary supplements sold and marketed

in the United States, even those made outside ofthe United States, including India.



Manufacturing Quality is determined by

GMP Compliance

Everything that takes place in the manufacturing

process effects product quality.

Including Raw Material Qualification

Preventative Maintenance

Employee Actions

Documentation

Cleaning

Testing



And Quality is Related to Profitability

Regulator Finds Customer Finds

Manufacturer Finds Manufacturer Prevents



Dietary Supplement Specific GMPs



Similar areas of Food vs. Supplement GMPs

• Pest Control

• Trash Disposal

• Water Supply

• Sanitation Supervision and Management

• Maintenance of Plant and Grounds

• Cleaning procedures

• Documentation management



Similar areas of Pharma vs. Supplement GMPs

• Testing of Incoming Materials

• Setting of Product and Ingredient Specifications

• Laboratory Records

• Master Manufacturing Records

• Sample Retention

• Personnel training



Common Areas for Non-Compliance



Testing of incoming raw materials

• Every incoming dietary ingredient must be tested

• Component specifications must be set to ensure purity,strength and composition are engineered into a product.

• All incoming ingredients must be subjected to identity testing,and verification that the incoming raw material meets thespecifications as set by the manufacturer.

• Certificate of Analysis’s may be used from a supplier if themanufacturer has qualified the supplier, through auditing andtesting. It is the manufacturer’s responsibility to ensureadequate controls are met to ensure identity, purity andquality of raw materials.



Qualification of Suppliers & C of A’s

• How did you qualify the supplier? Raw materials,packaging, and components?

• What parameters and testing data are used to

support the reliance of the data on the C of A?

• Have you or an accredited third party audited yoursupplier for GMP compliance?

• Does your program go far enough: testing,auditing, and frequency?



Contamination

• GMPs do not establish upper limits for microbialcontamination

• GMPs do not set levels for heavy metal contamination in thisregulation for dietary supplements.

• It is the responsibility of the manufacturer to identifycontaminants and establish limits as to prevent adulteration

• For example, in the U.S. irradiation is no longer allowed in

addressing microbial loads. If irradiation is used, a companymust file a food additive petition to FDA , and make the claimon the product’s label.



Batch Records

• Do your batch records provide for traceability of theraw materials, components and labels used as well

as equipment used in production

• Make sure you have proper sign-offs at each step

of the process

• Document cleaning and sanitation of equipment

• How to handle reprocessing, if necessary?



Paperwork, Documentation and SOP’s

• A solid GMP system is a document intensiveregulation, that is focused toward process controls,SOP’s and record keeping

• Solid SOP’s are fundamental in creating arepeatability and engineering a consistent productfrom batch to batch

• SOPs should be representative of the activitiestaking place at the facility

• If it is not documented, it doesn’t exist!!!



Preventing contamination

• Does your facility have proper metal detection as

part of the manufacturing process?

• Backflow systems on all hose connections

• Hands free faucet controls

• Proper usage or hair restraints, gloves, lab coats

and foot covers



Conclusions and Takeaways

• Perform an internal GAP analysis of where your programsmay have shortcomings and need to be strengthened

• All of your staff must be trained in GMP compliance and

understand their roles and responsibilities

• Make sure your paperwork is fully thought through and

documented, especially for batch records and testing

• Full GMP compliance will take time, effort and investment.Develop a budget and plan to help ensure your company is

on track for compliance



NSF GMP Program



Good Manufacturing Practices(NSF/ANSI Standard 173, Section8)

• Objective of GMPs:

– GMPs provide specific standards for themanufacturing, packaging, warehousing and

distribution of dietary supplements

– Audit to verify that process is working properly

– Testing to assuring quality: Testing of rawmaterials to finished product

• All requirements for the GMP audit are outlined inSection 8 of the American National StandardNSF/ANSI 173 for Dietary Supplements



GMP Registration Program

Section 8 of NSF 173

• Annual full GMP audits (2-3 days)

• Annual follow-up monitoring audits (1day)

• A facility will become NSF Registered and listed

on our website when they meet all of the

requirements of the NSF GMP program as

outlined in Section 8 of NSF/ANSI Standard 173.



Questions



Edward WyszumialaDietary Supplement and Functional Food Programs

General Manager

[email protected](734) 913-5706

Ann Arbor, MI

presentation by mr. edward wyszumiala general manager nsf international

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