basic concepts of quality assurance & management
TRANSCRIPT
Quality Assurance & ManagementBasic Concepts And Ideas
Anirban SahaM.Pharm (Pharmaceutics)Year- 1st , Semester- 2Amity University.
AMITY INSTITUTE OF PHARMACY
Outlineo Definitions.o Quality & Its Importance.o Introduction.o Characteristics of QA Programme.o How is quality assessed and assured ?o Quality Management And its Systems.o Quality Assurance for Excipients.o Quality Assurance for API.o Quality Assurance Of Packing Materials.o Some general tests of packing materials.
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Quality Assurance (QA)—Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient
Quality Control (QC)—Process concerned with medicine sampling, specifications, and testing, and with the organization’s release procedures that ensure that the necessary tests are carried out and that the materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory
Definitions
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Quality Management (QM)—A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications.
Good Manufacturing Practices (GMP)—Performance standards that WHO and many national governments established for pharmaceutical manufacturers covering, for example, personnel, facilities, packaging, and quality control.
Definitions
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Quality is “totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs”.
o The ability to make the same thing the same way, over and over again.
o Customer buys today is same as what they bought last week or will buy next week.
o Product meets customer’s expectations 100% of the time.
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What is Quality
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Business success may simply be the extent to which any organization can produce a higher-quality product or service than its competitors are able to do at a competitive price. When quality is the key to a company’s success, Quality Management system allow organizationsto: o Keep up with and meet current quality levels.o Meet the consumer’s requirement for quality.o Retain employees through competitive
compensation programs.o Keep up with the latest technology.
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Why Is Quality Important ?
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Introduction:
Goals of QA Programs:-
To make certain that each medicine reaching a patient is safe, effective, and of standard quality.
Obtaining quality products that are safe and effective through structured selection and procurement methods
Maintaining quality products through the appropriate storage, distribution, monitoring, and use by prescribers, dispensers, and consumers
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Characteristics of a QA Program
o Medicines are selected on the basis of safety and efficacy, in an appropriate dosage form with the longest shelf life.
o Suppliers with acceptable quality standards are selected.
o Medicines received from suppliers and donors are monitored to meet quality standards.
o Medicine packaging meets contract specifications.
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o Repackaging activities and dispensing practices should maintain quality.
o Adequate storage conditions in all pharmaceutical areas are maintained.
o Transportation conditions are adequate.
o Product quality concerns are reported and monitored.
Characteristics of a QA Program
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Total Procedure
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o INSPECTION of raw materials and API on arrival.
• Visual inspection• Product specification review (including expiry dates)
o LABORATORY TESTING for compliance with pharmacopoeial standards.
• International Pharmacopoeia• European Pharmacopoeia • U. S. Pharmacopeia • British Pharmacopoeia • National Pharmacopoeia
o BIOAVAILABILITY DATA
How Is Quality Assessed?
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o Product selection• Long shelf-life. • Acceptable stability.• Acceptable bioavailability.
o Selection of appropriate suppliers• Supplier pre-qualification.• Request samples from new suppliers.• Request specific reports and data for certain medicines (e.g.,
bioavailability and stability studies).• Collect and maintain information on supplier performance.
o Product certification• GMP certificate of manufacturer.• Product/batch certification (COA).• Random local testing.
How Is Quality Assured?
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How Is Quality Assured?
Some other aspects:-• Appropriate storage, transport, dispensing, and use
procedures.• Pharmaceutical distribution and inventory control
procedures.• Provision for appropriate storage and transport
including adequate temperature control, security, and cleanliness.
• Avoidance of repacking unless quality control is required
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Who Ensures Medicine Quality?
Drug Regulatory Authority
MedicineQuality
Physicians and other prescribers
Drug and Therapeutics Committee
Hospital procurement office
Pharmacy (and dispensers)
Patients
MedicineQuality
Physicians and other prescribers
Drug and Therapeutics Committee
Hospital procurement office
Pharmacy (and dispensers)
Patients
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What Purpose Does a Quality Management System Serve?
✔ Establishes a vision for the employees.✔ Sets standards for employees.✔ Builds motivation within the company.✔ Sets goals for employees.✔ Helps fight the resistance to change within organizations.✔ Helps direct the corporate culture.
Quality Management
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o ISO 9000 is a series of quality management systems (QMS) standards created by the International Organization for Standardization, a federation of 132 national standards bodies.
o The ISO 9000 QMS standards are not specific to products or services, but apply to the processes that create them.
o The standards are generic in nature so that they can be used by manufacturing and service industries anywhere in the world.
o An organization that would like to have ISO certification needs to meet all the criteria stated in the ISO standards and pass a detailed audit performed by an ISO auditor.
Standardized Systems
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Elements of Pharmaceutical Quality System:
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Fundamental elements for effective pharmaceutical quality systems are as follows:
• Managerial review of process performance and product quality.• Process performance and product quality monitoring system.• Corrective action and preventive action (CAPA) system.
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Management responsibility: Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Management has the responsibility to achieve quality related goals as per the quality policy.
o There must be a clear understanding and unambiguous set of authority and responsibility at all levels including individual and collective role.
o Strict commitment toward the quality objectives should be demonstrated.
o Management should participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.
Aims Of Quality Management
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Continuous improvement in process performance and product quality:
o Product quality depends on appropriate design of quality attributes during product development phase.
o Technical knowledge or specification, control strategy and validation approaches should be effectively transferred within or between manufacturing sites for commercial manufacturing.
o Product discontinuation aspects include retention of relevant
documents, samples and review of product assessment, complaint handling and stability related problems as per regulatory provisions.
Aims Of Quality Management
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What Is the Need for Quality Assurance of Excipients?
o Excipients Need to be Safe and Provide Consistent Quality including Performance.
o Excipients must be manufactured in accordance with CGMP.
o Drugs are approved with the premise that excipients used in exhibit batches are going to remain consistent while the drug is on the market.
Quality Assurance For Excipients
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o The amount of excipients quite often exceeds the amount of API in any given drug.
o Excipient purity is difficult to determine for many excipients.
• –Heterogeneity of the chemical composition is common for many excipients whereby the excipient is still considered to be a “pure drug substance”
• –Test methods often fail to account for anywhere near 98%, whereas we generally regard 2.0% to be the upper limit for substances regarded as unnecessary if not deleterious to safety or efficacy of a drug.
Concerns about Excipient Purity
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o Globalization and Cost Pressures Have Changed the Playing Field
• Greater uncertainty about integrity of supply chain.• Confirmed incidents involving intentional
adulteration suggesting the risk, as far as the US supply chain, has increased.
• Pressure leading to shortcuts and risk taking which might not be in best interest of patient safety.
Concerns about Excipient Purity
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Quality assurance is a wide-ranging concept that covers all matters that individually or collectively influence the quality of an API. It is the total of the organized arrangements made with the objective of ensuring that APIs are of the quality required for their intended use. Quality assurance therefore incorporates GMP, along with other factors that are outside the scope of these guidelines.
Quality Assurance for API
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A system of quality assurance appropriate for the fabrication, packaging, labelling, testing, distribution, importation, and wholesale of APIs should ensure that:
o APIs are designed and developed in a way that takes into account the GMP requirements.
o Each fabricator should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. Managerial responsibilities should be clearly specified.
o Systems, facilities and procedures are adequate and qualified, whether they are new or modified;
o Production and control operations are clearly specified.o Analytical methods and critical processes are validated.
System Of Quality Assurance for API
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o Arrangements are made for the supply and use of the correct raw and packaging materials.
o All necessary control on APIs and any other in-process monitoring is carried out.
o Outsourced activities are subject to appropriate controls and meet GMP requirements.
o Fabrication, packaging/labelling, testing, distribution, importation, and wholesaling are performed in accordance with established procedures.
o APIs are not released for sale or for further fabrication before the authorized person from the quality control department has approved that each lot has been produced and controlled in accordance with the approved specifications.
o Satisfactory arrangements exist for ensuring that the APIs are stored, distributed, and subsequently handled in such a way that quality is maintained throughout their expiry or retest date.
System Of Quality Assurance for API
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Any company that sells or distributes packaging, packaging components, or packaged products is responsible for compliance with state toxics in packaging laws, regardless of where the regulated metals originated. Based on the experiences of regulated entities, it has become very clear that packaging specifications and the assurance of suppliers are not always enough to ensure the quality of packaging materials.
Quality Assurance for Packing Materials
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o Keep records of pack specs. agreed with suppliers.
o Keep examples of previously supplied, acceptable packs, for reference & comparison.
o Employ basic measuring methods to check pack dimensions/weights/compressive strength, etc.
o Maintain close relations with pack suppliers, exchanging & comparing QA findings.
o Have access to specialist QA & test services with regard to particular pack materials & problems.
Recommended Quality Assurance Practice and Procedures
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Strength tests:-Bursting strength (Mullen; tests drop resistance).-Edge crush (tests rigidity, stacking strength).-Flat crush (tests compression resistance).-Puncture (tests resistance to puncturing/shocks).Other tests:-Adhesion tests (adhesion of paper plies and of liners to fluting).-Moisture resistance (Cobb; water absorption test).
Specific tests of Paper/Board Packaging
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•Tensile test & stretch/elongation test.•Tear test, machine & cross direction (Elmendorf test).•Moisture vapour transmission test.•Gas permeability tests (oxygen, CO2, odours).•Resistance to product, solvents, oils and greases.•Heat and cold (re filling temperatures, etc.); climatic and ageing tests.•Heat sealing strength tests.
Specific tests on plastics packaging
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•Pressure testing.•Leakage testing.•Closure/seal testing (including closing torque/ease of opening).•Compression testing.•Drop testing.•Climatic (temperature & humidity) testing/accelerated ageing.
Specific Tests on rigid packaging (bottles, cans, etc.)
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•Print rub/scuff resistance/adhesion tests.•Resistance to product constituents/solvents.•Registration accuracy/uniformity.•Print definition/clarity/legibility.•Colorimetric accuracy/consistency of tones and shades (compared to reference colour samples).•Resistance to fading (accelerated ageing test).
Printing Inspection and Testing
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•Compression/top load tests (empty & filled packages).•Leakage/seal/closure failure tests.•Simulated transit tests with filled packages: drop test; vibration test; inclined plane impact test; revolving drum test; humidity and temperature resistance tests.•Accelerated aging tests.
Tests on filled/closed packages
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www.ncbi.nlm.nih.gov/pubmed/19289341
www.fda.gov
www.fda.gov/downloads/ICECI/ComplianceManuals/.../UCM125420.pd
Quality Assurance Of Drugs in Pharmaceuticals, P.D.Sethi, Vandana Publ, New Delhi.
Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Good manufacturing practices and inspection, Volume 2, WHO.
References:
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