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The Relationship Between QA,
QC and GMP
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The following definitions are adapted from the ‘Orange Guide’ published by the Medicines Control Agency of the United Kingdom and are essentially identical with definitions to be found in the European Community and WHO Guidelines for Good Manufacturing Practice.
National and International Standards exist for Quality Systems which provide models for Quality Assurance within different industrial environments (e.g., British Standard BS5750 and the equivalent ISO9000 series of standards).
Quality Assurance (QA) is a wide ranging concept and covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors.
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification.
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
Information
In addition to the UK Orange Guide and the various GMP guidelines, several other documents are of particular value. These are:
1. The European Pharmacopoeia Monograph on FMD, ‘Vaccinum Aptharum Epizooticarum Inactivatum Ad Ruminantes’, and other sections of the EP covering sterility testing, abnormal toxicity testing and the use of alternative tests to those prescribed in the Monograph.
2. OIE Manual of Standards for Diagnostic Tests and Vaccines. Foot and Mouth Disease. This embraces all of the EP Monograph on FMD and is a particularly useful and current document.
3. APHIS, USDA Code of Federal Regulations Title 9, Parts 101 to 123.
This is a very broad document covering animals and animal products. It
deals with aspects as diverse as the design of licensed premises, ingredient
requirements, general requirements for live and inactivated viral and
bacterial vaccines, production requirements and inspections.
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