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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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GMP (Good Manufacturing Practice)
A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are:
a) Unexpected contamination of products, causing damage to health or even death.
b) Incorrect labels on containers, which could mean that patients receive the wrong medicine.
c) Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
Who GMP Guidelines - Quality Assurance of Pharmaceuticals – A compendium of guidelines and related materials – Volume 2: Good manufacturing practices and inspection
Introduction
1. WHO GMP: main principles for pharmaceutical products
Quality management
Good practices in production and quality control
Validation of manufacturing processes
Authorized person-role, functions and training
2. Good manufacturing practices: starting materials
Active pharmaceutical ingredients (bulk drug substances)
Pharmaceutical excipients
3. Good manufacturing practices: specific pharmaceutical products
Biological products
Investigational pharmaceutical products for clinical trials in humans
Herbal medicinal products
4. Inspection
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
GMP (Good Manufacturing Practice)
Regulations of the FDA and comparable non-US agencies that describe the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding a drug, to assure that such drugs meet the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to posses.
Publication Source: GAMP® Good Practice Guide: Validation of Process Control Systems
Publication Date: 2003
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