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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