Good manufacturing practice

Standards for ensuring product quality in manufacturing

Good Manufacturing Practice (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. 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.

Key Principles

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

Quality Management

Quality management is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality management, therefore, incorporates Good Manufacturing Practice.

Sanitation and Hygiene

A high level of sanitation and hygiene should be practiced in every aspect of the manufacturing process. The detailed written procedures should be followed to ensure that the products manufactured meet the required quality standards.

Building and Facilities

The manufacturing facilities must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.

Equipment

Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.

Raw Materials

Raw materials must be stored under the appropriate conditions and in an orderly fashion to permit batch segregation and stock rotation. They must be checked to ensure that they are of the required quality before they are used in the manufacturing process.

Personnel

The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of products rely upon people. For this reason, there must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible.

Regulatory Agencies

GMP is enforced in the United States by the Food and Drug Administration (FDA), in the European Union by the European Medicines Agency (EMA), and in other countries by their respective national authorities. These agencies perform routine inspections to ensure compliance with GMP guidelines.

See Also

• Pharmaceutical industry
• Quality control
• Standard operating procedure
• Validation (drug manufacture)

External Links

• WHO GMP Guidelines
• FDA GMP Guidelines