Good Manufacturing Practice GMP

Good Manufacturing Practices, known internationally by the acronym GMP, are regulations that describe a set of principles and procedures covering the methods, equipment, facilities, and controls required for producing human and veterinary products, medical devices and processed food to the required quality. They are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use. In the United States (U.S.), the Food and Drug Administration (FDA) has issued these regulations as the minimum requirements where they are called "current" Good Manufacturing regulations (cGMP), to emphasize that the expectations are dynamic [B-47]. Most countries have their own GMPs for drug and medical device manufacturers. GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to GMP are safe, properly identified, of the correct strength, pure, and of high quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.

At a generic level the GMPs adopted by most nations are very similar, with the set of basic requirements below.

• Equipment and facilities to be properly designed, maintained, and cleaned.

• Standard Operating Procedures (SOPs) be written, approved and followed.

• An independent Quality unit be established (like Quality Control and/or Quality Assurance).

• Both personnel and management should be well trained.

Managers need to be aware of the training requirements, which are quite specific. For instance in the EU the training requirements are as follows.

• The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.

• Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programs should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.

• Personnel working in areas where contamination is a hazard e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled should be given specific training.

• Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.

• The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.

GMP contains ten principles that introduce employees to critical behaviours established by FDA and industry leaders to maintain good manufacturing practices in plants.

The ten GMP principles

1. Writing procedures

2. Following written procedures

3. Documenting for traceability

4. Designing facilities and equipment

5. Maintaining facilities and equipment

6. Validating work

7. Job competence

8. Cleanliness

9. Component control

10. Auditing for compliance

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