Good Manufacturing Practice (GMP)

GMP refers to the Good Manufacturing Practice regulations enforced by the FDA and its main purpose is to prevent harm from occurring to the end user. The GMP is the minimum requirement for drug production, which provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. For both patients and governments, the poor-quality drug is a disaster. Therefore, the pharmaceutical industry has a responsibility to ensure their drugs meet the internationally recognized GMP standards. Meanwhile, GMP can also help boost pharmaceutical export opportunities and minimize risks, saves costs, and improve the standard of drugs worldwide.

Fig.1 Good Manufacturing Practice (GMP) production

Introduction to Good Manufacturing Practice (GMP)

Currently, many countries have formulated their own GMP based on the GMP guidelines established by the World Health Organization (WHO). The most frequently referenced GMP is the US cGMP (current GMP), the International Conference on Harmonization (ICH) Q7 GMP guide for active pharmaceutical ingredients (API), the European Union guide to GMP for medicinal products, and the WHO GMP (2003). In the field of drug development, small errors can lead to serious medical consequences. The GMP is particularly important for drug production and helps to reduce several common errors such as incorrect labeling, inconsistent dosages forms, and drug contamination. Failure to comply with GMP regulations can lead to product recalls, heavy fines, and even imprisonment. The FDA inspects pharmaceutical manufacturing facilities around the world, including those that produce active ingredients and finished products. The FDA also relies on reports from the public and industry about potentially defective drugs, and the help can help identify sites for which an inspection or investigation is needed.

The guidelines of GMP in drug production

The guidelines of GMP are high-level details, covering initial materials, health, and safety training for staff and equipment used. It is important to note that GMP standards are not prescriptive instructions on how to manufacture products, and they are flexible and open-ended allowing each manufacturer to implement them to suit their manufacturing needs. The main guidelines are listed below:

• Operators should be trained to carry out and record the manufacturing processes.
• Manufacturing facilities must be cleaned and high standards of hygiene from procurement to product.
• Records should be made during manufacture and quality control.
• Manufacturing processes must be clearly recorded (called SOP) and each stage must be validated and optimized.
• Manufacturing facility design, operating principles, and environmental conditions must be controlled to prevent Cross-contamination.
• The quality and amount of drug product and the distribution of each batch must be documented.
• Any deviation from the SOP must be investigated and documented, and a system can be used to recall any lot from sale or supply.
• The production and distribution of the drugs must minimize any risk to their quality.

References

1. Guide to Good Manufacturing Practice for Medicinal Products Part I.
2. Reis, C., Gouveia, B., Rijo, P. and Gonçalo, T., 2015. Good manufacturing practices for medicinal products for human use. Journal of Pharmacy and Bioallied Sciences, 7(2), p.87.

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