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What are the principles of GMP? – Good Manufacturing Practice in a nutshell

16 Mar, 2023

Have you heard of GMP quality? This term is an English acronym for Good Manufacturing Practice. This concept is widely used in the pharmaceutical and cosmetics industries, among others. Its recommendations are regulated by competent authorities and are aimed at ensuring safe and clean production. Check what GMP principles regulate in practice.

What is GMP?

Products such as medicines, cosmetics, food, and medical devices, which have a direct impact on human health, must be manufactured under reliable conditions and in a controlled quality system. The principles of GMP, i.e. Good Manufacturing Practice, are primarily aimed at ensuring efficient and productive manufacturing processes with strict hygiene control. All this to reduce the level of pollution and waste.

Good Manufacturing Practices GMP are one of the basic approaches in the production and distribution of products to the market. They cover a series of techniques that must be constantly applied at the stages of sourcing raw materials, processing, product development, manufacturing, packaging, storage, and distribution to guarantee the best product quality.

Where to look for the principles of Good Manufacturing Practice?

GMP guidelines, initially prepared by the World Health Organization (WHO), are updated and adapted in accordance with international and national legal bases. In Poland, these rules apply to three industries:

  • pharmaceutical: the legal basis is the Regulation of the Minister of Health of November 9, 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2017, item 1979);
  • cosmetics: based on ISO 22716 standard, taking into account GMP from Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products;
  • food: according to Commission Regulation (EC) No 2023/2006 of 22 December 2006 on materials and articles intended to come into contact with food.

What do the GMP requirements cover?

Good Manufacturing Practice covers issues related to, for example:

  • location and surroundings of the plant;
  • technical condition of the building, machinery, and equipment;
  • cleaning and disinfection;
  • functioning of measuring equipment;
  • supply of clean water;
  • waste control;
  • pest control;
  • employee qualifications and training;
  • personnel hygiene.

What are the basic principles of Good Manufacturing Practice GMP?

Every industry that manufactures products that affect human health must comply with GMP principles. Good Manufacturing Practice in pharmacy, food production, or cosmetics includes numerous and varied regulations. However, some of them are universal and even constitute the so-called GMP decalogue.

What do the general principles of Good Manufacturing Practice look like in a nutshell?

  1. Before starting the manufacturing process, you should familiarize yourself with all its procedures.
  2. Production standards should be strictly adhered to, and in case of doubt, ask a person with higher qualifications.
  3. It is necessary to frequently check the quality of raw materials or components.
  4. Periodic maintenance of all equipment should be carried out and the technical condition of the machines should be assessed before starting manufacturing.
  5. Hygiene practices must be implemented to minimize product contamination or soiling.
  6. Every employee must be focused on their work so as not to make a mistake.
  7. Any mistakes and irregularities should be reported to management immediately.
  8. It is necessary to take care of occupational health and safety at work and personal hygiene.
  9. The entire production process must be controlled and reported.
  10. People entrusted with given duties must take full responsibility for them.

The pharmaceutical, cosmetics, and food industries must focus on plant and employee hygiene, production efficiency, and proper maintenance of facilities and equipment. This is to minimize the occurrence of contaminants in their products as much as possible.

Want to know more about the principles of proper production? Read other articles on our blog, including the topic of differences between contract manufacturing and private label.