10 principles of Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a set of standards and guidelines developed to ensure high quality in the production process. Where can you find current regulations on Good Manufacturing Practice? How do GMP requirements differ in the pharmaceutical and cosmetic industries? Discover the 10 most important GMP principles.

Key takeaways:

• Good Manufacturing Practice (GMP) is a set of guidelines and standards regulating how products should be produced and controlled.
• The implementation of GMP principles is particularly important in the pharmaceutical industry.
• By adhering to the most important GMP principles, it is possible to ensure high product quality and take care of its safety for the consumer.

GMP Basics – What Is It? What Is GMP Based On?

Good Manufacturing Practice (GMP) covers various aspects of production, from raw materials, through premises and equipment, to hygiene and staff training. GMP implementation is particularly important in the pharmaceutical industry — it is an industry where even the slightest deviation from standards could have serious consequences.

GMP – Definition and Fundamental GMP Principles

What does GMP mean? The acronym comes from English (Good Manufacturing Practice). GMP (Good Manufacturing Practice) is a set of standards and guidelines for pharmaceutical, cosmetic, and food production companies. The main goal of GMP is to ensure the high quality of food, medicines, dietary supplements, and cosmetics so that they are safe for consumers.

Fundamental GMP principles are based on several key pillars, which include:

• quality control of raw materials used in production — all raw materials must meet specific quality standards;
• GMP documentation system — every activity in the production process must be properly documented;
• staff training — every employee involved in the production processes must be properly trained and competent;
• quality management — production processes should be continuously monitored, controlled, and improved;
• waste management — proper segregation, storage, and disposal of waste are necessary.

Good Manufacturing Practice (GMP) – Documentation System

The basis of GMP is documentation. All production processes and control activities must be recorded to enable tracing the production process from start to finish.

HACCP, GHP, GMP – What Is It?

Equally important as GMP implementation is the integration of GMP principles with other systems, such as Good Hygiene Practice (GHP). GHP and GMP are an important element of the HACCP system (Hazard Analysis and Critical Control Points), i.e., a comprehensive approach to the quality and safety of production processes.

Good Manufacturing Practice – Legal Basis

GMP principles are strictly regulated by law. This is due to the fact that products that do not meet appropriate quality standards could pose a serious threat to consumer health.

Current Legal Requirements in Poland – Where to Find GMP Principles?

Current regulations on Good Manufacturing Practice can be found in legal acts and regulations of the Ministry of Health and the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. In Poland, these principles apply to three industries: pharmaceutical, cosmetic, and food.

Good Manufacturing Practice – Requirements for Individual Industries May Be Specific

Good Manufacturing Practice is particularly important in the context of the pharmaceutical and cosmetic industries. However, regulations in these two industries may differ:

• in the pharmaceutical industry, 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);
• in the cosmetic industry, GMP principles are applied in accordance with ISO 22716, 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.

Good Manufacturing Practice – International Requirements

For companies operating in foreign markets, international GMP standards, e.g., those prepared by the World Health Organization (WHO), are also important. The European Commission and the European Medicines Agency (EMA) are also involved in developing guidelines for Good Manufacturing Practice, regulatory requirements, and international standards.

GMP Requirements in Pharmacy vs. Good Manufacturing Practice for Cosmetics

GMP requirements for cosmetics and dietary supplements are less restrictive compared to medicines.

Good Manufacturing Practice – Pharmacy

Good Manufacturing Practice (GMP) in the pharmaceutical industry places particular emphasis on the validation of production processes. Quality control is also important, which includes, among other things, drug stability studies and microbiological purity tests. Documentation must be detailed, complete, and compliant with the rigorous requirements of the Ministry of Health and other regulatory bodies. Read also our article on the certification of dietary supplements.

Good Manufacturing Practice – Cosmetics

In the cosmetic industry, GMP focuses on controlling the quality of raw materials and final products and adhering to hygiene during production. Documentation must include raw material specifications, quality control protocols, and reports from conducted tests, but regulations are less restrictive compared to medicines.

Good Manufacturing Practice – The 10 Most Important Rules

Below you will find the 10 most important GMP rules that form the foundation of Good Manufacturing Practice. This is the so-called GMP Decalogue, proposed by the Polish Institute of Food and Nutrition.
Good Manufacturing Practice – The 10 Most Important GMP Rules:

• Before starting work, make sure you know all procedures and have the required instructions at your workstation.
• Always follow the instructions precisely. If you have any doubts, consult your supervisor or refer to the appropriate documentation.
• Before starting work, verify that you are dealing with the correct raw material or intermediate product.
• Assess the technical condition of equipment and machinery before use.
• Work in a way that minimizes the risk of product contamination.
• Be attentive, stay focused, and avoid mistakes.
• Report any irregularities immediately to your supervisor.
• Maintain personal hygiene and cleanliness in the workplace.
• Accurately and consistently record all data related to the process.
• Always take responsibility for your actions.

Summary

The concept of Good Manufacturing Practice (GMP) is applied in the production of food, medicines, dietary supplements, and cosmetics. GMP principles are updated and adapted to comply with international and national legal frameworks. The goal of Good Manufacturing Practice is to ensure the highest quality and safety for consumers.

Frequently Asked Questions (FAQ)

What are the key differences in GMP requirements for the production of medicines, supplements, and cosmetics?

In the pharmaceutical industry, GMP places particular emphasis on validating production processes and minimizing risks to patient health and safety. Strict quality control and detailed documentation are required, in compliance with regulations set by the Ministry of Health and other regulatory bodies. While GMP requirements for dietary supplements and cosmetics are also stringent, they are not as complex as those for medicines.

How often should internal GMP system audits be conducted?

Regular audits and inspections, both internal and conducted by external certification bodies, are necessary to verify GMP compliance. Internal GMP system audits should be performed at least once a year in each department. In cases of significant non-compliance, audits may be conducted more frequently, such as every six months or quarterly.

What should a basic GMP documentation system include in our company?

A basic GMP documentation system should include detailed descriptions of all production procedures. GMP documentation should also contain all information related to raw material and product quality control. In pharmaceutical companies, validation documentation for processes and equipment is also essential.

BIBLIOGRAPHY

1. Regulation of the Minister of Health of November 9, 2015, on Good Manufacturing Practice requirements. Journal of Laws 2015, item 1979.
2. Regulation (EC) No 1223/2009 of the European Parliament and the Council of November 30, 2009, on cosmetic products. Official Journal of the EU L.2009.342.59.
3. Morkis, G. (2006). The level of implementation of GHP, GMP, and HACCP in the food industry. Food, Polish Society of Food Technologists 3 (48).
4. Provincial Sanitary and Epidemiological Station in Katowice – Gov.pl Portal. (2025). Good Manufacturing Practice (GMP) and Good Hygiene Practice (GHP) [online]. Available at: https://www.gov.pl/web/wsse-katowice/gmpghp [accessed online: 17.01.2025].