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

GMP (from English: Good Manufacturing Practice) is a concept used, among others, in the pharmaceutical and cosmetic industries. The goal of GMP is to ensure safe and clean production. Find out what GMP principles mean in practice and what changes the recent 2024 GMP amendment introduces. From this article, you will also learn how implementing GMP can give dietary supplements a competitive advantage and increase brand credibility in the eyes of consumers.

GMP – what is it? Definition and importance of GMP in the health industry

Products such as medicines, cosmetics, food, and medical devices, which have a direct impact on human health, must be manufactured under reliable conditions and within a controlled quality system. This is why the principles of GMP – Good Manufacturing Practice – were created. This is the name given to a set of standards and procedures ensuring efficient and safe production of medicines, food, and cosmetics.

Good Manufacturing Practices (GMP) are one of the fundamental approaches in the production and distribution of products to the market. They include a series of techniques that must be consistently applied at every stage: sourcing raw materials, processing, product development, manufacturing, packaging, storage, and distribution to ensure the highest product quality. The GMP guidelines, initially developed by the World Health Organization (WHO), are updated and adjusted in line with international and national legal frameworks.

In Poland, GMP principles apply to three industries:

• pharmaceutical: legal basis – Regulation of the Minister of Health of 9 November 2015 on Good Manufacturing Practice requirements (Journal of Laws 2017, item 1979);
• cosmetic: based on ISO 22716 with inclusion of 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.

Good to know: In the pharmaceutical industry, GMP rules are more stringent than in the cosmetic or food industries.

Who issues the GMP certificate?

The GMP certificate is issued by the Chief Pharmaceutical Inspector after an on-site inspection and verification of the facility’s quality system. For plants producing food or cosmetics, GMP quality control can also be carried out by accredited certification bodies based on ISO 22716 (cosmetics) or food systems (HACCP, ISO 22000).

The GMP certificate is usually valid for 3 years. An example of a company holding a GMP certificate is Laboratorium Galenowe Olsztyn, part of the Eubioco group. By partnering with a facility certified under GMP, dietary supplements and other products are manufactured under conditions that ensure the highest quality and safety for consumers, enhancing the brand’s credibility in the market.

Consequences of non-compliance with GMP

Failure to comply with GMP rules may result in:

• financial penalties,
• loss of GMP certificate,
• product recalls,
• civil and reputational liability.

GMP vs HACCP – differences

Besides GMP, the second most important and mandatory system in dietary supplement production is HACCP (Hazard Analysis and Critical Control Point System). To learn more about HACCP certification, check out the article: Types of dietary supplement certificates: GMP, HACCP.

Main legal changes (2024–2025)

The 2024 amendment to the Regulation of the Minister of Health on Good Manufacturing Practice requirements introduced significant changes for manufacturers of medicines and clinical trial products.

The 2024 GMP amendment introduced:

• GMP Annex 21, which concerns the import of medicinal products from third countries and imposes an obligation to maintain full GMP documentation and verify substance quality within the EU. This is particularly important for manufacturers sourcing raw materials from outside the European Union;
• GMP Annex 7, which concerns clinical trial products, including plant-based products, and introduces a requirement for detailed quality control of raw materials, their origin, storage, and safety.

The 2024 GMP amendment and dietary supplements – are the new rules mandatory for manufacturers?

For dietary supplement manufacturers, GMP Annex 21 and Annex 7 are not formally mandatory. However, many companies follow the new guidelines in the production of phytosupplements or in export contracts to ensure the highest standards of quality and safety.

New supplement regulations 2025

The 2024 amendment to the Regulation of the Minister of Health on Good Manufacturing Practice requirements also introduced changes regarding supplement ingredients and dosages:

• A new limit on vitamin B6 in dietary supplements – since long-term intake of high doses of vitamin B6 has been linked to an increased risk of peripheral neuropathy and neurological disorders, the European Food Safety Authority (EFSA) lowered the tolerable upper intake level (UL) for adults to 12 mg/day;
• New forms of iron (such as ferric pyrophosphate) have been approved as mineral ingredients in supplements. As a result, supplement manufacturers can develop more innovative products, e.g., with better bioavailability and gentler effects on the stomach.

10 basic GMP rules – manufacturer’s decalogue

Every industry producing goods that affect human health must comply with GMP rules. Good Manufacturing Practice in pharmaceuticals, food, or cosmetics involves numerous and varied regulations. However, some of them are universal and are often referred to as the “GMP decalogue.”

Here are the most important GMP (Good Manufacturing Practice) rules in a nutshell:

• Before starting the manufacturing process, familiarize yourself with all its procedures.
• Strictly follow production standards and, in case of doubt, consult higher-qualified staff.
• Frequently check the quality of raw materials or components.
• Carry out regular maintenance of all equipment and assess the technical condition of machines before production.
• Implement hygiene practices to minimize product contamination.
• Each employee must remain focused on their tasks to avoid errors.
• Report any mistakes or irregularities to management immediately.
• Ensure workplace safety (OHS) and personal hygiene.
• The entire production process must be controlled and documented.
• Individuals assigned responsibilities must take full accountability for them.
• The pharmaceutical, cosmetic, and food industries must focus on facility and employee hygiene, production efficiency, and proper maintenance of facilities and equipment to minimize contamination in their products.

To learn even more about GMP principles, check our article: 10 principles of Good Manufacturing Practice (GMP).

Summary – how to prepare your company for changes?

GMP (Good Manufacturing Practice) is the foundation of legal and safe dietary supplement production in the European Union and in Poland. By following GMP rules, manufacturers (and consumers) can be assured that a given product is consistent in quality, meets specifications, and is free from contamination.

Failure to comply with GMP requirements can result in serious consequences such as product recalls, financial penalties, loss of customer trust, and even withdrawal of the production facility’s license. Such problems can be avoided by using contract manufacturing of dietary supplements.

In this cooperation model, the external manufacturer takes responsibility for GMP compliance, quality control, and complete production documentation. This allows the company launching the product to focus on marketing and sales, while being sure the production process fully complies with applicable standards and laws, including the new 2025 supplement regulations. If you want to learn more about proper production principles, read other articles on our blog, including the one on differences between contract manufacturing and private label.

GMP (Good Manufacturing Practice) – frequently asked questions

I. What is GMP (Good Manufacturing Practice)?

GMP (Good Manufacturing Practice) is a set of standards and procedures ensuring the safe production of medicines, food, and cosmetics.

II. What did the 2024 amendment to the Regulation of the Minister of Health on Good Manufacturing Practice requirements change?

The amendment introduced Annex 21 (import of medicines) and Annex 7 (clinical trial products), emphasizing, among others, the obligation of a quality system and detailed documentation.

III. What’s new for dietary supplements?

New forms of iron have been approved, the daily vitamin B6 limit reduced to 6 mg, and stricter health claims announced.

IV. Who issues the GMP certificate?

The GMP certificate is issued by the Chief Pharmaceutical Inspector after inspection and verification of the facility’s quality system.

V. Does GMP apply to all manufacturers?

Yes, GMP applies to all manufacturers, but the scope of requirements varies: pharmaceuticals have stricter rules than food and cosmetics.

VI. What are the consequences of non-compliance with GMP?

Failure to comply with GMP may result in financial penalties, loss of the certificate, product recalls, and civil liability.

VII. Can supplements have a GMP certificate?

No, supplements themselves do not hold a GMP certificate; it is the production facility that can obtain such a certificate, increasing brand credibility.

VIII. How long is a GMP certificate valid?

The GMP certificate is usually granted for 3 years and then requires regular audits and re-certification.