The role of GMP and ISO 22000:2018 certificates in ensuring the highest product quality and safety

Designing and launching new products in the pharmaceutical, cosmetics, and dietary supplements markets is a complex process that requires knowledge, experience, and full regulatory compliance. To optimize time and costs, your brand can use outsourcing in the CDMO (Contract Development and Manufacturing Organization) model. However, it is essential to choose a contract manufacturing partner that ensures the highest standards of quality and safety. This is evidenced by implemented systems and certificates, such as the GMP certificate (Good Manufacturing Practice), which guarantees full control over every stage of manufacturing, as well as the ISO 22000:2018 standard, which relates to food and dietary supplement safety management.

What is GMP and why is it crucial in the pharmaceutical and cosmetics industries?

The abbreviation GMP (Good Manufacturing Practice) refers to a set of standards that guarantee products are consistently manufactured and controlled in accordance with quality standards appropriate for their intended use. These guidelines cover every aspect of operations — from the cleanliness of production halls, through the qualification of material suppliers, to staff training, packaging, storage, and distribution.

In Poland, GMP principles are based on specific legal foundations:

• in the pharmaceutical industry, the Regulation of the Minister of Health of November 9, 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2022, item 1273), implementing Commission Directive 2003/94/EC, applies;
• in the cosmetics industry, the ISO 22716 standard and the guidelines set out in Regulation (EC) No 1223/2009 of the European Parliament and of the Council apply;
• in the food and supplement industry, systems based on HACCP principles and the ISO 22000:2018 standard play a key role.

Worth knowing

More restrictive GMP rules apply in the pharmaceutical industry than in the cosmetics or food industries. Importantly, in the production of dietary supplements, GMP principles do apply; however, unlike in the pharmaceutical industry, they are not subject to official certification. This makes cooperation with a partner that also applies pharmaceutical standards in the production of nutraceuticals even more important.

Who issues a GMP certificate?

A GMP certificate for medicinal products is granted by the Chief Pharmaceutical Inspector after an inspection of the facility and verification of the quality system have been carried out. In the case of facilities producing food or cosmetics, conformity assessment with the principles of good practice may also be conducted by accredited certification bodies, based on the ISO 22716 standard (cosmetics) or food safety systems (HACCP, ISO 22000).

A GMP certificate is usually granted for a specified period, after which another inspection is required. By establishing cooperation with a facility that has obtained a GMP certificate, dietary supplements, as well as other products, are manufactured under conditions that ensure the highest quality and safety for consumers, thereby increasing the brand’s credibility on the market.

Worth knowing

Laboratorium Galenowe Olsztyn (LGO), an integral part of the Eubioco group, holds a GMP certificate issued by the Chief Pharmaceutical Inspectorate, valid until 2028. For our business partners, this document is a guarantee that every stage of manufacturing is meticulously documented and monitored.

ISO 22000:2018 and HACCP — the foundations of dietary supplement safety

In the dietary supplements industry, which is subject to food law, risk management is of great importance. The fundamental system is HACCP (Hazard Analysis and Critical Control Points), which enables the identification and elimination of biological, chemical, and physical hazards. Thanks to the implementation of the HACCP system, dietary supplements are produced under conditions that guarantee high quality and production hygiene.

At Eubioco, we put quality first. In December 2024, our Laboratorium Galenowe Olsztyn obtained ISO 22000:2018 certification. ISO 22000:2018 is an international food safety management standard (FSMS – Food Safety Management System) that:

• integrates HACCP principles with the systematic management of the entire organization;
• requires continuous communication throughout the supply chain;
• ensures full traceability of every product batch;
• is subject to periodic external audits, which drives continuous process improvement.

What does this mean in practice for our business partners? Product safety at a global level and easier expansion into foreign markets.

Quality control at every stage — what does it look like at Eubioco?

At Eubioco, quality control in contract manufacturing does not end at the production line stage — the entire manufacturing process is subject to continuous verification in professional laboratories: the Physicochemical Laboratory and the Microbiological Laboratory. Continuous process monitoring relieves the B2B client of a significant portion of the legal and administrative risk associated with the potential release of a defective product batch.

Our technological facilities, used to verify the identity, purity, and concentration of substances, include, among others:

• HPLC chromatographs — for the precise determination of active substance content;
• UV/VIS and FT-NIR/IR spectrometers — used in quantitative analyses and the identification of raw materials;
• environmental chambers — for conducting accelerated and long-term stability studies;
• dissolution testing apparatus — for assessing the bioavailability of solid dosage forms (tablets, capsules).

At Eubioco, every batch of tested product samples, starting materials, packaging, and finished products receives reliable certificates of analysis. Process repeatability is further supported by dedicated IT systems, such as ARIEL and EPIONE, which reduce the risk of human error.

Why choose a certified CDMO partner?

EU regulations and rigorous quality control. In the case of cosmetics, the requirements are somewhat less restrictive, but it is still necessary to comply with specific safety norms and standards. This is precisely why the choice of a contract manufacturing partner has a direct impact on product safety and the growth of your brand. By meeting GMP, HACCP, and ISO 22000:2018 standards, the brand owner does not have to worry about costly and complex legal, quality, or infrastructure-related issues — which translates into real minimization of legal risk and cost optimization.

By choosing to cooperate with Eubioco in the end-to-end model (from idea to market debut), you gain specific business benefits, such as:

• safety and compliance — contract manufacturing in accordance with GMP, HACCP, and ISO 22000:2018 standards guarantees compliance with legal and quality requirements;
• time and cost savings — with us, you do not need to build your own technological facilities;
• experience — we stand out thanks to more than 30 years of practice in pharmaceutical manufacturing, cosmetics production, and the production of high-quality dietary supplements;
• comprehensive service — from formulation development and material selection, through process validation, to logistics, warehousing, and documentation.

Consult your project with experts

At Eubioco, we believe that quality is the result of precisely planned processes, not a matter of chance. Our mission is to improve consumers’ health by supporting the business growth of our partners — while maintaining competitive prices. With us, your brand gains quality and credibility, while legal matters and standards control remain in the hands of an experienced CDMO partner.

Are you planning to introduce your own products to the market while ensuring full cost optimization and process safety? Contact our sales department to receive an individual quotation for certified contract manufacturing and learn more about our technological facilities. We invite brand owners and manufacturers from the pharmaceutical, cosmetics, and dietary supplements industries to cooperate with us.

BIBLIOGRAPHY

1. Commission Directive 2003/94/EC of October 8, 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products (Official Journal of the EU L 262 of 14.10.2003, p. 22).
2. ISO (2018). ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain. [online]. Available at: https://www.iso.org/standard/65464.html [online access: 20.05.2026]
3. County Sanitary and Epidemiological Station in Piotrków Trybunalski. (2021). HACCP system — basic information, legal basis. [online] Available at: https://www.gov.pl/web/psse-piotrkow-trybunalski/system-haccp–podstawowe-informacje-podstawy-prawne [online access: 20.05.2026]
4. Regulation of the Minister of Health of November 9, 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2022, item 1273).