Quality in the selection of the contract manufacturer of Dietary Supplements

Ewelina Dziedzic-Trojan
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Quality in the selection of the contract manufacturer of Dietary Supplements

What you will learn after reading this article

- Dietary supplements are food — they are subject to HACCP and GIS supervision, but real quality and repeatability are only ensured by advanced quality management systems (FSMS/GFSI).

- A certified contract manufacturer (and not just “implemented”) guarantees control of the entire process, documentation, continuous improvement and greater product safety.

- Certifications (FSMS, Halal, Kosher, FDA) increase brand credibility, facilitate cooperation with retail chains and export expansion.

- A responsible partner invests in sustainability and ISO standards (environment, employees, laboratories), which builds long-term trust and brand stability.

What you will learn after reading this article

- Dietary supplements are food — they are subject to HACCP and GIS supervision, but real quality and repeatability are only ensured by advanced quality management systems (FSMS/GFSI).

- A certified contract manufacturer (and not just “implemented”) guarantees control of the entire process, documentation, continuous improvement and greater product safety.

- Certifications (FSMS, Halal, Kosher, FDA) increase brand credibility, facilitate cooperation with retail chains and export expansion.

- A responsible partner invests in sustainability and ISO standards (environment, employees, laboratories), which builds long-term trust and brand stability.

The market of dietary supplements

Statistical data show that the majority of Poles declare regular use of dietary supplements and the dynamics is increasing. Supplements are not a medicinal product, but food and are subject to the safety rules described in the Food Law. High-quality dietary supplements can become an excellent complement to health-promoting prevention - and so, according to their definition, supplement the patient's diet

Quality as the foundation of safety and added value

The supervision of supplements is exercised by the Chief Sanitary Inspector, and each entity dealing with food must comply with HACCP, which is the absolute minimum in terms of food safety. This is required under Regulation 852/2004 on the hygiene of foodstuffs. It is a system that oversees food safety but not specific quality and repeatability.

Quality as the foundation of safety

Today's consumers are more aware, they have access to information online, they are curious but also demanding. The answer to the increased demand for high quality products is FSMS — Food Safety Managment System — Food Quality Management System. They were created at the initiative of GFSI, a coalition within the Consumer Goods Forum (CGF) bringing together retailers and brand owners. Certification to GFSI standards is not legally required, but desired by companies from their suppliers to demonstrate a commitment to food safety. This is a market standard.

The quality management system is the harmonization of regulations and the guarantee that every stage - from the acceptance of the raw material, through the production, to the final product - is subject to control, validation and complete documentation and the processes are constantly improved. Our own laboratory and quality department allow for ongoing verification of parameters and quick response to potential inconsistencies. In this sense, quality is not a one-time action, but a coherent process that protects the health of consumers and builds trust in the brand.

The more certificates the better

A good contract manufacturer is a manufacturer certified, not just “implemented” in the system. Certification is the validation of the system through verification by an independent certification body, i.e. a third party. It is also crucial to select the appropriate certification body — a recognized, international body has a strict auditing regime, and the certificate issued by it adds prestige to the certified organization. When receiving such a certificate from our potential supplier, you should pay attention to whether the scope of verification (scope) have been covered by all or particularly interesting production processes.

Certificate Europharma Alliance

What tangible benefits does the customer get from FSMS certification? This is understanding of needs, commitment, appropriate planning taking into account risks and opportunities, attention to documentation, care for employees, readiness to respond in emergency situations, supervision of threats. FSMS is continuous monitoring, measurement, analysis and feedback and process improvement. All this translates into consumer satisfaction and increased sales opportunities - especially in the context of cooperation with retail chains and export expansion. In the case of export, it is necessary to bear in mind the requirements specific to the given markets, e.g. Halal and Kosher religious certifications that meet specific needs. For the US market, mandatory FDA registration should be included.

Balance and responsibility

A contractual partner who is aware of his role goes beyond the basic legal requirements. The motto of the 21st century has become balance and responsibility. The sustainable development of the organization is confirmed by concrete implementations and certifications of ISO standards, including Care for the environment through the implementation of the ISO 14001 standard, which allows the organization to minimize its negative impact on the environment and regulates waste management. The concern for the safety of employees within the framework of ISO 45001 or the reliability of laboratory test results in accordance with ISO 17025 show that the company thinks long-term and responsibly. Certification and maintenance of the system is a voluntary cost for the company but also an investment in development. A good contract partner is a responsible and committed manufacturer who treats quality as a process and safety as a real value. It is a choice that translates into brand stability, consumer confidence and the possibility of long-term development.

Balance and responsibility

Bibliography
  1. https://www.pharmaalliance.eu/en/quality
  2. Dziedzic-Trojan, Ewelina. 2025. "How to choose a good contract partner for supplement production." Article based on an original presentation. Europharma Alliance.

Hello and welcome!

I graduated in Pharmacy at the Medical University of Wroclaw. Since 2014, I have been involved in the food supplement industry. With my knowledge and commitment, I support the Business Development Department in introducing new products to the market.
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