Quality control systems

Quality control in food supplement manufacturing

Contract manufacturing of food supplements requires appropriate supervision of raw materials, technological processes, hygiene conditions and production documentation. Individual activities should be carried out according to established procedures that help reduce the risk of non-conformities and maintain consistency between production batches.

The systems implemented at Regnum Milk cover the design and production of powdered and capsule food supplements. The scope of the ISO 9001:2015 certification also includes the packaging of food supplements. The certification scope therefore corresponds to the services provided by our facility to companies outsourcing the manufacture of their products.

Supervision of the manufacturing process

Quality control is not limited to checking the finished product. It also includes activities performed before production begins and throughout the manufacturing process. These may include verifying the conformity of raw materials with the relevant documentation, correct batch identification, supervision of process parameters and control of the packaging process.

The scope of controls and testing is determined according to the type of food supplement, its composition, dosage form and agreed product specification. This allows the requirements to be adapted to a specific project instead of applying an identical control scheme to every product.

Documentation and batch traceability

Properly maintained documentation makes it possible to link a finished product batch to the raw materials used and the course of the manufacturing process. This is important both for ongoing quality control and for investigating any potential non-conformity.

The quality management system also defines how deviations are documented, their causes analysed and appropriate actions implemented. This allows manufacturing processes to be systematically evaluated and improved.

Frequently asked questions

Which quality systems are used by Regnum Milk?

Regnum Milk holds certified ISO 9001:2015 and ISO 22000:2018 management systems, as well as a HACCP system compliant with the Codex Alimentarius principles. Our production processes also follow GMP and GHP principles.

What is covered by the Regnum Milk certificates?

The certificates cover the design and production of powdered and capsule food supplements, including the packaging methods specified in the documents. The scope of ISO 9001:2015 additionally includes the packaging of food supplements. The complete scope is stated in the certificates available on this page.

Do the certificates apply to individual food supplements?

The certificates apply to the management systems and processes used at the manufacturing facility, rather than to the effectiveness of an individual food supplement. The requirements for each product are determined according to its composition, dosage form and agreed specification.

How is the scope of product controls and testing determined?

The scope of controls and testing depends on the type of raw materials, dosage form, agreed product specification and risk assessment. Detailed requirements are established individually for each manufacturing project.

Is production batch traceability maintained?

The manufacturing process is documented in a way that makes it possible to link a finished product batch to the raw materials used and the individual stages of production. This supports production control and the investigation of any potential non-conformities.

Are the certificates available for inspection?

Yes. The current ISO 22000:2018, HACCP in accordance with the Codex Alimentarius and ISO 9001:2015 certificates are available on this page.