QUALITY & COMPLIANCE

Quality evidence should follow the product, the batch and the claim

We connect approved materials, controlled production, finished-product release and traceability to the specification agreed for each project.

The quality system behind every batch

Supplier and material approval

Identity, specification, certificate and risk information are reviewed before use according to the material and project.

Pre-production control

Formula, bill of materials, artwork version, packaging and production instructions are checked before the batch starts.

In-process control

Relevant process parameters and physical attributes are monitored according to the dosage form.

Finished-product release

Testing and acceptance criteria are defined in the agreed specification and release plan.

Retain and traceability

Batch records and retain samples support trace-back, trace-forward and investigation activities.

Deviation and corrective action

Unexpected results are documented, assessed and handled through the applicable quality process.

Testing & COA

Testing plans differ by product and market. Depending on the agreed specification, release or verification may cover:

Identity

Physical properties

Microbiology​

Selected nutrients or actives

Contaminants

Oxidation indicators​

Packaging integrity​

Other project-specific criteria​

Audit and document requests

We can provide certificate information, audit arrangements and more.