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.