TRUST, WITH SOMETHING TO STAND ON
Connect the certificate to the facility. The test to the specification. The product to its batch. A clear record makes a better procurement decision.
01 / QUALIFICATION RECORDS
Review the original documents and confirm the holder, facility, scope and validity for your proposed project.
FACILITY RECORD
GMP qualification record for the named manufacturing facility.
QUALIFICATION DOSSIER
A collection of qualification and registration records for review.
Records apply to the entities, facilities and scopes they identify. They do not certify every catalog concept. FDA facility registration does not denote FDA product approval.
02 / THE QUALITY SEQUENCE
Agree the quantitative formula, product specification, producing site and testing requirements.
Keep materials, batch records, in-process checks and approved changes connected.
Review agreed results, documentation and disposition against the approved specification.
Confirm the proposed producing site and contracting entity for your specific product. Match the qualification records to that location and manufacturing scope.
Match the product reference, lot, specification, test methods, limits, units and results. Confirm which tests are covered and how the document connects to release requirements.
Describe your audit or qualification requirements in the inquiry. Document availability and any confidentiality requirements are reviewed for the project.
LET’S MAKE SOMETHING CONSIDERED
Bring a product reference, a formula or simply an idea. Start with a brief that connects your market, format and ambitions.
Discuss your project Explore the catalog