Quality
Built for regulated markets. Described precisely.
Our facilities are designed and operated in accordance with current Good Manufacturing Practice principles and/or other applicable requirements, under quality systems built to support products intended for regulated markets.
What the quality system governs.
Documentation & data integrity
Batch records, specifications, method validation reports and change history are maintained as a controlled documentation set. Data integrity practice governs how records are created, reviewed and retained.
Change & deviation control
Formal change control and deviation management, with investigation, root-cause analysis and corrective action recorded and closed rather than noted.
Supplier qualification
Material suppliers are qualified formally, with traceability maintained from incoming raw material through to finished product release.
In-process & release testing
In-process control through the manufacturing sequence, and finished product testing against specification prior to release.
Stability
Stability programmes under defined storage conditions, with reporting appropriate to the intended market and shelf-life claim.
Validation
Process, cleaning and analytical method validation, with records maintained as part of the technical file supporting customer filings.
Why this page is careful with words.
Pharmaceutical credentials are easy to blur and consequential to overstate. We use a simple rule: describe what the operation is built and run to do, and state a specific certification, registration or inspection outcome only where a current document supports that exact description.
Three distinctions we hold to, because they are routinely collapsed in this industry and a procurement team will notice:
Certification is not prequalification
WHO-GMP certification and WHO product prequalification are different assessments, of different things, by different processes.
Built to a standard is not certified to it
A facility can be designed and constructed to EU-GMP standards without having been assessed against them.
Exporting is not approval
Shipment history and regulatory status are separate facts. One does not establish the other.
The obligations that outlast a shipment.
Pharmacovigilance
Adverse-event collection, assessment and reporting, with defined responsibilities and routes appropriate to each market of supply.
Complaints & investigation
Quality complaints logged, investigated to root cause and closed within defined timeframes, with outcomes reported to the customer.
Recall readiness
Traceability sufficient to identify and retrieve a batch, with recall procedures tested rather than merely documented.
Next step
Need to verify something before you proceed?
That is the correct instinct, and we would rather you did it early. Ask us for the credential appendix.