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.
Quality systems
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.
Regulatory approach
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:
WHO-GMP certification is not WHO product prequalification. They are different assessments, of different things, by different processes.
Construction to EU-GMP standards is not EU-GMP certification. A building can be designed to a standard without having been assessed against it.
Exporting to a market is not approval by that market. Shipment history and regulatory status are separate facts.
Certificates, licence numbers, site scopes, validity dates and inspection histories are provided in a credential appendix to counterparties who need to verify them. If a claim is not currently documented, it does not appear on this website — which is a more useful signal about how we will behave in a supply relationship than any adjective would be.
Safety & continuity
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.