Commercial Manufacturing & Lifecycle Management
The long, unexciting part: making the same thing, the same way, for years, and proving it.
Validation is the beginning of the commercial phase, not the end of the project. A process drifts. Raw material suppliers change their own processes. Equipment is replaced. Operators turn over. The systems below exist to catch that drift before it reaches your patients.
What runs continuously
Change control
Any change to a validated process, specification, raw material source or piece of equipment is assessed for regulatory impact and agreed with you in writing before it happens. No exceptions, including for changes that look trivial.
Continued process verification
Batch data trended against validated ranges so a slow drift is visible as a trend rather than as a sudden out-of-specification result.
Annual product review
A yearly review of every commercial product covering batch performance, deviations, complaints, stability and change history, issued to you.
Deviation & CAPA management
Deviations investigated to root cause with corrective actions tracked to closure and effectiveness checked. Customers are notified of anything affecting their material.
Supply planning
Rolling forecast against reserved capacity, with agreed safety stock for products where a stock-out would stop your line.
Retention & traceability
Retained samples and full batch genealogy held for the product retest period, so any lot can be reconstructed on request.
Service commitments
What we hold ourselves to on every commercial programme.
| Commitment | Standard |
|---|---|
| Certificate of analysis issued | With every despatched lot, without being asked |
| Notification of a delay | As soon as it is known, not at the due date |
| Deviation affecting your material | Notified within 2 working days of identification |
| Regulatory query response | Acknowledged within 2 working days |
| Change to a validated process | Written customer agreement before implementation |
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