Symbiosis Pharmaceutical Services offers QP certification and confirmation services across aseptic fill and finish and beyond. Our quality experts release clinical batches under our MHRA IMP license and licensed products under a commercial manufacturer/importer’s license.
The use of a Qualified Person (QP) to review and confirm compliance of each and every GMP batch for clinical and commercial use is a regulatory requirement when releasing your product into European markets. The QP can provide a QP Confirmation, confirming that the manufacturer’s activities have been performed suitably, or a QP Certification, certifying that the batch of medicine is suitable for use. As the QP must have a full understanding of the manufacturer’s methods and quality system, engaging external QP support can take time for them to come up to speed.
Acting as the advocate for the regulators, and ultimately the patient, our QPs collaborate with our QA team to ensure that GMP standards are met and maintained in every single batch. While they are professionally independent, the QPs embedded within Symbiosis are fully engaged with our quality systems and processes allowing manufactured batches to be reviewed, confirmed and certified as quickly as possible.
We can also support activities such as shelf life extension.
Symbiosis has you covered – manufacturing to GMP regulations, we provide QP GMP confirmation and certification supporting your product release to clinic, market or direct to you for onward processing.
Several QPs are likely to contribute to the confirmation and certification of any batch of product. Symbiosis can support QP release across the following processes:
| Clinical Trial Manufacture | Commercial Manufacture | |
|---|---|---|
| Clinical Trial GMP in the destination of the trial | ||
| Manufacturing Authorisations for the sites involved | ||
| Clinical Trial Application | ||
| Investigational Medicinal Product dossier | ||
| Product Specification File | ||
| Commercial GMP in the destination market | ||
| Manufacturing Authorisations for the sites involved | ||
| Product Licence |
