GMP Conditions for Manufacturing & Packaging
Over the years, Bertin Pharma has demonstrated its reliable capacity to produce small clinical and commercial batches for clinical trials in GMP conditions in terms of packaging and quality control.
Our Packaging Types
- blister Alu/Alu, PVC/Alu, PVC/PVDC/Alu, Aclar...
- PP tube, bag
Identification of Primary Packaging including the evaluation of interaction with selected formulation
- pre-filled Syringes
- in-process controls
- control of batches (development, pilot, stability)
- control of clinical
- commercial batches for QP release
The formulation development or production report gathers all information in order to ensure a full traceability of the process.
It constitutes the basis for regulatory writing of pharmaceutical part of the IMPD or the CTD.
A master file is generated and validated by the QA Manager before each production run, whether for a simple formulation test, a pilot batch or a clinical batch.
The complete batch records are kept for review by the Quality Assurance Manager for QP release if relevant.