Manufacturing and Packaging
Over the years, Bertin Pharma has demonstrated its reliable capacity to produce small clinical
and commercial batches for clinical trials in GMP conditions.
Packaging types
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Blister Alu/Alu, PVC/Alu, PVC/PVDC/Alu, Aclar...
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PP tube, bag
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Aerosol
Identification
of Primary Packaging,
including the evaluation of interaction with selected formulation
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Vials
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Ampoules
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Pre-filled Syringes
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Cartridges
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Bottles
Quality control
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in-process controls
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control of batches (development, pilot, stability)
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control of clinical
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commercial batches for QP release
Documentation supplies
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.
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Related services
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Preformulation & formulation
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Equipment and Technologies
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Industrial transfer
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Quality control & dispatch of clinical supplies
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Analytical development & stability studies
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Regulatory affairs
