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Project planning in GMP environment

Project planning in GMP environment. Joanna Przysowa Project Manager. IPG Introduction. European Regulatory and Project Management MA Holder Responsibilities of MA holder management Dossier due diligence and updating Facility GMP inspection preparation

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Project planning in GMP environment

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  1. Project planning in GMP environment Joanna Przysowa Project Manager

  2. IPG Introduction • European Regulatory and Project Management • MA Holder • Responsibilities of MA holder management • Dossier due diligence and updating • Facility GMP inspection preparation • Technical transfer of product to new/trigger facility • Regulatory affairs activities and strategy • Pharmacovigilanceand medical reporting • Contractual requirements and negotiations • Project and budget management • Sales and supply • Sourcing and negotiating licenses/dossiers deals

  3. Major issues • Understanding differences between cGMP and local GMP rules • European regulatory requirements • Communication with client/investor • Change control and project timeline • Complexity of the projects

  4. Case study Production of sterile injection antibiotics in newly GMP approved manufacturing site in China to supply the European market • Technical transfer & preparation for validation batches • Site variation to MHRA • Control of manufacturing and product release • Change control/GMP compliance

  5. Case study 1: Technical transfer & preparation for validation batches • Upgrade of MoA to Eu. Ph. standard – preparation and method transfer • Scale up of batch sizes • Change of primary packaging specifications (size, type, supplier) • Change of API supplier • Stability studies to be mirrored in UK • Zone 4 stability Result: product samples and QC work exceeded initial expectactions

  6. Case study 2: Site variation to MHRA • Variations submitted to MHRA • all changes applied for validation batches • manufacturing site • site release & QC laboratory • artwork & leaflets • Validation protocols and reports • Stability data

  7. Case study 3: Change control/GMP compliance • Differences in Chinese/European GMP • Adhere to Technical Agreement • Old habits & parallel production for internal market • Change control on both sides (Packaging, campaign production, MF, production line alternation & GMP certification)

  8. Case study 4: Control of manufacturing and product release Daily supervision and communication • Coordination of artwork • Control change at both ends • Supply chain, packaging and logistic (packaging optimisation) • Temperature control • CoA & CoR • Product repacking & re-labelling

  9. Cooperation & • QC tests and retention storage for commercial release • Qualified Person • Protocols and methods • Technical advice & problem solving • Flexible, fast &professional

  10. Thank you for your attention Ice Pharma Group

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