Transcription of Transfer of a manufacturing process: Case study ~ Solid ...
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Transfer of a manufacturing process: Case study ~ Solid ...
Transfer of a manufacturing process : Case study ~ Solid dosage Transfer within technical operations Ian Flawn OrpanaQPharma AB, SwedenOverview of Product Product fitted into therapeutic area Purchased from big pharma Product: Highly potent Explosive Traditional production Fig. 1. Schematic of manufacturing operation Project history/setup Due diligence 1 day to technically review process Statisical process control (SPC) to determine variation Robustness of process Clarification of scope Bulk: Transferred CH to UK Bulk: UK site produced small quantity of batches Packaging outsourced to TPM Other sites involved due to regulatory demands of certain countries Selection of TPM Initial overview communication Showing show stopper issues No confidentiality agreement Explosive, potent, volumes, major process /analytical equipment, bulk volumes & packaging forms & splits Proof needed of EU GMP licence TPMs selected Knowledge from RU s people Conferences Web sitesDetailed scope for TPMT able of Contents 1 2 2 4 3 Tendering 5 4 Historical TPM Site GMP 7 5 9 6 manufacturing .
Structure of transfer protocols (2/3) ~Transfer tests acceptance criteria RU ~ Process in statistical control RU similar to SU process RU ~ Meeting release specifications
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