上海cmc培訓(xùn)ensuringdrugqualityforpublichealththeimplementation-資料下載頁(yè)
2025-01-20 01:32本頁(yè)面
【正文】 eaucratic exercise to satisfy FDA REQUIRE ORIGINAL RECORDS as the task (operation) is being performed, not a recopying of the original. Data must not be altered – Production: batch records – QC: testing records Violations: Serious Consequences 35 Documentation ? All SOP (especially production batch record) should be in sufficient detail for the operator to carry out the task in a consistent manner ? Changes in SOP must be reviewed and approved by QA 36 Material Management 37 Material Controls ? Raw materials ? Intermediates ? Components ? API ? Manufacturing materials – ., sterilizing filters ? Facility materials – ., HEPA filters 38 ICH Q7A: Materials Management ? Manufacturers of intermediates and/or API should have a system for evaluating the suppliers of critical material ? Materials should be purchased against an agreed specification, from a suppliers, approved by the quality unit(s) ? If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer. ? Changing the source of supply of critical raw materials should be treated according to Section 13, Change Control. 39 Equipment Management 40 Qualification of Equipment Issues especially pertain to: ? Adequate IQ, OQ, PQ ? Instruction and training of operation for use of equipment ? Establish regular maintenance, calibration and maintain documentation of these activities 41 Supply Chain Management 42 Supply Chain Management ? Identify critical control points (areas) and implement adequate controls to ensure integrity of the supply of raw materials, ponent, excipients, API, drug product through procurement, manufacturing and distribution. – Tamper resistant – Serialization – testing 43 Regulatory Actions for nonGMP pliant firms ? Warning Letters ? Withholding Approval ? Import Detentions and Alerts ? Seizures ? Injunctions ? Prosecutions IMPACT: Product NOT suitable for use. 44 Thank You Brenda Uratani
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