Quality Management System for Active pharmaceutical

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Quality Management System - integrating GMP into ISOChapter 18: TrainingPrincipleThere should be an effective mechanism for identifying training needs and taking appropriateaction to ensure that all personnel (including managers), are appropriately qualified andadequately trained.18.1 Qualification and training needs should be identified, documented and regularlyreviewed in order that additional (or repeat) training can be given in a timely manner.This is particularly important when new processes are being introduced. The use ofdocumented training modules is recommended to ensure consistency of training. Theeffectiveness of training should be evaluated.18.2 GMP awareness training should be repeated at prescribed intervals for all relevantpersonnel.18.3 Training should be recorded and individuals training records should be retained for aspecified period of time.18.4 Tasks should be assigned on the basis of qualifications, training and experience.49
Quality Management System - integrating GMP into ISOChapter 19: ServicingThis requirement is concerned with ‘after sales service’ (usually of equipment). Whereservicing is a specified requirement, documented procedures should be established to show thatservicing specifications are met.This chapter should not normally apply to API manufacturers.50
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Quality Management System for Active pharmaceutical

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