Basic Principles of GMP SelfInspection and quality audits
Basic Principles of GMP Self-Inspection and quality audits Module 7 | January 2006 Slide 1 of 17 STOP
Self-Inspection Objectives l To identify the role of self-inspection in the quality management system l To review the way in which a self-inspection programme should be carried out l To discuss what to inspect and verify in a company’s selfinspection system Module 7 | January 2006 Slide 2 of 17 STOP
Self-Inspection Principle (1) l Purpose of self-inspection is to evaluate whether a company’s operations remain compliant with GMP l Assists in ensuring quality improvement l The programme should ä cover all aspects of production and quality control ä be designed to detect shortcomings in the implementation of GMP 8. 1 ä recommend corrective actions ä set a timetable for corrective action to be completed Module 7 | January 2006 Slide 3 of 17 STOP
Self-Inspection Principle (2) l Performed routinely l Also on special occasions such as ä Recalls ä Repeated rejections ä When a GMP inspection is announced by the national drug regulatory authority 8. 1 Module 7 | January 2006 Slide 4 of 17 STOP
Self-Inspection Principle (3) l Self-inspection team should consist of personnel who: ä can evaluate the situation objectively ä have no conflict of interest, have no revenge in mind ä should have experience as observers of a self-inspection team before becoming a team member ä can be lead self-inspector with experience as team member l Procedure should be documented l Effective follow-up programme 8. 1 Module 7 | January 2006 Slide 5 of 17 STOP
Self-Inspection 1. Self-inspection - informal (daily) 2. Self-inspection - formal (quarterly) 3. QC - Internal (half-yearly) Module 7 | January 2006 Slide 6 of 17 Immediate correction Improve systems Confirm compliance STOP
Self-Inspection Items for Self-Inspection (1) l Written instructions provide minimum and uniform standard l Covering all aspects of GMP: ä personnel ä premises including personnel facilities ä maintenance of buildings and equipment ä storage of starting materials and finished products ä equipment ä production and in-process controls ä quality control 8. 2 Module 7 | January 2006 Slide 7 of 17 STOP
Self-Inspection Items for Self-Inspection (2) ä documentation ä sanitation and hygiene ä validation and revalidation programmes ä calibration of instruments or measurement systems ä recall procedures ä complaints management ä labels control ä results of previous self-inspections and any corrective steps taken Module 7 | January 2006 Slide 8 of 17 STOP 8. 2
Self-Inspection The Self-Inspection Team l Team appointed by management, with: ä authority ä sufficient experience ä may be from inside or outside the company ä experts in their own field ä familiar with GMP l Frequency should be at least once a year ä May depend on company requirements ä Size of the company and activities Module 7 | January 2006 Slide 9 of 17 STOP 8. 3, 8. 4
Self-Inspection Carrying Out a Self-Inspection l Report prepared at completion of inspection, including: ä results ä evaluation ä conclusions ä recommended corrective measures l Follow-up action ä Effective follow-up programme ä Company management to evaluate both the report and corrective actions Module 7 | January 2006 Slide 10 of 17 STOP 8. 5, 8. 6
Self-Inspection Quality Audit l A quality audit is an examination of all or part of quality system with specific aim of improving it l Usually conducted by outside experts or team appointed by management l Useful to supplement self-inspection programme with quality audits l May be extended to suppliers and contractors 8. 7 Module 7 | January 2006 Slide 11 of 17 STOP
Self-Inspection Suppliers’ audits and approvals l QC department should have responsibility together with other relevant departments for approving suppliers l Ensures suppliers can reliably supply materials that meet established specifications l Suppliers should be evaluated and approved before they are included in approved supplier's lists 8. 9 l Should take into account the supplier’s history and 8. 8, nature of materials to be supplied l Evaluation may also lead to an audit to assess compliance, e. g. with GMP Module 7 | January 2006 Slide 12 of 17 STOP
Self-Inspection Auditing the Self-Inspection Programme (1) l Check self-inspection programme at end of formal government GMP inspection, not at beginning l GMP inspectors should assess: ä the SOP ä programmes ä checklists or “aide-mémoires” Module 7 | January 2006 Slide 13 of 17 STOP
Self-Inspection Auditing the Self-Inspection Programme (2) l The SOP should describe teams, process, items covered, and the frequency of self-inspection l Company policy may not permit GMP inspector to see actual deficiency reports and corrective actions l GMP Inspectors should be looking for compliance with the selfinspection SOP - not necessarily at actual deficiencies recorded l Seek objective evidence of reports and action Module 7 | January 2006 Slide 14 of 17 STOP
Self-Inspection Auditing the Self-Inspection Programme (3) l Ensure company is not just doing housekeeping or safety audits l Check there are “Vertical” as well as normal “Horizontal” audits; both play valuable role in self-inspection Module 7 | January 2006 Slide 15 of 17 STOP
Self-Inspection Group Session l You are a GMP inspector in a large company with a diverse range of products l You are given the SOP, deficiency report form, and the selfinspection schedule l Prepare a report of your observations as to whether the company’s approach to self-inspection meets GMP guidelines Module 7 | January 2006 Slide 16 of 17 STOP
Self-Inspection Possible Issues l Size of the factory; phased inspection l Source of team leader l Source of team members l Reports and feedback Module 7 | January 2006 Slide 17 of 17 STOP
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