Self-Inspection and quality audits.ppt

World Health Organization Self-Inspection Objectives To identify the role of self-inspection in the quality management system To review the way in which a self-inspection programme should be carried out To discuss what to inspect and verify in a company’s self-inspection system Self-Inspection Principle (1) Purpose of self-inspection is to evaluate whether a company’s operations remain compliant with GMP Assists in ensuring quality improvement The programme should cover all aspects of production and quality control be designed to detect shortcomings in the implementation of GMP recommend corrective actions set a timetable for corrective action to be completed Self-Inspection Principle (2) Performed routinely Also on special occasions such as Recalls Repeated rejections When a GMP inspection is announced by the national drug regulatory authority Self-Inspection Principle (3) Self-inspection team should consist of personnel who: can evaluate the situation objectively have no conflict of interest, have no revenge in mind should have experience as observers of a self-inspection team before becoming a team member can be lead self-inspector with experience as team member Procedure should be documented Effective follow-up programme Self-Inspection 1. Self-inspection - informal (daily) Immediate correction 2. Self-inspection - formal (quarterly) Improve systems 3. QC - Internal Confirm compliance (half-yearly) Self-Inspection Items for Self-Inspection (1) Written instructions provide minimum and uniform standard Covering all aspects of GMP: personnel premises including personnel facilities maintenance of buildings and equipment storage of starting materials and finished products equipment production and in-process controls quality control Self-Inspection Items for Self-Inspection (2) documentation sanitation and hygiene validation and revalidation programmes calibration of instruments or measurement systems recall procedures complaints man