1. © WHO – PSM Quality Control Laboratory Pharmaceutical Quality, Good manufacturing Practice & Bioequivalence Kiev, Ukraine 3 - 7 October 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: hietavam@who.int Basic Principles of GMP Part One, 17

2. © WHO – PSM Inspection should cover: l Management and Infrastructure l Materials, equipment and instruments l Working procedures l Safety Inspecting the QC laboratory

3. © WHO – PSM Inspection should cover (1): l Management and Infrastructure ä Organization and management, quality system, documentation control and records ä Data processing equipment ä Personnel ä Premises ä Equipment and instruments Inspecting the QC laboratory

4. © WHO – PSM Inspection should cover (2): l Materials, equipment and instruments ä Specifications archive ä Reagents ä Reference standards ä Calibration, validation and verification ä Trace-ability Inspecting the QC laboratory

5. © WHO – PSM Inspecting the QC laboratory Inspection should cover (3): Working procedures ä Incoming samples ä Analytical worksheet ä Testing ä Evaluation of results ä Retained samples ä OOS situation handling (SOP) ä Sampling ä In-process controls ä Cleaning of the equipment, vessels and containers ä Change control

6. © WHO – PSM Different types or ways of performing the inspection l Routine type – similar to a GMP inspection ä Inspection Along the Material Flow – Sample to Result ä Product Specific Approach l Special inspection l Follow up inspection Inspecting the QC laboratory

7. © WHO – PSM Performing the inspection (1) Where to start: l Overview of the laboratory – walk through l Chemical, Instrumentation, Microbiology, Documentation, Storage areas l Organizational structure l Responsibilities and job descriptions l SOPs Inspecting the QC laboratory

8. © WHO – PSM Performing the Inspection (2) Follow the flow – verify implementation and compliance IN PRACTICE: l Incoming samples ä Test request ä Registration in a central register and labelling ä Allocation of work l Incoming reagents, chemicals and reference materials ä Inspection and storage ä Central register Inspecting the QC laboratory

9. © WHO – PSM Analysis (1) Specifications (from archive) compared to the analytical reports l Tests and limits l Edition, version, pharmacopoeia l All tests performed, pharmacopoeia l Reagents used l Equipment and instruments used Inspecting the QC laboratory

10. © WHO – PSM Analysis (2) Specification (from archive) compared to the analytical reports l Log books – including calculations l Print outs and sheets l Raw data, chromatograms, spectra l Signatures and dates, evaluation of results l Trace-ability Inspecting the QC laboratory

11. © WHO – PSM Analysis (3) Analytical report and trace-ability l Reference materials, reagents and chemicals: SOPs and records l Equipment: Usage logs, entries, qualification (DQ, IQ, OQ, PQ), calibration and verification, maintenance, components (e.g. columns), SOPs and records, manuals Inspecting the QC laboratory

12. © WHO – PSM Analysis (4) Reference materials: l Calibration and verification purposes l Analysis: Official reference materials, secondary and working standards - preparation and use ä Registration, inspection and labelling ä Central register ä Information file ä Inspection at regular intervals Inspecting the QC laboratory

13. © WHO – PSM Analysis (5) Equipment: l Qualification protocols and reports l Calibration and verification l SOPs and records l Manuals l Training records l Deep freezers and refrigerators l Decubators/temperature mapping Inspecting the QC laboratory

14. © WHO – PSM Additional points to consider l Qualification and validation of computers l Qualification, experience, training of personnel ä See if lab technicians use the current SOP for analysis l Premises, location, space, mix-ups, different storage areas l Out of specifications l Retained samples l Utilities and waste l Environmental control and monitoring Inspecting the QC laboratory

15. © WHO – PSM Other checks l Water system l Compressed air l Steam l Environmental monitoring l Waste Inspecting the QC laboratory

16. © WHO – PSM Inspecting the QC Laboratory Supplementary Training Modules on Good Manufacturing Practice