1. QC | Slide 1 of 16 June 2006 Good Practices for Quality Control Laboratories P art 4: Inspecting the laboratory Supplementary Training Modules on Good Manufacturing Practice WHO Technical Report Series, No. 902, 2002. Annex 3

2. QC | Slide 2 of 16 June 2006 Quality Control Laboratories Objectives To discuss ways in which a QC laboratory can be inspected

3. QC | Slide 3 of 16 June 2006 Inspecting the QC Laboratory Elements of the module Introduction Part 1: Management & infrastructure Part 2: Materials, equipment, instruments, and other devices Part 3: Working procedures Part 4: Safety

4. QC | Slide 4 of 16 June 2006 Inspection should cover (1): Management and Infrastructure –Organization and management, quality system, documentation control and records –Data processing equipment –Personnel –Premises –Equipment and instruments Inspecting the QC Laboratory

5. QC | Slide 5 of 16 June 2006 Inspection should cover (2): Materials, equipment and instruments –Specifications archive –Reagents –Reference standards –Calibration, validation and verification –Traceability Inspecting the QC Laboratory

6. QC | Slide 6 of 16 June 2006 Inspection should cover (3): Working procedures –Incoming samples –Analytical worksheet –Testing –Evaluation of results –Retained samples Inspecting the QC laboratory

7. QC | Slide 7 of 16 June 2006 Different types or ways of performing the inspection Routine type – similar to a GMP inspection –Inspection Along the Material Flow – Sample to Result –Product Specific Approach Special inspection Follow-up inspection Inspecting the QC laboratory

8. QC | Slide 8 of 16 June 2006 Performing the inspection (1) Where to start: Overview of the laboratory – walk through Chemical, Instrumentation, Microbiology, Documentation, Storage areas Organizational structure, responsibilities and job descriptions SOPs and other documents Inspecting the QC laboratory

9. QC | Slide 9 of 16 June 2006 Performing the Inspection (2) Follow the flow – verify implementation and compliance –Incoming samples –Test request –Registration in a central register and labelling –Allocation of work Incoming reagents, chemicals and reference materials –Inspection and storage –Central register Inspecting the QC laboratory

10. QC | Slide 10 of 16 June 2006 Analysis (1) Specifications (from archive) compared to the analytical reports Tests and limits Edition, version, pharmacopoeia All tests performed, pharmacopoeia Reagents used Equipment and instruments used Inspecting the QC laboratory

11. QC | Slide 11 of 16 June 2006 Analysis (2) Specification (from archive) compared to the analytical reports Log books – including calculations Print-outs and sheets Raw data, chromatograms, spectra Signatures and dates, evaluation of results Traceability Inspecting the QC laboratory

12. QC | Slide 12 of 16 June 2006 Analysis (3) Analytical report and traceability Reference materials, reagents and chemicals: SOPs and records 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

13. QC | Slide 13 of 16 June 2006 Analysis (4) Reference materials: Calibration and verification purposes Analysis: official reference materials, secondary and working standards – preparation and use –Registration, inspection and labelling –Central register –Information file –Inspection at regular intervals Inspecting the QC laboratory

14. QC | Slide 14 of 16 June 2006 Analysis (5) Equipment: Qualification protocols and reports Calibration and verification SOPs and records Manuals Training records Inspecting the QC laboratory

15. QC | Slide 15 of 16 June 2006 Additional points to consider Qualification and validation of computers Qualification, experience, training of personnel Premises, location, space, mix-ups, different storage areas Out-of-specification result investigation Retained samples Utilities and waste, environmental control and monitoring Inspecting the QC laboratory

16. QC | Slide 16 of 16 June 2006 Other checks Water system Compressed air Steam Environmental monitoring Waste Inspecting the QC laboratory