Good Practices for Quality Control Laboratories P art 4 : Inspecting the laboratory

1. Supplementary Training Modules on Good Manufacturing Practice Good Practices for Quality Control Laboratories Part 4: Inspecting the laboratory WHO Technical Report Series, No. 902, 2002. Annex 3

2. Quality Control Laboratories Objectives • To discuss ways in which a QC laboratory can be inspected

3. 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. Inspecting the QC Laboratory Inspection should cover (1): • Management and Infrastructure • Organization and management, quality system, documentation control and records • Data processing equipment • Personnel • Premises • Equipment and instruments

5. Inspecting the QC Laboratory Inspection should cover (2): • Materials, equipment and instruments • Specifications archive • Reagents • Reference standards • Calibration, validation and verification • Traceability

6. Inspecting the QC laboratory Inspection should cover (3): • Working procedures • Incoming samples • Analytical worksheet • Testing • Evaluation of results • Retained samples

7. Inspecting the QC laboratory 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

8. Inspecting the QC laboratory 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

9. Inspecting the QC laboratory 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

10. Inspecting the QC laboratory 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

11. Inspecting the QC laboratory 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

12. Inspecting the QC laboratory 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

13. Inspecting the QC laboratory 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

14. Inspecting the QC laboratory Analysis (5) Equipment: • Qualification protocols and reports • Calibration and verification • SOPs and records • Manuals • Training records

15. Inspecting the QC laboratory 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

16. Inspecting the QC laboratory Other checks • Water system • Compressed air • Steam • Environmental monitoring • Waste