Supplementary Training Modules on Good Manufacturing Practice

1. Inspecting the QC Laboratory Supplementary Training Modules on Good Manufacturing Practice

2. Inspecting the QC laboratory Performing the inspection Where to start: • Overview of the laboratory – walk through • Chemical, Instrumentation, Microbiology, Documentation, Storage areas • Organizational structure • Responsibilities and job descriptions • SOPs

3. Inspecting the QC laboratory Different types or ways of performing the inspection Achieve the same objective Routine type – similar to a GMP inspection: • Follow the flow of the material from the start to the end product – sample to result • Special inspection • Follow up inspection

4. Inspecting the QC laboratory Inspection should cover: • Management and Infrastructure • Materials, equipment and instruments • Working procedures • Safety

5. 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

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

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

8. Inspecting the QC laboratory Routine type inspection Follow the flow – verify implementation and compliance IN PRACTICE: • Incoming samples • Test request • Registration and labelling • Central register • Inspection and storage • Allocation of work

9. Inspecting the QC laboratory Analysis Specification (from archive) compared to the analytical reports • Tests and limits • Edition, version, pharmacopoeia • All tests performed, pharmacopoeia • Reagents used • Equipment and instruments used

10. Inspecting the QC laboratory Analysis 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

11. Inspecting the QC laboratory Analysis Analytical report and traceability • Reagents: SOPs and records • Equipment: Usage logs, entries, qualification (DQ, IQ, OQ, PQ), calibration and verification, maintenance, components (e.g. columns), SOPs and records, manuals

12. Inspecting the QC laboratory Analysis Reference materials: • Calibration and verification purposes • Analysis: Official reference materials, secondary and working standards - preparation and use • Registration and labelling • Central register • Information file • Inspection

13. Inspecting the QC laboratory Analysis Equipment: • Qualification protocols and reports • Calibration and verification • SOPs and records • Manuals • Training records

14. Inspecting the QC laboratory Computers, personnel and premises • Qualification • Qualification, experience, training • Premises • Space, mix-ups, different storage areas • Location • Utilities and waste • Environmental control and monitoring

15. Inspecting the QC laboratory Other checks • Water system • Environmental monitoring • Compressed air • Steam • Out of specifications • Retained samples