Supplementary Training Modules on Good Manufacturing Practice Inspecting the QC Laboratory This is module 4, Inspecting the QC Laboratory which is a supplement of the WHO Basic GMP Modules. This module is intended to take two to three hours with an option of 30 minutes for a Question and Answer session. There is no quiz or group session. However, the module has been designed to stimulate questions and discussions by the participants by including photographs wherever possible. The program is flexible and the times are approximate. As part of the preparation phase, the trainer will need to get an understanding of the audience and any special issues involved, such as language ability. The times allowed may then have to be altered accordingly. Allow for breaks of 20-30 minutes about every one-and-a-half hours. References used: Quality Assurance of Pharmaceuticals Volumes 1 and 2 ISBN 92 4 154504 6 ISBN 92 4 154526 7 WHO Technical Report Series, No. 902, 2002. Annex 3 Good practices for national pharmaceutical control laboratories.
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
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
Inspecting the QC laboratory Inspection should cover: Management and Infrastructure Materials, equipment and instruments Working procedures Safety
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
Inspecting the QC laboratory Inspection should cover (2): Materials, equipment and instruments Specifications archive Reagents Reference standards Calibration, validation and verification Traceability
Inspecting the QC laboratory Inspection should cover (3): Working procedures Incoming samples Analytical worksheet Testing Evaluation of results Retained samples
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
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
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
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
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
Inspecting the QC laboratory Analysis Equipment: Qualification protocols and reports Calibration and verification SOPs and records Manuals Training records
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
Inspecting the QC laboratory Other checks Water system Environmental monitoring Compressed air Steam Out of specifications Retained samples