1. 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 minutes about every one-and-a-half hours.
References used:
Quality Assurance of Pharmaceuticals Volumes 1 and 2
ISBN
ISBN
WHO Technical Report Series, No. 902, Annex 3 Good practices for national pharmaceutical control laboratories.

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