QC | Slide 1 of 16 June 2006

Good Practices for Quality Control Laboratories

Part 4 :Inspecting the laboratory

Supplementary Training Modules on Good Manufacturing Practice

WHO Technical Report Series, No. 902, 2002. Annex 3

QC | Slide 2 of 16 June 2006

Quality Control LaboratoriesQuality Control Laboratories

Objectives

To discuss ways in which a QC laboratory can be inspected

QC | Slide 3 of 16 June 2006

Inspecting the QC LaboratoryInspecting 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

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

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

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

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

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

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

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

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

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

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

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

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

QC | Slide 16 of 16 June 2006

Other checks

Water system

Compressed air

Steam

Environmental monitoring

Waste

Inspecting the QC laboratory