1. Interview Task 1

2. GAMP
cGMP regulations imply that computerised systems, which have influence on the quality of an API should be validated.
Via - Good Automated Manufacturing Practices
Categories 1 – 5
Operating systems, network software
Standard Instruments, micro controllers
Standard software packages
Configurable software packages
Custom built or bespoke systems

3. e.g. Office applications, Configurable Software
GAMP Categories
GAMP 3
GAMP 4
Standard Software
Packages
e.g. Office applications,
spreadsheet,
date base systems
Configurable Software
Packages
E.g. LIMS, Enterprise
Resource Planning,
Chromatography data
systems

4. GAMP 3 or 4?
If it is based on e.g. Microsoft Access or Excel then it is GAMP 3 – the software itself does not need validation would need to concentrate on e.g.:
System requirements and functionality.
The high level language or macros used to build the application.
Critical algorithms and parameters.
Data integrity, accuracy and reliability.

5. Documentation What Documents (DHF)? IQ, OQ, PQ protocols & reports
Supplier review/audit report
Risk analysis report
System description (including hard/software diagrams)
Manuals and user guides
Training record
Functional specification
etc

6. Analysis Are Acceptance criteria met? Deviations justified?
Completeness of information collected
Problems encountered
Results
SOPs appropriate
Statistical analysis
System Change Control in place
etc

7. Presentation Requirements / Needs Validation Method
Documentation / Acceptance Criteria
Results
Meets required standard
ISO/CEI/2207
Verification complete and sign off
Hardware installation
IQ protocol
IQ protocol and report completed and signed off
Risk analysis
FMEA
Acceptance
criteria met
Signature
required
Missing
document
Review’s tasks
Contractor to
produce