sold out

Qualification
- Official requirements
- Preparation of the qualification
- Qualification documentation
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification(OQ)
- Performance qualification (PQ)
- Special cases of qualification

Process Validation (This chapter is also available as PDF file for download)
- Official requirements
- Validation – a key element of quality assurance
- Process validation approaches
- Revalidation
- Planning of process validation projects
- Validation master plan
- Risk analysis
- Validation protocol and report
- Quality by Design
- Process Analytical Technology (PAT)

Cleaning Validation
- Official requirements
- How to validate cleaning procedures
- Cleaning validation master plan
- Establishing the scope of validation
- Acceptance criteria and limit calculation
- Sampling procedures
- Analytical procedures
- Documentation
- Maintenance of the validated status
- Cleaning validation documentation (example)
- References

Computer Validation (This chapter is also available as PDF file for download)
- Introduction and basic terminology
- Regulatory aspects
- Life cycle of software and systems
- Risk analysis and system classification
- Validation of computerised systems
- Operation of computerised systems
- External service providers
- References

Dr. Doris Borchert
Dr. Peter Bosshard
Dr. Ralph Gomez
Dr. Michael Hiob
Max Lazar
Dr. Christine Oechslein
Ulrike Reuter
Michael Schulte
Uwe Schwarzat

Excerpt from the GMP MANUAL