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GMP Volumes

out of stock - Validation Procedures - GMP MANUAL Volume 2 - out of stock!
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Edition: 1st edition 2010
ca. 500 Pages
Format: DIN A4

ISBN: 978-3-934971-78-3
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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
Recommendations
Computer Infrastructure Qualification For FDA Regulated Industries
Validation of Analytical Methods for Biopharmaceuticals