PIC/S PI 006-4: What Does it Mean in Practice?
Updated Recommendations on Qualification and Validation
Learn about the key additions and changes compared with PI 006-3 in areas such as risk management, qualification, FAT/SAT, utilities, and more.
A PDF free of charge.
What has changed since the previous version and what does PI 006-4 add to Annex 15?
An overview at a glance.
Internationally, PIC/S PI 006 is the core (non-binding) validation guideline for inspectors and manufacturers. It covers qualification of equipment, utilities, and systems, as well as process and cleaning validation across all pharma manufacturing.
GMP expert Dr Sabine Paris has analysed the key changes for you. PIC/S PI 006-4 aligns with Annex 15, while providing more detailed guidance on how the lifecycle and risk-based principles should be implemented in practice.
Request your PDF here, free of charge. Just enter your email adress on the left.
Detailed information on the practical implementation of Annex 15, “Qualification and Validation”,
... can be found in the GMP Compliance Adviser, the most comprehensive GMP online knowledge portal worldwide, combining theory and practice.
- Easy access to 60+ comprehensive, field-tested sample documents
- Up-to-date, practical, and inspection-tested
The demo access is non-binding, free of charge, and ends automatically.
