Validation in Pharmaceutical Industry authored by senior regulatory officer of Delhi Govt. was published in 2007. Validation is a part of Good Manufacturing Practices (GMPs). This element of GMPs is most enquired aspect during the regulatory inspections. All GMP texts, national, regional and international have this element. Validation element, under the GMP, include qualification on facilities, equipment and utilities and process validation.
In this title, the author has dwelled upon concepts, options and validation of different processes. Documentation is an essential requirement of GMP. Validation documentation assumes importance because of its necessity for repeated intended performance of the process. Documentation like Validation Master Plan (VMP), qualification documentation (DQ,IQ,OQ, PQ), validation protocol, ETOP, change control documents have been explained.
Since statistical formulae are used in handling data generated during validation experiments, a chapter has been included in the book on statistical principles and tools used in validation and quality control of drugs.
There are chapters on qualification of facilities including HVAC, utilities like water, steam, validation of special processes like aseptic process, lyophilization. Now a day, computers are used to regulate processes, therefore, a chapter has been included on computer system validation.
The book has been reviewed and updated and three new chapters have been added in the second edition of this book which has been published in 2013. Highlights of the second edition are:
Three new chapters added, the following
- Calibration and Qualification
- Validation of Packaging Operations
- Process Validation and Medical Devices
Texts of all chapters of first edition reviewed and updated
Guidance formats included for
- Qualification and Validation Protocols
- Change Control
- Qualification Matrix
- Control Charts