The first edition of this book was well received by the pharmaceutical industry and pharmacy education institutions. Over the years, since this book was published, there have been some changes e.g. acceptance limits in media fill trials, acceptance limits in cleaning validation. Thus, there was a need for review of this book.
In the first edition, process validation, in general, was discussed and then some special processes were discussed. But validation of packaging process was not discussed. In this edition, a chapter has been added on packaging process validation.
Medical devices is an emerging field in India. Several medical devices have been notified as drugs by Government of India. However, processes used in medical devices are much varied than the processes used in the pharmaceutical industry. Therefore, a chapter has been included in this edition, on validation of medical devices.
Before process validation can be undertaken effectively, two important activities are calibration of measuring devices and qualification of equipment/instruments. Unless these two activities have been done correctly, validation will not be reliable. Therefore, a chapter has been included on calibration and qualification of equipment/instruments in this edition.
All the chapters of the first edition of this book have been reviewed and updated.