Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Edition 2

Syed Imtiaz Haider

May 2006 · CRC Press

About this ebook

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Ratings and reviews

We have taking the referance of the dye ingress test method from your book and design the vacuum chamber, this method is like this: Actually we have designed the vaccum chamber, during the process filled with the dye solution. the product with positive samples put in the chamber. (Positive control samples - make 10micron hole with the laser drilled.) In case of the glass ampoules and vials the dye was as penetrated into positive control. But incase of the PVC bags the dye was not penetrated into the positive control.(Posive control samples spiked with the 26 gauge needle. ) Please clarify the problem

Probably has a lot of typos and incorrect information in it. I ready the section on lyophilization and found Fo (lethality) information in the shelf mapping section. Also a few typos in the few pages that I looked at. So probably not a thorough book. I would recommend "Validation of Pharmeutical Processes" by Agalloco and Carleton which I use daily for all kinds of validation knowledge.

this is a very nice book to understand about the documentation and steps which should be taken in the pharmaceutical products manufacturing, quality control, quality assurance, validation, media fill run, packaging etc.