Validation Standard Operating Procedures
Written on 10:12 AM by drabhishekn
A Step by Step Guide for Acheiving Compliance in the Pharmaceutical,
Medical Device, and Biotech Industries
About the Author:
Syed Imtiaz Haider earned his Ph.D. in chemistry
and is a quality assurance specialist with over ten years
experience in aseptic and nonaseptic pharmaceutical
processes, equipment validation, and in-process control
and auditing. Dr. Haider is the author and co-author of
more than 20 research publications in international refereed
journals dealing with products of pharmaceutical
interest, their isolation, and structure development. A
professional technical writer, Haider has authored more
than 500 standard operating procedures based on FDA
regulations, ISO 9001, and ISO 14001 standards.
About the book:
This book and CD-ROM take into account all major international regulations, such
as FDA, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA’s
concepts, Journal of PDA, GCP, and industry standard ISO 9000, to be in compliance
with documentation guidelines. No other book in print deals exclusively
with the key elements of validation procedure for pharmaceutical plants and provides
hands-on templates to be tailored to achieve FDA compliance.
Validation standard operating procedures are written to provide explicit
instruction on how to achieve the standards for those responsible for writing
and executing master validation plans for drug, drug-device combination, diagnostic,
pharmaceutical biotechnology, and bulk pharmaceutical chemicals products.
Included is the ready-to-use template so that one can immediately save time and
expense without missing any critical elements.
The book provides instant answers to validation engineers, validation specialists,
quality professionals, quality assurance auditors, and protocol writers about what
to include in validation standard operating procedures and how to enhance productivity.
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