Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
CRC Press, Dec 27, 2001 - Business & Economics - 496 pages
One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.
This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.
The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit.
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Validation Standard Operating Procedures: A Step by Step Guide for Achieving ...
Syed Imtiaz Haider
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________________________________________ Name/Title/Department ________________________________________ ________________________________________ Signature/Date Name/Title/Department Acceptance afﬁliates air handling appropriate areas AUTHOR calibration Check clean COMPANY VALIDATION STANDARD components containers contract manu correct count criteria critical describe determine distribution document drawings ducts Effective date ensure equipment Establish facility ﬁlter Frequency function Guideline heat issued limits List load machine maintenance manager is responsible manual manufacturer materials measuring medium meet method mm/dd/yyyy Approved monitoring Name/Title/Department ________________________________________ Signature/Date once OPERATING PROCEDURE SOP Pages Initials/Date SOP particle performed plate pressure Qualiﬁcation quality assurance manager REASONS FOR REVISION records relevant requirements responsible responsible for SOP Revalidation REVISION Effective date sample Section Pages Initials/Date Signature/Date Name/Title/Department ________________________________________ SOP compliance speciﬁcations STANDARD OPERATING PROCEDURE steam sterilizer SUBJECT supply surface temperature TITLE tubing unit utilities VALIDATION STANDARD OPERATING Verify volume