Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
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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________________________________________ APPROVED ________________________________________ CHECKED ________________________________________ Name/Title/Department ________________________________________ ________________________________________ REVISIONS ________________________________________ Signature/Date APPROVED ________________________________________ Signature/Date CHECKED ________________________________________ Signature/Date Name/Title/Department ________________________________________ Signature/Date REVISIONS Acceptance criteria afﬁliates air ﬂow ampules anemometer areas certiﬁcation clean COMPANY VALIDATION STANDARD containers contract manu cross-contamination deﬁned document ducts ensure facturers YOUR COMPANY ﬁll ﬁlling ﬁnal follow the procedure Frequency Initial validation Guideline heat HEPA ﬁlters HVAC identiﬁed machine manager is responsible manager to follow manufacturer materials measuring medium method microbial microorganisms mm/dd/yyyy Approved monitoring Name/Title/Department ________________________________________ Signature/Date OPERATING PROCEDURE SOP operations manual Pages Initials/Date SOP particle performance qualiﬁcation pressure PURPOSE To describe quality assurance manager REASONS FOR REVISION responsible for SOP REVISION Effective date sample Section Pages Initials/Date serial number Signature/Date Name/Title/Department ________________________________________ SOP compliance speciﬁcations stainless steel STANDARD OPERATING PROCEDURE steam sterilizer tablet technical services manager temperature thermocouples tubing VALIDATION STANDARD OPERATING validation team valves velocity Water for Injection welding