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Pharmaceutical Validation Books
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
by Syed Imtiaz Haider

Hardcover: 208 pages
Publisher: CRC Press; Bk&CD-Rom edition (December 27, 2001)
Language: English
ISBN: 1574443305
Product Dimensions: 9.7 x 6.1 x 0.7 inches
Shipping Weight: 15.5 ounces
Book Description
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Book Info
(St. Lucie Press) Provides a generic format for a Master Validation Plan using a pharmaceutical manufacturing site with sterile and non-sterile operations as the case facility. Provides a road map for validation to establish FDA requirements/procedures, validation programs, protocols, and resource planning and scheduling. DNLM: Drug Industry--standards.
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical
by Syed Imtiaz Haider

Hardcover: 496 pages
Publisher: CRC Press; Bk&CD-Rom edition (December 27, 2001)
Language: English
ISBN: 1574443313
Product Dimensions: 9.5 x 6.3 x 1.3 inches
Shipping Weight: 2.0 pounds
Book Description
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.Features"Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines"Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols "Describes how to establish test functions and prevent defects in order to produce products that are fit for use"Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan
Pharmaceutical Process Validation: An International Edition
by Ira R. Berry (Editor), Alfred Wachter (Editor), Robert Nash (Editor), Robert A. Nash (Editor)

Hardcover: 912 pages
Publisher: Marcel Dekker; 3rd Rev edition (May, 2003)
Language: English
ISBN: 0824708385
Product Dimensions: 9.4 x 6.4 x 1.8 inches
Shipping Weight: 2.7 pounds
Pharmaceutical Validation Book Description
Banner Pharmacaps, Elizabeth, New Jersey. Drugs and the Pharmaceutical Sciences, Volume 57. New edition of a text for pharmaceutical researchers and manufacturers on good manufacturing practice and the applicability of process validation. 31 U.S. contributors. DNLM: Drug Evaluation standards - United States.

Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.
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