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Book Summary
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
- ISBN-13
- 9781574443301
- Language
- English
- Binding
- Paper Back
- Publisher
- CBS Publishers & Distributors Pvt Ltd
- Publishing Date
- 2001-12-27
- Product Edition
- HRD
Pharmaceutical Master Validation Plan: The Ultimate Guide To Fda, Gmp And Glp Compliance With Cd
by Haider (Author),
CBS Publishers & Distributors Pvt Ltd (Publisher)
fictionfantasyyoung adultaward winning
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Product Specifications
Book Summary
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
Book Specifications
- ISBN-13
- 9781574443301
- Language
- English
- Binding
- Paper Back
- Publisher
- CBS Publishers & Distributors Pvt Ltd
- Publishing Date
- 2001-12-27
- Product Edition
- HRD