Validation Standard Operating Procedures

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A Step By Step Guide For Achieving Compliance In The Pharmaceutical, Medical

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A Step By Step Guide For Achieving Compliance In The Pharmaceutical, Medical

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

لغو

گزارش تخلف

مغایرت عنوان کتاب با توضیحات و تصویر جلد
عدم رعایت حقوق نشر طبق قوانین جمهوری اسلامی ایران
محتوای مستهجن
توهین به قومیتها و محتوای نژادپرستی
توهین به اقیلیتهای مذهبی
اهانت به مقامات سیاسی و مذهبی
اشاعه ی کودک آزاری
سایر موارد

بستن

فرمت کتاب

ebook

زبان

english

تاریخ انتشار

2001

نویسنده

Syed Imtiaz Haider

نویسنده

Syed Imtiaz Haider

ناشر

CRC Press

ناشر

CRC Press

شابک

9781574443318

20,000 تومان

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خرید کتاب Validation Standard Operating Procedures

Validation Standard Operating Procedures

گزارش تخلف

فرمت کتاب

ebook

زبان

english

تاریخ انتشار

2001

نویسنده

نویسنده

ناشر

ناشر

شابک

دیدگاه کاربران