Asif, Erfan Syed Pharmaceutical vendors approval manual 9781032030883

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Автор: Asif, Erfan Syed
Название: Pharmaceutical vendors approval manual
ISBN: 9781032030883
Издательство: Taylor&Francis
Классификация:

Отрасли обрабатывающей промышленности

Полиграфическая, упаковочная и репрографическая промышленность

Медицина: общие вопросы

Технологии производства фармацевтических препаратов

ISBN-10: 1032030887
Обложка/Формат: Hardcover
Страницы: 152
Вес: 0.40 кг.
Дата издания: 13.12.2021
Язык: English
Иллюстрации: 1 line drawings, black and white; 1 halftones, black and white; 2 illustrations, black and white
Размер: 23.39 x 15.60 x 1.12 cm
Подзаголовок: A comprehensive quality manual for api and packaging material approval
Рейтинг:
Поставляется из: Европейский союз
Описание: This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.This bookprovides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry
Дополнительное описание: 1. Finding and Partnering Active Pharmaceutical Ingredients Vendor. 2. Selection of API Vendors and the impacts on Drug products. 3. Approach, Team formation and Planning. 4. Site Standard Operating Procedure for vendors approv

Pharmaceutical vendors approval manual, Asif, Erfan Syed