Electronic Resource

Validation Standard Operating Procedures : A Step-by-Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device,and Biotech Industries

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This book was designed and written for validation professionals responsible for writing and maintaining quality management systems for the successful operation of their companies. It provides a set of standard operating procedures (SOPs) that can be used to manage and document critical validation and revalidation tasks in a pharmaceutical manufacturing facility. The numbering of the sections and related SOPs begins with 200 and goes through 1300. In addition the reader may add SOPs that are unique to his facility. The term responsible person is used extensively throughout the SOPs. The term refers to the person who has been delegated authority by management and deemed responsible for performing duties associated with validation tasks within the facility.

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Ketersediaan

EBK-00240

681.761/Sye-v

Perpus Pusat

Tersedia

Informasi Detail

Judul Seri

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No. Panggil

681.761/Sye-v

Penerbit

New York : CRC Press Company., 2002

Deskripsi Fisik

429 hlm

Bahasa

Indonesia

ISBN/ISSN

1-57444-331-3

Klasifikasi

681.761

Tipe Isi

text

Tipe Media

e-book

Tipe Pembawa

-

Edisi

-

Subjek

Pharmaceutical technology
Quality control
Pharmaceutical
Biotechnology industries
. Medical instruments and apparatus industry

Info Detail Spesifik

Electronic Version

Pernyataan Tanggungjawab

-

Versi lain/terkait

Lampiran Berkas

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