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

431 Pages·2001·2.04 MB·English

by  Syed Imtiaz Haider

Validation Standard
Operating Procedures
A Step-by-Step Guide for
Achieving Compliance in the
Pharmaceutical, Medical Device,
and Biotech Industries
Syed Imtiaz Haider, Ph.D.
ST. LUCIE PRESS
A CRC Press Company
Boca Raton London New York Washington, D.C.
© 2002 by CRC Press LLC
Some content within Val. 600.90, 200.10, 600.70, 600.30, 1100.10, 1100.20 was excerpted or adapted
from USP-24 – Chapter 1225 (pp. 2149-2152), Chapter 1227 (pp. 2152-2154), and Chapter 1116 (pp.
2099-2104), as well as Water for Injection Specification (p. 1752) and Purified Water Specification (p.
1753). United States Pharmacopoeial Convention, Inc., Rockville, MD. Copyright 1999–2000. With
permission.
Some content within Val. 600.30, 600.60 to 600.130 was excerpted or adapted from Carleton, F. J. and
Agalloco, J. P., Eds.,Validation of Aseptic Pharmaceutical Process, Marcel Dekker, New York, 1998.
With permission.
Library of Congress Cataloging-in-Publication Data
Haider, Syed Imtiaz.
Validation standard operating procedures: a step-by-step guide for achieving
compliance in the pharmaceutical, medical device, and biotech industries
/ by Syed Imtiaz Haider.
p. cm.
ISBN 1-57444-331-3
1. Pharmaceutical technology—Quality control. 2. Pharmaceutical
industry—Standards—United States. 3. Biotechnology industries—Standards United
States. 4. Medical instruments and apparatus industry—Standards—United States. I. Title.
RS192 .H353 2001
681′.761′021873—dc21 2001048505
CIP
This book contains information obtained from authentic and highly regarded sources. Reprinted material is
quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts
have been made to publish reliable data and information, but the author and the publisher cannot assume
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© 2002 by CRC Press LLC
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International Standard Book Number 1-57444-331-3
Library of Congress Card Number 2001048505
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
Printed on acid-free paper
© 2002 by CRC Press LLC
CONTENTS
Section VAL 100.00
100.10 Introduction to Validation
Section VAL 200.00
200.10 Fundamentals of Validation SOPs
200.20 Validation Master Plan and Guideline for DQ, IQ, OQ, and PQ
200.30 Design Qualification Guideline for Minimizing the Risk of
Product Cross-Contamination by Air Handling System
200.40 Design Qualification Guideline for Minimizing the Risk of
Cross-Contamination of Facility, Equipment, and Process
200.50 Design Qualification Guideline for HVAC System of
a Pharmaceutical Plant
200.60 Design Qualification for the Prevention of Contamination of
Non-Sterile Pharmaceutical Products
200.70 Design Qualification Guideline for Cross-Contamination
and Decontamination
200.80 Design Specifications for Process Water
200.90 Design Specifications for Water for Injection Production
and Distribution
200.100 Design Specifications for Purified Water (DIW) Production
and Distribution
200.110 Design Specifications for Pure Steam Production
and Distribution
Section VAL 300.00
300.10 Validation Glossary
300.20 Organization for Validation
300.30 Revalidation
300.40 Retrospective Validation
300.50 Validation Change Control
© 2002 by CRC Press LLC
Section VAL 400.00
400.10 Calibration of Instruments
400.20 Periodic Review of the Calibration Program
400.30 Calibration and Validation Equipment
Section VAL 500.00
500.10 Training on the Job
500.20 Good Manufacturing Practices
Section VAL 600.00
600.10 Guidelines for Area Classification and Air Handling
600.20 Guideline for Area Validation: Clean Area
600.30 Aseptic Area Validation Procedures
600.40 Microbiological Monitoring of Areas Used for Production of
Solids, Semi-Solids, and Liquids
600.50 Efficiency Testing for Disinfectants
600.60 Drinking Water
600.70 Purified Water
600.80 Water for Injection
600.90 Validation of a Water System
600.100 Oil-Free Compressed Air System
600.110 Nitrogen Distribution System
600.120 Clean Steam
600.130 Vacuum System
600.140 Validation of an HVAC System
Section VAL 700.00
700.10 Validation of a Steam Sterilizer
700.20 Hot Air Sterilization Tunnel Certification and
Validation Guideline
700.30 Freeze Drier
700.40 Ampule and Vial Washing Machine
700.50 Washing, Sterilizing, and Drying Machine for Stoppers
700.60 Ampule and Vial Filling Machine
700.70 Media Fill Run
700.80 Half-Automatic Inspection Machine
700.90 Ampule Crack Detection Machine
700.100 Laminar Flow Installations
700.110 Sterile Filtration Validation
700.120 Cleaning Efficiency of Production Equipment for Parenterals
© 2002 by CRC Press LLC
Section VAL 800.00
800.10 Kneading Machine
800.20 Oscillating Granulator
800.30 Milling Machine
800.40 Fluid Bed Drier
800.50 Blender
800.60 Tablet Press
800.70 Metal Check Device for Tablets
800.80 Tablet Coater
Section VAL 900.00
900.10 Blistering Machine
900.20 Blister Filling Machine
900.30 Code Reader
900.40 Sachetting Machine
900.50 Cartoning Machine
900.60 Labeling Machine
900.70 Check Weigher
900.80 Shrink Wrapping and Bundling Machine
900.90 Tube Filling and Closing Machine
900.100 Liquid Filling and Closing Machine
900.110 Tablet Filling and Closing Machine
Section VAL 1000.00
1000.10 Installation Qualification of Computerized Equipment
1000.20 Operational Qualification of Computerized Equipment
1000.30 Performance Qualification of Computerized Equipment
Section VAL 1100.00
1100.10 Validation of Microbiological Methods
1100.20 Validation of Analytical Methods
Section VAL 1200.00
1200.10 Vendor Certification
Section VAL 1300.00
1300.10 Facility Qualification
Recommended Reading
© 2002 by CRC Press LLC
PREFACE
As the validation master plan execution program proceeds and the facility is integrated
into regulatory guidelines of the FDA, current good manufacturing practice (cGMP),
good laboratory practice (GLP), and the need for comprehensive and well-defined
validation supporting standard operating procedures are required. As the validation
program progresses and the systems are integrated into routine operation, there are
fewer deviations and the standard operating procedures become more precise and
complete.
This book and CD-ROM provide an administrative solution for management.
The execution of test functions defined in the validation master plan procedures
is provided in the text and the electronic files. The validation standard operating
procedure can help your company comply with GMP, GLP, and validation require-
ments imposed by the FDA.
The formats and style provided are generic and can be further amended. The
contents of the standard operating procedures (SOPs) are intended to build quality
into the regulatory requirements. However, having a set of validation standard oper-
ating procedures does not preclude adverse inspection findings, as contents that satisfy
one inspector may not satisfy another.
The author strongly believes that the facility’s technical management and staff
should read the procedures to ensure that particular needs are addressed with refer-
ence to operational control within the organization and individual countries’ regula-
tory requirements. It is, however, guaranteed to provide management with a tool to
develop a set of validation SOPs in order to support the road map established for
the on-time successful start-up of the facility operation in compliance with the GMP
requirement.
Pharmaceutical, medical, and biotech industries are regulated worldwide to be
in compliance with cGMP and GLP principles. Each company is required to create
validation SOPs to qualify its equipment, utilities, buildings, and personnel. The
template validation SOPs available enable end users to understand principles and
© 2002 by CRC Press LLC
elements of good manufacturing practice and provide documentation language
ranging from generic to specific, depending on the detail level of the requirements.
Compliance to FDA regulations by the health care industry over the last decade has
been a major goal, including those companies intending to export their product to the
US market. As a result, almost 300 companies are inspected around the world by the
FDA every year for their GMP and GLP compliance. Only five to six companies are
able to seek approval for exportation; one of the reasons behind this is the absence or
inadequacy of validation SOPs. Key benefits involve but are not limited to:
(cid:1) Successful facility operational start-up
(cid:1) Minimized noncompliance
(cid:1) Reduced reworks
(cid:1) Reduced rejected lots
(cid:1) Avoidance of recalled lots
(cid:1) Help in new drug approval
(cid:1) Satisfactory inspections
(cid:1) Corporate image
(cid:1) Financial gain
(cid:1) Secure third-party contracts
(cid:1) Corporate legal protection
(cid:1) Utility cost reduction
(cid:1) Minimized capital expenditures
(cid:1) Fewer complaints
(cid:1) Reduced testing
(cid:1) Improved employee awareness
The validation standard operating procedures on the CD-ROM are valuable tools
for companies in the process of developing or revising VSOPs to achieve FDA,
GMP, and GLP compliance. The documentation package is especially relevant to
quality assurance personnel, engineers, utilities engineers, computer engineers, val-
idation designers, internal and external auditors, or to anyone interested in devel-
oping a qualification documentation matrix.
The author believes that by following the broadly based example of these VSOPs,
both new and experienced companies can benefit by enhancing their existing docu-
mentation to meet FDA and other regulatory requirements. Currently, no GMP doc-
ument specifically describes the format of these validation standard operating
procedures.
Syed Imtiaz Haider, Ph.D.
July 2001
© 2002 by CRC Press LLC
DEDICATION
This book is dedicated to my loving father Syed Mohsin Raza for his continuous
motivation. I am also indebted to my wife Shazia for her patience while I compiled
this book.
© 2002 by CRC Press LLC
ACKNOWLEDGMENT
The author would like to thank his friends and colleagues, especially Mr.Javed
Zamir and Mr. Zahid Haleem for their help and encouragement and for creating
a professional environment. Special thanks to the staff of CRC Press, particularly
Drew Gierman and Judith Simon Kamin for their patience and diligence in the
production of this book.
© 2002 by CRC Press LLC