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Unformatted text preview: 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 PRES S 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 responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. Visit the CRC Press Web site at © 2002 by CRC Press LLC St. Lucie Press is an imprint of CRC Press LLC No claim to original U.S. Government works 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 200.00 200.10 200.20 200.30 Fundamentals of Validation SOPs Validation Master Plan and Guideline for DQ, IQ, OQ, and PQ 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 300.00 300.10 300.20 300.30 300.40 300.50 Validation Glossary Organization for Validation Revalidation Retrospective Validation Validation Change Control © 2002 by CRC Press LLC Section VAL 400.00 400.10 400.20 400.30 Calibration of Instruments Periodic Review of the Calibration Program Calibration and Validation Equipment Section VAL 500.00 500.10 500.20 Training on the Job Good Manufacturing Practices Section VAL 600.00 600.10 600.20 600.30 600.40 600.50 600.60 600.70 600.80 600.90 600.100 600.110 600.120 600.130 600.140 Guidelines for Area Classification and Air Handling Guideline for Area Validation: Clean Area Aseptic Area Validation Procedures Microbiological Monitoring of Areas Used for Production of Solids, Semi-Solids, and Liquids Efficiency Testing for Disinfectants Drinking Water Purified Water Water for Injection Validation of a Water System Oil-Free Compressed Air System Nitrogen Distribution System Clean Steam Vacuum System Validation of an HVAC System Section VAL 700.00 700.10 700.20 Validation of a Steam Sterilizer 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 800.00 800.10 800.20 800.30 800.40 800.50 800.60 800.70 800.80 Kneading Machine Oscillating Granulator Milling Machine Fluid Bed Drier Blender Tablet Press Metal Check Device for Tablets Tablet Coater Section VAL 900.00 900.10 900.20 900.30 900.40 900.50 900.60 900.70 900.80 900.90 900.100 900.110 Blistering Machine Blister Filling Machine Code Reader Sachetting Machine Cartoning Machine Labeling Machine Check Weigher Shrink Wrapping and Bundling Machine Tube Filling and Closing Machine Liquid Filling and Closing Machine 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 requirements 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 operating 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 reference to operational control within the organization and individual countries’ regulatory 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: 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 Successful facility operational start-up Minimized noncompliance Reduced reworks Reduced rejected lots Avoidance of recalled lots Help in new drug approval Satisfactory inspections Corporate image Financial gain Secure third-party contracts Corporate legal protection Utility cost reduction Minimized capital expenditures Fewer complaints Reduced testing 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, validation designers, internal and external auditors, or to anyone interested in developing 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 documentation to meet FDA and other regulatory requirements. Currently, no GMP document 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 ABOUT THE AUTHOR Syed Imtiaz Haider earned his Ph.D. in chemistry and is a quality assurance specialist with over ten years experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development. A professional technical writer, Haider has authored more than 500 standard operating procedures based on FDA regulations, ISO 9001, and ISO 14001 standards. He is a certified auditor of IRCA and a registered associate environmental auditor of EARA. He has written more than ten quality system manuals for multidisciplinary industries. Dr. Haider has also written ISO 9001:2000: Document Development Compliance Manual: A Complete Guide and CD-ROM, published by CRC Press and holds the copyright certificate of registration on an electronic documentation package on ISO 14001 from the Canadian intellectual property office. © 2002 by CRC Press LLC ABOUT THE BOOK This book and CD-ROM take into account all major international regulations, such as FDA, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA’s concepts, Journal of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other book in print deals exclusively with the key elements of validation procedure for pharmaceutical plants and provides hands-on templates to be tailored to achieve FDA compliance. Validation standard operating procedures are written to provide explicit instruction on how to achieve the standards for those responsible for writing and executing master validation plans for drug, drug-device combination, diagnostic, pharmaceutical biotechnology, and bulk pharmaceutical chemicals products. Included is the ready-to-use template so that one can immediately save time and expense without missing any critical elements. The book provides instant answers to validation engineers, validation specialists, quality professionals, quality assurance auditors, and protocol writers about what to include in validation standard operating procedures and how to enhance productivity. Introduction 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 SOP Format SOP Number SOP Title Date Author Checked by Approved by Revision Subject Responsibility © 2002 by CRC Press LLC 䡲 Purpose 䡲 Procedure 䡲 Reasons For Revision The book and CD-ROM are designed for individuals specifically involved in writing and execution of master validation plans, development of protocols, and applicable procedures. This book provides a complete, single-source reference detailing conceptual design elements and more than 70 explicit procedures for validation. © 2002 by CRC Press LLC INTRODUCTION 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. SOP Format All SOPs have been uniformally designed and formatted. Information common to all SOPs is described below. First Page Company Name — At the top of each SOP, a box is provided to enter your company name. SOP Number — Each SOP is assigned a unique number that appears at the upper-left corner of each page. Title — The title of each SOP appears at the top of the first two pages below the SOP number. The title describes the subject of the SOP. Date — Each SOP is assigned an effective date at the top of the page, to the right of the SOP number. The date describes the month, day, and year of implementation. © 2002 by CRC Press LLC Author — Each SOP is assigned a space to provide the author name, title, and the department, along with signatures and dates. Checked by — Each SOP is assigned a space to provide the name, title, and the department of the person responsible for checking the contents of the SOP requiring the signature and date. Approved By — Each page of the SOP provides a space for the signature of the quality assurance or manager approving the SOP to prevent unauthorized changes. Revisions — At the end of each page is the revisions box. This box documents the revision number, section, pages, initials, and date. Other Pages Subject — Each SOP begins with the subject to provide key description of the SOP. Purpose — Each SOP is supported with reasons, describing the purpose. Responsibility — The space for responsibility clearly identifies who has to follow the procedures and who is responsible for the overall compliance with the SOP. Procedure — Following the purpose statement are the individual steps of the SOP, arranged in logical order to make the SOP easy to perform. Reason for Revision — At the end of each SOP, a space is provided to list the reasons why the SOP is changed, along with the date. CD-ROM — An electronic copy of the generic validation standard operating procedures is provided. DISCLAIMER Every effort has been made to ensure that the contents of the generic validation standard operating procedures are accurate and that recommendations are appropriate and made in good faith. The author accepts no responsibility for inaccuracies or actions taken by companies subsequent to these recommendations. The similarity in the contents of the procedure with a particular reference to the test functions, acceptance criteria, qualification protocols, and checks may be incidental because of the similarity in principle and operations of pharmaceutical equipment. © 2002 by CRC Press LLC SECTION VAL 100.00 © 2002 by CRC Press LLC YOUR COMPANY VALIDATION STANDARD OPERATING PROCEDURE SOP No. Val. 100.10 Effective date: mm/dd/yyyy Approved by: TITLE: Introduction to Validation AUTHOR: ________________________________________ Name/Title/Department ________________________________________ Signature/Date CHECKED BY: ________________________________________ Name/Title/Department ________________________________________ Signature/Date APPROVED BY: ________________________________________ Name/Title/Department ________________________________________ Signature/Date REVISIONS: No. © 2002 by CRC Press LLC Section Pages Initials/Date SOP No. Val. 100.10 Effective date: mm/dd/yyyy Approved by: SUBJECT: Introduction to Validation PURPOSE To describe the definition, types, and benefits of validation RESPONSIBILITY It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. PROCEDURE 1. Definition of Validation Validation is a systematic approach to gathering and analyzing sufficient data which will give reasonable assurance (documented evidence), based upon scientific judgment, that a process, when operating within specified parameters, will consistently produce results within predetermined specifications. 2. Type of Validation 䡲 䡲 䡲 䡲 Retrospective Validation Prospective Validation Concurrent Validation Revalidation 2.1 Retrospective Validation Validation of a process for a product already in distribution, based on accumulated production, testing, and control dates. Summary of existing historical data. 2.2 Prospective Validation Validation conducted prior to distribution either of a new product, or a product made under a revised manufacturing process. Validation is completed and the results are approved prior to any product release. © 2002 by CRC Press LLC SOP No. Val. 100.10 Effective date: mm/dd/yyyy Approved by: 2.3 Concurrent Validation A combination of retrospective and prospective validation. Performed against an approved protocol but product is released on a lot-by-lot basis. Usually used on an existing product not previously validated or insufficiently validated. 2.4 Revalidation To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity. 3. Importance of Validation 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 䡲 Increased throughput Reduction in rejections and reworking Reduction in utility costs Avoidance of capital expenditures Fewer complaints about process-related failures Reduced testing in-process and in finished goods More rapid and reliable start-up of new equip...
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  • Summer '17
  • kim kwang
  • Verification and validation, CRC Press, CRC Press LLC

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