Validation Standard Operating Procedures

1 ST. LUCIE PRESSA CRC Press CompanyBoca Raton London New York Washington, StandardOperating ProceduresA Step-by-Step Guide forAchieving compliance in thePharmaceutical, Medical Device,and Biotech IndustriesSyed Imtiaz Haider, 2002 by CRC Press LLCSome content within Val. , , , , , was excerpted or adaptedfrom USP-24 Chapter 1225 (pp. 2149-2152), Chapter 1227 (pp. 2152-2154), and Chapter 1116 ( ), as well as Water for Injection Specification (p. 1752) and Purified Water Specification ( ). United States Pharmacopoeial Convention, Inc., Rockville, MD. Copyright 1999 2000. Withpermission. Some content within Val. , to was excerpted or adapted from Carleton, F.

2 J. andAgalloco, J. P., Eds., Validation of Aseptic Pharmaceutical Process, Marcel Dekker, New York, book contains information obtained from authentic and highly regarded sources. Reprinted material isquoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable effortshave been made to publish reliable data and information, but the author and the publisher cannot assumeresponsibility for the validity of all materials or for the consequences of their this book nor any part may be reproduced or transmitted in any form or by any means, electronicor mechanical, including photocopying, microfilming, and recording, or by any information storage or retrievalsystem, without prior permission in writing from the consent of CRC Press LLC does not extend to copying for general distribution, for promotion, forcreating new works, or for resale.

3 Specific permission must be obtained in writing from CRC Press LLC forsuch all inquiries to CRC Press LLC, 2000 Corporate Blvd., Boca Raton, Florida Notice: Product or corporate names may be trademarks or registered trademarks, and are usedonly for identification and explanation, without intent to the CRC Press Web site at 2002 by CRC Press LLCSt. Lucie Press is an imprint of CRC Press LLCNo claim to original Government worksInternational 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 paperLibrary of Congress Cataloging-in-Publication DataHaider, Syed Standard Operating Procedures : a step-by-step guide for achievingcompliance in the pharmaceutical, medical device, and biotech industries/ by Syed Imtiaz 1-57444-331-31.

4 Pharmaceutical technology Quality control. 2. Pharmaceuticalindustry standards United States. 3. Biotechnology industries standards UnitedStates. 4. Medical instruments and apparatus industry standards United States. I..H353 2001681 .761 021873 dc212001048505 CIP 2002 by CRC Press LLCCONTENTSS ection VAL to ValidationSection VAL of Validation Master Plan and Guideline for DQ, IQ, OQ, and Qualification Guideline for Minimizing the Risk ofProduct Cross-Contamination by Air Handling Qualification Guideline for Minimizing the Risk ofCross-Contamination of Facility, Equipment, and Qualification Guideline for HVAC System ofa Pharmaceutical Qualification for the Prevention of Contamination ofNon-Sterile Pharmaceutical Qualification Guideline for Cross-Contaminationand Specifications for Process Specifications for Water for Injection Productionand Design Specifications for Purified Water (DIW)

5 Productionand Design Specifications for Pure Steam Productionand DistributionSection VAL for Change Control 2002 by CRC Press LLCS ection VAL of Review of the Calibration and Validation EquipmentSection VAL on the Manufacturing PracticesSection VAL for Area Classification and Air for Area Validation : Clean Area Validation Monitoring of Areas Used for Production ofSolids, Semi-Solids, and Testing for for of a Water Oil-Free Compressed Air Nitrogen Distribution Clean Vacuum Validation of an HVAC SystemSection VAL of a Steam Air Sterilization Tunnel Certification andValidation and Vial Washing , Sterilizing, and Drying Machine for and Vial Filling Fill Inspection Crack Detection Laminar Flow Sterile Filtration Cleaning Efficiency of Production Equipment for Parenterals 2002 by CRC Press LLCS ection VAL Bed Check Device for CoaterSection VAL Filling Wrapping and Bundling Filling and Closing Liquid Filling and Closing Tablet Filling and Closing MachineSection VAL Installation Qualification of Computerized Operational Qualification of Computerized Performance Qualification of Computerized EquipmentSection VAL Validation of Microbiological Validation of Analytical MethodsSection VAL Vendor

6 CertificationSection VAL Facility QualificationRecommended Reading 2002 by CRC Press LLCPREFACEAs the Validation master plan execution program proceeds and the facility is integratedinto regulatory guidelines of the FDA, current good manufacturing practice (cGMP),good laboratory practice (GLP), and the need for comprehensive and well-definedvalidation supporting Standard Operating Procedures are required. As the validationprogram progresses and the systems are integrated into routine operation, there arefewer deviations and the Standard Operating Procedures become more precise book and CD-ROM provide an administrative solution for execution of test functions defined in the Validation master plan proceduresis provided in the text and the electronic files.

7 The Validation Standard operatingprocedure can help your company comply with GMP, GLP, and Validation require-ments imposed by the formats and style provided are generic and can be further amended. Thecontents of the Standard Operating Procedures (SOPs) are intended to build qualityinto the regulatory requirements. However, having a set of Validation Standard oper-ating Procedures does not preclude adverse inspection findings, as contents that satisfyone inspector may not satisfy author strongly believes that the facility s technical management and staffshould 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.

8 It is, however, guaranteed to provide management with a tool todevelop a set of Validation SOPs in order to support the road map established forthe on-time successful start-up of the facility operation in compliance with the , medical, and biotech industries are regulated worldwide to bein compliance with cGMP and GLP principles. Each company is required to createvalidation SOPs to qualify its equipment, utilities, buildings, and personnel. Thetemplate Validation SOPs available enable end users to understand principles and 2002 by CRC Press LLCelements of good manufacturing practice and provide documentation languageranging from generic to specific, depending on the detail level of the to FDA regulations by the health care industry over the last decade hasbeen a major goal, including those companies intending to export their product to theUS market.

9 As a result, almost 300 companies are inspected around the world by theFDA every year for their GMP and GLP compliance . Only five to six companies areable to seek approval for exportation; one of the reasons behind this is the absence orinadequacy of Validation SOPs. Key benefits involve but are not limited to: 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 awarenessThe Validation Standard Operating Procedures on the CD-ROM are valuable toolsfor companies in the process of developing or revising VSOPs to achieve FDA,GMP, and GLP compliance .

10 The documentation package is especially relevant toquality assurance personnel, engineers, utilities engineers, computer engineers, val-idation designers, internal and external auditors, or to anyone interested in devel-oping a qualification documentation 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 Imtiaz Haider, 2001 2002 by CRC Press LLCDEDICATIONThis book is dedicated to my loving father Syed Mohsin Raza for his continuousmotivation.