O RAL C. apsules HANDBOOK OF PHARMACEUTICAL GENERIC DEVELOPMENT. VOLUME II - PART ONE Drug Development - Solid Oral Dosage Forms.
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1 HANDBOOK OF PHARMACEUTICAL GENERIC DEVELOPMENT O RAL C Immediate Release apsules VOLUME II - PART ONE Drug Development - Solid Oral Dosage Forms Handbook of Pharmaceutical Generic Development Series
2 ORAL CAPSULE DOSAGE FORM Drug Development HPGD 24 Volume SERIES - ORAL CAPSULES - Part I First & Second Int. Edition - 01 & 02 (First & second print run) Published 1995/6/7/8. Third International Edition - 03 (1 st, 2 nd and 3 rd printing) - Published 1999/2000/2001. Forth& Fifth International Edition 04/05 (First & second print) - Jan/July 2002/2003/2004. Sixth International Edition - 06 (1 st Edition Printing) - Publishing Date - January 2005 Published and distributed in UK, US, EU, Israel, Asia, and Japan in by Locum International Publishing House (Houston, Israel, South Africa) in Soft and Spiral Cover; Electronic CD ROM and Online Editions. Print and electronic editions are identical in format and content. Seventh International Edition - 07 (1 st International Printing) - Publishing Date-January 2006 Eighth International Edition - 08 (1 st International Printing) - Publishing Date-January 2007 Ninth International Edition - 09 (1 st International Printing) - Publishing Date-January 2008 Tenth International Edition - 10 (1 st International Printing) - Publishing Date-January 2009 Copyright Text Copyright Illustration copyright Locum International Group Publishing House 562 Monaco L Monaco Blvd., Delray Beach Florida USA. - All rights reserved ISSN ISSN Electronic Version (Online, CD ROM and PDF versions) Handbook Development 24 volume series General Generic Development ISSN Series number General Generic Development ISSN Series number Electronic Issue (Online and CD ROM are identical in size and content to the printed hard or soft cover version.) Duplication: No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise, without the prior written permission of the copyright owner or subject to the following conditions: Authorization to photocopy items for internal or personal use or internal or personal use of specific company personnel, is granted by Locum International Publishing House, provided that the base fee of $1 per page is paid directly to the Copyright Clearance Center (CCC) 222 Rosewood Drive, Danvers, MA USA. For organizations that have been granted a photocopy license by CCC, a separate system of payment has been arranged. For additional information, contact the Publications Department Locum International Publishing House; PO Box 874, 50 Gilad Street, Kochav Yair, Israel. Current Printing (last digit): US Fax: EU Fax: Global Orders Fax: info@iagim. org locumgroup. org locumeuro. com locumusa. com info@locumusa. com info@locumgroup. org SERIAL NUMBER - DO NO REMOVE! - REGISTERED WITH LOCUM INTERNATIONAL PUBLISHERS REGISTRATION SERVICES WARNING: THIS ISSUE A IS MULTIPLE PAGE UV ENCODED EDITION. PRINTED IN USA PRINTED IN ISRAEL PRINTED IN IRELAND PRINTED IN REPUBLIC OF SOUTH AFRICA
3 ORAL CAPSULE DOSAGE FORM Drug Development Handbook of Pharmaceutical Generic Development Series Compiled by : J.D. BLOCK BSc. MPS. D/PHARM. Research Director Generic & Innovative Drug Development Division Locum International Research Group. Science Editor - International Journal Series I. J. of Generic Drugs & I. J. of Drug Development School of Pharmacy University of the Witwatersrand Johannesburg RSA. Edited: IAGIM Scientific Committee Locum International Research Center Basel Switzerland Review Board: Generic & Innovative Drug Development Division Locum International Research Center Part I (Development) & Part II (Formulation -Development/ANDA) Part I (Development) & Part II (Formulation - Development/ANDA) Part I (Development) & Part II (Formulation -Development/ANDA) Part I (Development) & Part II (Formulation -Development/ANDA) Part I (Development) & Part II (Formulation-Development/ANDA) Part I (Development) & Part II (Formulation-Processes & ANDA) Part I (Development) & Part II (Formulation-Processes & ANDA) Part I (Development) & Part II (Formulation-Processes & ANDA) Part I (Development) & Part II (Formulation ; Processes & ANDA) Part I (Development) & Part II (Formulation-Processes & ANDA) Part I (Development) & Part II (Formulation-Processes & ANDA) Part I (Method Validation) & Part II (Analytical Methods ) Vol. 1 Vol..2 Vol. 3 VOL. 4 VOL. 5 VOL. 6 VOL. 7 VOL. 8 VOL. 9 VOL. 10 VOL. 11 VOL. 12 VOL. 13 Tablets IR Oral Capsules IR Oral Semisolids Topical Liquids Oral Soft Gelatin Capsules e-sops / SOPs Suspensions IR Oral Standard & Reconstituted Sterile Eye Preparations Nasal Preparations Oral Tablets CR / MR Oral Capsules ER Oral EC Tablets DR S I Assays HPLC 75 Stability Indicating Assays Handbook of Pharmaceutical INNOVATIVE Development VOL. 14 Tablets IR Oral Handbook of Pharmaceutical INNOVATIVE Development VOL. 15 Capsules IR Oral Handbook of Pharmaceutical INNOVATIVE Development VOL. 16 Suspensions IR Oral Handbook of Pharmaceutical DRUG Development (TITLE 17 SERIES Master Formula & Process Instructions) VOL. 17 MF & MMI Parts 1-5 Handbook of Pharmaceutical DRUG Development (TITLE 17 SERIES Master Formula & Process Instructions) VOL. 18 MF & MMI Parts 6-10 Handbook of Pharmaceutical DRUG Development Part I, II & III (Development, Manufacturing & Engineering VOL. 19 SOPs / PAI-Checklist Handbook of Pharmaceutical DRUG Development VOL. 20 Part I (Development) & Part II (Formulation ; Development & STERILE INJECTIONS ANDA) Part I (Development) & Part II (Formulation ; Processes & ANDA) VOL. 21 Chewable IR Tablets Available either as Soft Bound, Soft Spiral Cover (for Updating) or CD ROM. Additional Drug Specific Volumes in Preparation. An on-going electronic and print series For Drug Specific Handbooks refer to the 120+ Drug Development Series READY-TO-GO DRUG DEVELOPMENT CMC SERIES &
4 ORAL CAPSULE DOSAGE FORM Drug Development ISSN Handbook of Pharmaceutical G e n e r i c Development Part One Drug Development O RAL CAPSULES BLOCK J. D. & BELLE D. Copyright Locum Publishing House Inc. All Rights Reserved. ISSN 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 and retrieval system, without the permission of the publishers. Locum International Publishers
5 ORAL CAPSULE DOSAGE FORM Drug Development Acknowledgments I.A.G.I.M. (R&D) Foundation. I.A.G.I.M. Research Council. Contributions - Generic & Research Firms Associate Universities, Technicons and Consultants. Handbook Series Coordinating Committee. International Journal of Drug Development. International Journal of Drug Formulation. Journal of Pharmaceutical Development. International Journal of Generic Drugs. International Journal of Drug R&D I.A.G.I.M. Drug Development Archives Locum International Archives. FDA/OGD/CDER Maryland Guides and Guidelines Library of Congress. AIC Conferences. Editorial Board. Pharm. Eur. USP/NF. USPC. BP. To Doribelle for her years of support and help to Sean for his expert knowledge on computerization to David and Ari for running the project's computers and lastly to Pat for his inestimable contribution. 24 Volume Series International Edition LOCUM PUBLISHING HOUSE Published in Is, USA, UK & RSA
6 ORAL CAPSULE DOSAGE FORM Drug Development INTRODUCTION Handbook of Generic Development - Oral Capsule Dosage Form This handbook is the new expanded international edition of the ongoing 24 Volume under the cumulative title of Handbook of Pharmaceutical Generic Drug Development. It is a hands-on, technical presentation that portrays the current drug development requirements at the time of going to print necessary for an Abbreviated New Drug Application for an oral capsule dosage form. The Handbook is presented in two parts and is available in print, PDF electronic format. The e-format CD ROM is up-dated annually to association members of IAGIM as required. The alternative manufacturing methods in this application highlight the similarity of the wet granulation manufacturing process for encapsulation or dry granulation encapsulation (blending, slugging or roller compaction). The data that changes, for alternative processing procedures is simply the manufacturing, in-process and finished product specifications provided for in Sections 11 and 12 of Part Two of the Abbreviated New Drug Application. (Also available in EC dossier format with expert report and tabulations.) This new edition of the Handbook includes additional data on analytical method and finished product process validation has been redesigned to meet the latest Guidance for Industry - Organization of an Abbreviated New Drug Application as well as all key FDA guidelines and requirements of the Center of Drug Evaluation and Research (CDER) up to current edition date. Editor-in-Chief. International Edition LOCUM PRESS World wide distribution COPYRIGHT All Rights Reserved ISSN An on-going series Additional Volumes in Preparation General Drug Development Series ISSN Electronic Drug Development Series ISSN X
7 CONTENTS. Contents PHARMACEUTICAL DEVELOPMENT Table of Contents Acronyms - Abbreviations Introduction Preface Forward VIII XIII XVI XV XVI Chapter 1 Regulatory Pre-formulation checklist 1.2 Documentation SOP Control checklist 1.4 Development Notebooks Development Notebooks checklist SOP Control and Development Notebooks SOPs 1.7 Chapter 2 Developing the Formula -an Overview Formulation checklist Formula Development 2.3 Drug Development Checklist 2.4 Development formula SOPs 2.5 Developing the Formula 2.7 Purified Water - an ingredient 2.12 Product Development Guide 2.19 Chapter 3 Active Ingredients 3.1 -Do s and Don ts 3.2 -Active checklist - Approved suppliers 3.4 -Active checklist timeline 3.5 -Standard Operating Procedures, actives 3.6 -Active Ingredients - Approved suppliers SOP 3.7 handbooks@locumusa.com 24 Volume Drug Development Series handbooks@locumeuro.com
8 CONTENTS. Contents Chapter 4 Semi active ingredients 4.1 -Validating the semi active ingredients, checklist 4.2 Non active materials (excipients) 4.3 -checklist non active ingredient 4.4 Standard Operating Procedures, Non actives 4.5 Qualifying the semiactives 4.6 Semi active Tabulations 4.7 Qualifying of the antioxidant 4.11 The Reference Listed Drug 4.14 Chapter 5 Container closure systems 5.1 -Container-liner-closure systems, Checklist 5.2 -Container-liner-closure systems, SOPs 5.5 -Container-liner-closure systems - Flowchart 5.8 Chapter 6 Manufacturing Instructions Manufacturing Instructions; Checklist The Manufacturing Instructions and Controls The Manufacturing Process The Manufacturing Flow Charts The Manufacturing Controls Packaging Operation 6.25 Chapter 7 In-process Quality Controls 7.1 -Manufacturing in-process controls; Checklist 7.2 -Manufacturing in-process controls; What to Validate? 7.4 -In-process Quality Controls; SOPs 7.5 Chapter 8 Finished Product Specifications Finished Product Specifications; checklist Glossary of Terms and Specifications Finished Product Specifications; SOPs 8.7 handbooks@locumusa.com 24 Volume Drug Development Series handbooks@locumeuro.com
9 CONTENTS. Contents Chapter 9 Process Optimization 9.1 Qualification of Antioxidant and Preservatives 9.2 Qualification of finished Product Specification 9.3 Qualification of antioxidant and chelating Agent Limits 9.5 Optimization - Stability Studies 9.8 Chapter 10 Scale-up procedures Re-mixing & Processing Times Scale-up procedures; checklist Scale-up procedures; SOPs 10.5 Chapter 11 Cleaning Limits 11.1 Cleaning Limits Procedures; Checklist 11.6 Cleaning Validation Requirements; SOPs 11.7 Chapter 12 Analytical Validation Requirements Analytical Testing Out of Specification Analytical Testing Do's and Don'ts Ruggedness and Robustness Analytical Validation Agency Guidelines Chapter 13 Process Qualification Batch Process Qualification Batch; Checklist Process Qualification Batch; SOPs Process Qualification - Sampling Bias Process Qualification Sampling - Do's and Don'ts Process Qualification Protocol 13.8 handbooks@locumusa.com 24 Volume Drug Development Series handbooks@locumeuro.com
10 CONTENTS. Contents Chapter 14 Pivotal batch -The Pivotal Batch Pivotal batch Checklist Pivotal batch SOPs Sampling and Testing the Pivotal Batch Auditing the Pivotal batch Auditing the Pivotal batch Checklist Chapter 15 Bioequivalence vs. RLD 15.1 Topical Bioequivalence 15.2 Biostudy Graphs (Standard) 154. Diffusion Testing 15.7 SUPAC SS* 15.9 Chapter 16 Technical Transfer Documentation Technical Transfer Documentation; Checklist Technical Transfer Documentation; Pharmaceutical Part Technical Transfer Documentation; Analytical Part Chapter 17 Process Validation batches The Process Validation Batches; Checklist Process Validation Requirements; SOPs Process Validation Master Plan Process Optimization Master Plan 17.8 Chapter 18 Pre--Approval Inspections 18.1 Pre--Approval Summary Audit 18.8 Pre--Approval Team Set-Up 18.9 Pre--Approval Team Audit Activities Volume Drug Development Series
11 CONTENTS. Contents Chapter 19 Stability Testing of Drug Substance and Drug Product I 19.1 Stability Testing of Drug Substance and Drug Product II Stability Testing of Drug Substance and Drug Product II Stability Testing Significant Change Storage Conditions Setting up a functional Stability Unit Stability SOPs Development Chapter 20 Development SOPs 20.1 Index of Pharmaceutical Standard Operating Procedures 20.5 Index of Analytical Standard Operating Procedures 20.9 Index of Microbiological Standard Operating Procedures Index of Stability Standard Operating Procedures Ready-To-Go Drug Development Series ISSN X An on-going series Additional Volumes in Preparation Handbook of Pharmaceutical Generic Development Series ISSN Electronic Versions Handbook Development 24 Volume Series Series ISSN Number Electronic Version handbooks@locumusa.com 24 Volume Drug Development Series handbooks@locumeuro.com
12 CONTENTS. DRUG DEVELOPMENT Drug Development & Manufacture for Pharmaceutical Technology Professions H P G D Drug Development -Part I ANDA - Part II Copyright Locum International Ltd Update Program Part I and Part II: HandBook Generic Development Series Volume 1 Edition Volume 9 Edition Volume 2 Edition Volume 10 Edition Volume 3 Edition Volume 11 Edition Volume 4 Edition Volume 12 Edition Volume 5 Edition Volume 13 Edition Volume 6 Edition Volume 14 Edition Volume 7 Edition Volume 15 Edition Volume 8 Edition Volume 16 Edition Initiation Date : January 2006 Expiration Date : January 2008 No of Years : Three (3) Update Period : January 2006 ; to January This ANDA Drug Registration program has been updated to January 2005 Office of Generic Drugs requirements. Handbook clients requiring to continue this annual service need only to become members of I.A.G.I.M. for the period of the update service required by the firm. The ANDA Update Program is renewed in December each year as a function of the firms requirements. Warning: Copyright Locum Publishing House Inc. - All Rights Reserved. Neither this information nor any part of the data contained therein may be reproduced, copied or transmitted in any form, modification or merged portion or by any means, electronic or mechanical, including printing photocopying, microfilming and recording, or by any information storage and retrieval system, without the prior written permission of the publishers. Trademark - Locum Corporation, Locum International Group info@locumusa.com (See web site for IAGIM Membership Benefits / Application Forms and additional details) info@locumusa.com handbooks@locumusa.com 24 Volume Drug Development Series handbooks@locumeuro.com
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