Development & Mfg.

Ready-To-Go™

HANDBOOK OF PHARMACEUTICAL

GENERIC DEVELOPMENTPreapproval
Inspections

e-SOPs & PAI

Checklists
DEVELOPMENT & MANUFACTURE

HANDBOOKOFPHARMACEUTICALINNOVATIVE DEVELOPMENT

Innovative e-SOPs & PAI Checklists

Development & Mfg.

Development & Mfg.

Ready-To-Go™

Handbook of Pharmaceutical
Generic Development SeriesCompiled by :J. D. BLOCK
BSc. MPS. D/PHARM.
Research Director Generic & Innovative Drug Development Division, Locum International Group.
Science Editor - International Journal of Generic Drugs & International Journal of Drug Development
School of Pharmacy University of the Witwatersrand and Witwatersrand Technikon
Johannesburg RSA.

Edited:IAGIM Scientific Committee
Review Process :Generic & Innovative Drug Development Division
Research Center
Locum International Research

Volume 1
Volume 2
Volume 3
Volume 4
Volume 5
Volume 6
Volume 7
Volume 8
Volume 9
Volume 10
Volume 11
Volume 12
Volume 13
Volume 14
Volume 15
Volume 16
Volume 17
Volume 18
Volume 19

Part One
Part Two.
Part One
Part Two.
Part One
Part Two.
Part ThreePart One
Part Two.
Part One
Part Two.
Part One
Part One
Part Two.
Part One
Part Two.
Part One
Part Two.
Part One.
Part Two.
Part One
Part Two.
Part One
Part One
Part Two.
Part One
Part One
Part OnePart 1- 9
Part 1-9
Part One

Tablets / Caplets(Oral)
Development ANDA / EU Dossier - Tablets (plain, film & enteric)Capsules (Oral)
Development ANDA / EU Dossier - Oral Capsules
Topical Semi-solids (Creams, Ointments, Gels)
Development ANDA / EU Dossier - Topical Semi-solids
Development ANDA - Transdermal Delivery Systems
Oral Liquids / Reconstituted Liquids
Development ANDA / EU Dossier - Oral Liquids
Soft Gelatin Capsules (Oral)
Development ANDA / EU Dossier - Soft Gelatin Capsules
SOPs / e-SOPs - Drug Development
Oral Suspensions / Reconstituted Suspensions
Development ANDA / EU Dossier - Oral Suspensions
Eye/ Nose Preparations (liquids & sprays)
Development ANDA / EU Dossier - Eye / Nose Preparations
Inhalation Aerosols (Bucal / Nasal)
Development ANDA / EU Dossier - Inhalation Aerosols
Tablets / Caplets - Delayed & Extended Release
Development ANDA / EU Dossier - Tablets (Modified Release)
Capsules - Extended Release
Development ANDA / EU Dossier - Capsules - ER / DR
Innovative Development Semisolids
Analytical Methods and Method Validation
Analytical Methods Drugs from 1994 - 2003
Innovative Development Tablets (Oral)
Innovative Development Suspensions (Oral)
Innovative Development Capsules (Oral)
Innovative Development Master Formula
Innovative Development Manufacturing Processes
Innovative Development e-SOPs - PAI - Checklists

Available either as Hard Bound, Soft Bound or Soft Spiral Cover (for Updating).

4
Innovative e-SOPs & PAI Checklists

Development & Mfg.

Development & Mfg.

Ready-To-Go™

Electronic < Handbook Series of
Pharmaceutical Generic Development
ISBN 0793 8632 - Electronic Version
Handbook Development 24 Volume Series
ISSN Series Number 0793 761X - Electronic Version

Handbook of Pharmaceutical Generic Development

Vol. 1 - Tablets

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 2 - Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 3 - Semisolids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 4 - Liquids

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 5 - SG Capsules

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 6 - e-SOPs / SOPs.

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 7 - Suspensions

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 8 - Eye & Nose

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 9 - Aerosols MDIPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 10 -Tablets CR/MRPart I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development

Vol. 11 -Capsules ER

Part I (Development) & Part II (Model ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Handbook of Pharmaceutical Generic Development
Part I (Method Validation) & Part II (Analytical Methods 1994-2003)

Vol. 12 - Tablets Oral DR
Vol. 13 - Analytical(Top 50 Generic Assay Methods)

Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development

Vol. 14 - Tablets Oral
Vol. 15 - Capsules Oral

Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Drug Development (1-5)

Vol. 16 - Suspensions Oral
Vol. 17 - MF and MMI(Master Formula & Manufacturing Instructions Parts 1 - 5)

Handbook of Pharmaceutical Drug Development (6-10)

Vol. 18 - MF and MMI(Master Formula & Manufacturing Instructions Parts 6 - 10)

Handbook of Pharmaceutical Innovative Development

Vol. 19 - SOPs/PAI-Checklist

Part I, Part II & Part III.(Development, Manufacturing & Engineering)

Handbook of Pharmaceutical Drug Development

Vol. 20 - Sterile Injections

Available either on Online, CD ROM or via electronic mail attachment.
Additional Drug Specific Volumes in Preparation. An on-going electronic and print seriespp
ppp
Innovative e-SOPs & PAI Checklists

Development & Mfg.

Development & Mfg.

Ready-To-Go™

H ANDBOOK OF P HARMACEUTICAL
GENERIC DEVELOPMENTe-SOPs& PAI CHECKLISTSDevelopment, Manufacture & Engineering

Jeremy D. Block MPS D/Pharm.

VOLUME NINETEENFOURTH Edition.
2000

LOCUM
Locum Publishing House - Israel.

PUBLISHING

Locum Pharmaceutical Publishers - USA

Innovative e-SOPs & PAI Checklists

HOUSE
Locum International Publishers - Cape Town

Development & Mfg.

Ready-To-Go™

Development & Mfg.

Handbook of
Pharmaceutical GenericDevelopment
Locum International

Ongoing Series

SOPs&PAICHECKLISTS

Copyright © 2001 by Locum Publishing
House Inc. All Rights Reserved
Neither this book nor any part may be
reproduced or transmitted in any form or by
any means, electronic or mechanical,including photocopying, microfilming andrecording, or by any information storage
and retrieval system, without the permissionof the publishers.
Locum International Publishers

Innovative e-SOPs & PAI Checklists

A Locum House Publication Volume iXX

Development & Mfg.

Ready-To-Go™

Development & Mfg.

PAI CHECKLISTS, Volume Fourteen - First International Edition - Ed. 01.
First published and distributed in UK, US, EU, RSA, Israel and Japan in February 1995:
by Locum International Publishing House (Europe, Houston, Israel, South Africa).
Second International Edition - 02 (Reprinting run number #2 - 1996).
Third International Edition - 02 (Reprinting run number #3 - 1998).
Fourth International Edition - 02 (Reprinting run number #4 - 2000).
Published and distributed in UK , US, EU, Israel, Asia and Japan in June 1997:
by Locum International Publishing House (Houston, Israel, South Africa).
Copyright © 2001 - Handbook of Pharmaceutical Generic Development -PAI CHECKLISTS
Copyright © 1997 - Handbook of Pharmaceutical Generic Development -PAI CHECKLISTS
Copyright © 1996 - Handbook of Pharmaceutical Generic Development -PAI CHECKLISTS
Copyright © 1995 - Handbook of Pharmaceutical Generic Development -PAI CHECKLISTSText Copyright © 1994 - Handbook of Pharmaceutical Generic Development -PAI CHECKLISTS
Illustration copyright © 1994 - Handbook of Pharmaceutical Generic Development
Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864 Israel.
All right reserved.
ISSN Series 0793 7601 - Handbook of Pharmaceutical Drug Development Series
ISSN Series 0793 761X - Electronic Disc Version

Duplication: No part of this publication may be reproduced, stored in a retrieval systemor transmitted in any form or by any means, electronic, mechanical, photocopying,microfilming, recording or otherwise, without the prior written permission of the copyrightowner or subject to the following conditions:
Authorization to photocopy items for internal or personal use or internal or personal useof specific company personnel, is granted by Locum International Publishing House,provided that the base fee of $3 per page is paid directly to the Copyright ClearanceCenter (CCC) 222 Rosewood Drive, Danvers, MA 01923 USA. For organizations thathave been granted a photocopy license by CCC, a separate system of payment has beenarranged.
For additional information, contact the Publications Department Locum International
Publishing House; PO Box 874, 50 Gilad Street, Kochav Yair, 44864 Israel.
UK Fax: +(44) 207-900 2096
US Fax: +(1) 435-408 1665
Fax: +972-97-494 532

E-mail: info@locum. co. il
http://www.locum.co.il
http://www.locumeuro.com
http://www.locumusa.com
handbooks@l o c u m u s a . com
sales@l o c u m u s a . com

Current Printing (last digit):
SERIAL NUMBER - DO NO REMOVE! - REGISTERED WITH
109 8 7 6 5 4.
LOCUM INTERNATIONAL PUBLISHERS REGISTRATION SERVICESWARNING: THIS ISSUE A IS MULTIPLE PAGE UV ENCODED EDITION.

Innovative e-SOPs & PAI Checklists

Ö PRINTED IN USA
PRINTED IN ISRAELPRINTED IN IRELAND
PRINTED IN REPUBLIC OF SOUTH AFRICA

Development & Mfg.

Development & Mfg.

Ready-To-Go™

Acknowledgments
I.A.G.I.M. (R&D) Foundation.
I.A.G.I.M. Members (1994 - 2000).
Contributions - Generic & Research Firms
Associate Universities, Technicons and Consultants.
Handbook Series Coordinating Committee.
International Journal of Drug Development.
Journal of Pharmaceutical Development.
International Journal of Generic Drugs.
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 computersand lastly to Pat for his inestimablecontribution.

Fourth International Edition.
2001

L O C U M

P U B L I S H I N G

H O U S EpppÏÐÍ°Î

Innovative e-SOPs & PAI Checklists

Development & Mfg.