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Table of Contents.

CONTENTS
PHARMACEUTICAL
Table of Contents
Acronyms - Abbreviations Introduction Preface Forward

DEVELOPMENT
VIII XIII XV XVI XVII

Chapter
Regulatory
- Pre-formulation checklist

1
1.1 1.3 1.4 1.6 1.7 1.9 1.10

Documentation
- SOP Control checklist Development Notebooks - Development Notebooks checklist - SOP Control and Development Notebooks SOPs

Chapter
Developing the Formula -an Overview

2
2.1 2.2 2.3 2.5 2.6 2.7 2.12 2.13 2.21 2.27 2.29 2.35 2.33 2.38 2.46 2.54

- Formulation checklist - Development formulations - sterile preparations Drug Development Checklist Development Formula SOPs Developing Sterile Formulations Design Considerations for Sterile Formulations Product Development data - Case Histories Product Development Guide and tabulations Product Development Flowchart Developing Sterile Preparations Sterile Formulations Master Formulations Purified Water - an essential ingredient Development - Paclitaxel Purified Water - Checklist Aseptic processing guidelines

Chapter
Active Ingredients
-Dos and Donts -Active checklist -Approved Suppliers Checklist -Alternative API Suppliers - Actives
Handbook of Pharmaceutical

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3.1 3.2 3.3 3.5 3.7
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Generic Development

Table of Contents.

Contents
Chapter
Semi active ingredients
-Validating the Semi-active ingredients, Checklist Non active materials (excipients) -Checklist non active ingredient -Standard Operating Procedures, Non actives

4
4.1 4.2 4.3 4.5 4.6

Chapter
Container closure systems

5
5.1 5.3 5.4 5.5 5.11 5.12 5.16

-Container-closure systems, Checklist -Container-closure systems, SOPs -Packaging Components - Documentation Requirements -Packaging Components - Description and Characteristics -Packaging Components Documentation Requirements SOP -Packaging Components - Compendial Test Requirements

Chapter

6
6.1 6.2 6.4 6.6 6.10 6.23 6.20 6.33 6.35

Manufacturing Instructions & in-process controls


Production In-process controls Quality Control In-process Testing Schedule - Manufacturing & Controls - Sampling procedures - The manufacturing Instructions and Controls - Manufacturing Flow Charts - Fill Weight Verification - Fill Weight Verification Tabulations - Packaging trail and Disbursements

Chapter
In-process Quality Controls

7
7.1 7.2 7.5

-Manufacturing in-process controls; Checklist -In-process Quality Controls; SOPs

Chapter

8
8.1 8.2 8.4 8.9 8.12

Finished Product Specifications - Finished Product Specifications example and Checklist


- release Specifications - Glossary and Terms - Finished Product Specifications; Required SOPs

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Generic Development

Table of Contents.

Contents
Chapter
Process Optimization and Procedures
Evaluation Product Specifications Qualification of Preservative and Chelating Agent Qualification of Preservative and Chelating Agent - Stability studies

9
9.1 9.3 9.4 9.6

Chapter
Scale-up Procedures
- Scale-up procedures; checklist - Scale-up procedures; SOPs

10
10.1 10.4 10.5

Chapter
Cleaning Limits

11
11.1 11.6 11.9

Cleaning Limits Procedures; Checklist Cleaning Validation Requirements; SOPs

Chapter

12
12.1 12.39 12.48 12.49 12.51 12.62 12.63 12.64 12.67 12.67

Analytical Validation Requirements -Analytical Testing Out of Specification -Analytical Testing Outliers -Out of Specification -Impurities in Drug Substances -Impurities Glossary of terms -Impurities Do's and Don'ts -Impurities Decision Trees Analytical Post approval Changes -PAC-ALTS PAC-ALTS Checklist

Chapter
Process Qualification Batch

13
13.1 13.2 13.3 13.5 13.7 13.10 13.14

-Process Qualification Batch; Checklist -Process Qualification Batch; SOPs -Process Qualification Blend Analysis -Process Qualification Blend Analysis - Do's and Don'ts -Ruggedness and Robustness -Process Qualification - Qualifying Bulk Solutions - Protocol

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Generic Development

Table of Contents.

Contents
Chapter
Pivotal batch
-Pivotal batch Checklist -Sampling and Testing the Pivotal Batch - solution reconstitution -Auditing the Pivotal batch -Auditing the Pivotal batch Checklist

14
14.1 14.2 14.5 14.11 14.13

Chapter Chapter
Technical Transfer Documentation TTD Contents

15
15.1

Exclusion of Biostudy Testing - Sterile Solutions

16
16.1 16.2 16.5 16.7 16.10

-Technical Transfer Documentation; checklist -Technical Transfer Documentation; Pharmaceutical Part -Technical Transfer Documentation; Analytical Part

Chapter
Process Validation Plan

17
17.1 17.2 17.4 17.5 17.7 17.8 17.14 17.18 17.32 17.36 17.44 17.48 17.54 17.58 17.64 17.68 17.72 17.76 17.82 17.88 17.92 17.96 17.99

-The Process Validation Batches; checklist -Process Validation Requirements; SOPs -Process Validation Master Plan -Process Optimization Master Plan -Process Validation, Stability and Statistics -Validation Protocol - bulk sterile solutions17.14Validation Check List -Installation and operational qualification -Prospective Validation Protocol - sterile Cefuroxime Sodium -Prospective Validation Protocol - Lyophilized Vancomycin HCl -Prospective Validation Protocol - Aciclovir Sodium for IV infusion -Validation Check List - Purified water USP -Validation Check List - WFI System -Validation Check List - Pure Steam System -Validation Check List - Compressed Air System - Validation Check List -Washing Machine System - Validation Check List - Sterile Nitrogen System - Validation Check List - Autoclave - Validation Check List - Dry heat Oven - Validation Check List - Lyophilizer - Validation Check List - Sterilizing Tunnel - Validation Check List - Equipment and machines - Validation Check List - HVAC System
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Table of Contents.

Contents
Chapter 18
18.1 18.5 18.7 18.8 18.9 18.11 Pre--Approval Inspections & Failures PAI Audits PAI Mock Inspections PAI Summary Pre--Approval Inspection Audit - Team Set Up Pre--Approval Inspection Audit - Team Activities

Chapter

19
19.1 19.15 19.21 19.24 19.29 19.31 19.39

Stability Testing of Drug Substance and Drug Product I 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
20.1 20.5 20.9 20.16 20.21

Standard Operational Procedures Development SOPs


Index of Pharmaceutical Standard Operating Procedures Index of Analytical Standard Operating Procedures Index of Microbiological Standard Operating Procedures Index of Stability Standard Operating Procedures

ISSN 0793 8632

An on-going series Additional Volumes in Preparation

ISBN 0793 8640 - Electronic Version Handbook Development 24 Volume Series ISSN Series Number 0793 7792 - Electronic Version

Handbook of Pharmaceutical Generic Development Series

Handbook of Pharmaceutical

Generic Development

Table of Contents.

HPGD

Handbook of Pharmaceutical Generic Development

Drug Development - Part I ANDA Formula - Part II


Copyright 1995 -2004 Locum International Ltd.

2006-7 Update Program


Part I and Part II: HandBook Generic Development Series
Update License No:

1.3.02-000

Initiation Date : Expiration Date : No of Years : Update Period :

January 2006 January 2007 One (1) January 2006 to January 2007.

This Drug Development ANDA has been updated to January 2006 Office of Generic Drugs requirements. Handbook clients with multiple handbooks 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. Standard Plan (one year) IAGIM members may purchase the update with the adjacent form.
Warning: Copyright 1985 -2006 Locum Publishing House Inc. - All Rights Reserved. Neither this information or 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 Application Membership form) info@locumGroup.org http://www.locumGroup.org

Handbook of Pharmaceutical

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