Guide to Good Validation Practice, 3rd Edition

Published by: Drug and Market Development Publishing

Published: Aug. 15, 2007 - 213 Pages

Table of Contents

Chapter 1: Executive Summary

Chapter 2: Introduction

Validation in Research, Development, and Manufacturing

The Regulatory Environment

Types of Validation

Corporate Implications of Non-compliance with GVP

Chapter 3: The Validation Master Plan

Introduction

Validation Master Plan Contents

Responsibilities

What is to be Validated?

Facilities

Systems

Processes

Analytical Methods

Implementing the Plan

Design, Installation, and Operational Qualification

Performance Qualification and Validation

Documentation

Change Control

Chapter 4: Facilities, Services, and Systems

Facilities

Design and Construction

Utilities

Validation of Special Systems

Water Systems: Purified and WFI

Sterilization Systems and Clean Steam Systems

Clean Rooms—Aseptic Work Areas

Computerized Systems

Chapter 5: Process Equipment and Pipe-work

Introduction

Design and DQ of Equipment and Piped Systems

Installation, Operation, and Performance Qualification

Validation of Cleaning Procedures

Validation of Sterilization-In-Place Procedures

Chapter 6: Manufacturing Processes

General Principles of Process Validation

Guide to the Performance of Validations

Special Processes—Validation Challenges

Glassware Washing Machines

Fermentor and Bioreactor Control

Chromatographic Separation

Transverse-flow Micro- and Ultrafiltration

Sterilizing Filtration

Virus Removal Processes

Aseptic Filling Operations

Lyophilizer (Freezedryer) Operation

Chapter 7: Analytical Methods for In-process and Final Quality Control

Regulatory Requirements and Guidelines

Qualification of Analytical Instruments and Equipment

Test Method Validation

Types of Analytical Procedures to be Validated

Test “Verification”, “Qualification” versus “Validation”

Physical and Chemical Analyses

Biological Assays

Chapter 8: Sample Checklists and Forms

Check Lists for Plans and Protocols

Equipment Qualification Report Forms

Chapter 9: References and Further Reading

Access to Regulations on the Internet

Validation and GMP Compliance Guidelines

U.S.A

Canada

European Union

International Conference on Harmonization (ICH)

Associations, Consultants and Publications

Chapter 10: Abstracts from International GLP/GMP/GCP Regulations

Good Laboratory Practice

OECD PRINCIPLES OF GOOD LABORATORY PRACTICE*

(as revised in 1997)

USA Code of Federal Regulations

CANADA - “Guidelines for Good Manufacturing Practice”

JAPAN MHW Ordinance 16, March 123, 1999, Amended by MHW Ordinance #95, May 20, 2003.

Chapter 11: Text of Key Validation Guidelines

Process Validation Guidelines

TABLE OF EXHIBITS

Exhibit 2.1 Definitions of “Process Validation”

Exhibit 2.2 The Drug Development Cycle

Exhibit 2.3 International "Practice" Regulations

Exhibit 2.4 Regulations Specifically Concerning Validation

Exhibit 2.5 Process Validation and the Product Development Cycle

Exhibit 3.1 Typical “System Definition” Table for a VMP

Exhibit 3.2 Derivation of Validation Plans/Protocols

Exhibit 3.3 Validation Protocol Contents List

Exhibit 4.1 Factors Determining User Requirements Specifications

Exhibit 4.2 Standards for Pharmaceutical Water Grades

Exhibit 4.3 Schematic of WFI System

Exhibit 4.4 Clean Room Classes According to FS 209E

Exhibit 4.5 EUDRA Clean Room Specifications

Exhibit 4.6 ISO 14644-1 Standard

Exhibit 4.7 EU Microbiological Monitoring of Clean Areas

Exhibit 6.1 Validation and Product Development

Exhibit 6.2 Process Validation Life Cycle

Exhibit 6.3 Terminology of Process Validation

Exhibit 6.4 Calculation of Process Capability

Exhibit 6.5 Washer Qualification Plan

Exhibit 6.6 Control of a Cell Culture Bioreactor

Exhibit 6.7 Typical Flow/Pressure Graphs for TFF Membranes

Exhibit 6.8 Parameters Affecting Sterilizing Filter Performance

Exhibit 6.9 Viruses Commonly Used in Clearance Studies

Exhibit 7.1 Basis of Questionnaire for Vendor Qualification

Exhibit 7.2 The Characteristics of a Calibration Curve

Exhibit 7.3 Parameters Applicable to Different Analytical Procedures

Exhibit 7.4 Analytical Methods Applied to Biological Products

Exhibit 7.5 Calculation of Intra-assay and Inter-assay Precision

Exhibit 7.6 Three-dimensional Factorial Test Validation Plan

Exhibit 11.1 FDA Guideline on General Principles of Process Validation

Exhibit 11.2 EU European Commission

Exhibit 11.3 ORA Compliance Policy Guide

Exhibit 11.4 Guidance to 21CFR11

Exhibit 11.5 FDA/ICH Analytical Method Validation Q2A & B

Exhibit 11.6 FDA Bioanalytical Method Validation

Abstract

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.