Guide to Good Facility Design, 2nd Edition

Published by: Drug and Market Development Publishing

Published: Aug. 15, 2007 - 124 Pages

Table of Contents

Chapter 1: Executive Summary

Chapter 2: Introduction

National and International Regulations

Enforcement of the Regulations

Chapter 3: Types of Facility Subject to Regulations

Product Development and Testing Laboratories

Animal Facilities

Manufacturing Facilities

Chapter 4: Common Design Factors in Regulatory Requirements

Cleanliness

Logical Workflow

Adequate Space and Lighting

Adequate Separation of Different Processes and Functions

Dealing with the Common Factors

Chapter 5: Special Design Requirements

Systems for Purified Air, Water, Steam, and Gases

Air

Water

“Clean Steam”

Process Gas Supply

Containment of Hazardous and Infectious Materials

Biosafety Levels

Primary Containment Equipment

Secondary Containment for Larger Scale Operations

Facilities for Aseptic Operations

Systems for the Sterilization of Equipment, Products, and Effluents

Batch Sterilization

Continuous Service Sterilizers

Effluent Treatment

Animal Facilities

Chapter 6: National and International Codes and Standards

Classification of Pathogens

Bacteria

Viruses

Fungi

Parasites

Classification of Cleanroom Air

Water Purity Standards

Chapter 7: Abstracts from Relevant Regulations

Good Laboratory Practice (GLP)

21CFR58 Subpart C--Facilities

Sec. 58.41 General.

Sec. 58.45 Animal supply facilities

Sec. 58.47 Facilities for handling test and control articles.

Sec. 58.49 Laboratory operation areas.

Sec. 58.51 Specimen and data storage facilities.

OECD Principles of GLP, 1998 - ENV/MC/CHEM(98)17

§3. Facilities

Good Manufacturing Practice

21CFR211, 2006

§ 211.42 Design and construction features.

§ 211.44 Lighting

§ 211.46 Ventilation, air filtration, air heating and cooling.

§ 211.48 Plumbing

§ 211.50 Sewage and refuse

§ 211.52 Washing and toilet facilities

§ 211.56 Sanitation

§ 211.58 Maintenance.

21CFR600 - Biological Products, General

Sec. 600.11 Physical establishment, equipment, animals, and care

Canada GMP Regulations & Guidelines, 2002

Canada GMP for Biologicals, 2002

EUDRA Volume 4, 2003

Chapter 3: Premises & Equipment

EUDRA Volume 4, Annex 1, Manufacture of Sterile Products

EUDRA Volume 4, Annex 2, Manufacture of Biological Medicinal Products for Human use

ICH Guidelines for Manufacture of APIs (FDA Version, 2002)

Chapter 8: Guidelines and Other References

ISPE Guides

FDA Guidances

The Centers for Disease Control & Prevention & NIH

Canada: Public Health Agency Laboratory Biosafety Guidelines

The USA Department of Agriculture

The Parenteral Drug Association

Cleanroom Publications

Other Books

TABLE OF EXHIBITS

Exhibit 2.1 GLP/GMP Regulations Governing Facility Design

Exhibit 2.2 Stages of Drug Development

Exhibit 4.1 Schematic Floor Plan for a Pharmaceutical Plant (Oral and Topical Products)

Exhibit 4.2 Schematic Layout of a Vaccine Production Plant

Exhibit 4.3 Layout of an Aseptic Fill/finish Plant

Exhibit 4.4 Example of a Bubble Diagram

Exhibit 4.5 Floor Layout of a Cell Culture Production Unit

Exhibit 4.6 Layout for a Large-Scale Fermentation Set-up

Exhibit 5.1 Separating Reactor Operations by Air Flow

Exhibit 5.2 USP and EP Water Standards

Exhibit 5.3 WFI Circulating System - Schematic

Exhibit 5.4 Examples of Clean Steam Traps

Exhibit 5.5 Example of a Clean Steam Generator Layout

Exhibit 5.6 Summary of Recommended Biosafety Levels for Infectious Agents

Exhibit 5.7 Biosafety Levels Applied to Some Common Microorganisms

Exhibit 5.8 Classification of Class II BSC

Exhibit 5.9 Biological Safety Cabinet, Class II Type A

Exhibit 5.10 Biological Safety Cabinet Class II, Type B1

Exhibit 5.11 FDA Classification, Using Federal Air Quality Standard 209E

Exhibit 5.12 Generally Accepted Levels for Different Work Areas

Exhibit 5.13 ISO Typical Cleanroom Classifications

Exhibit 5.14 Types of Cleanroom Air Flow

Exhibit 5.15 Cleanroom Layout, showing Air Classifications

Exhibit 5.16 Section Through a BL 2/3 Aseptic Suite

Exhibit 5.17 Two Glove-Port Isolators

Exhibit 5.18 “Half-Suit” Isolator

Exhibit 5.19 Installation Plan for a Production Autoclave

Exhibit 5.20 Autoclave Loading Cart

Exhibit 5.21 Autoclave Effluent Sterilizing System

Exhibit 5.22 Floor Layout of a Containment Animal Unit

Exhibit 6.1 Biohazard Risk Groups for Bacteria

Exhibit 6.2 Biohazard Classification of Some Arboviruses

Exhibit 6.3 Classification of More Commonly-Encountered Viruses

Exhibit 6.4 Biohazard Classification of Fungi

Exhibit 6.5 Classification of Common Parasites

Exhibit 6.6 Cleanroom Classes According to FS 209E

Exhibit 6.7 European Union Air Grade Classification

Exhibit 6.8 Examples of Operations for Non-terminally Sterilized Products

Exhibit 6.9 Recommended Limits for Microbial Monitoring of Cleanrooms

Exhibit 6.10 Graphical Representation of ISO Air Classes

Exhibit 6.11 ISO Cleanliness Classes

Exhibit 6.12 Clean Air Handling Criteria

Exhibit 6.13 Tables for Water Conductivity Measurement

Exhibit 6.14 Water Quality Acceptable for Various Sterile Products

Exhibit 8.1 Canadian Check Lists

Abstract

Drug regulatory agencies require pharmaceutical and biopharmaceutical establishments to comply with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations. D&MD's Guide to Good Facility Design, 2nd Edition examines these regulations and details the means whereby a facility design that is in compliance with them can be achieved economically and efficiently

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