药品生产设备设计标准指南：第2版

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.

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

• 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