| 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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- 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
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