Clean Air and Containment Review
The journal to enhance your knowledge of cleanroom, clean air and containment technology
Editor: John Neiger
Publisher: Euromed Communications
Site design:
Fourwest Media
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Guidelines

Note: We have listed links to sites from which guidelines can be obtained as well as direct links to the most relevant individual guidelines (indented). The majority of these are free downloads.

The EU GMP, PIC/S, ICH and WHO guidelines are referred to in Dr Hans Schicht's 'Regulatory Reflections' column in Clean Air and Containment Review.

The UK NHS Aseptic guidance documents are interesting in that they fill some of the gaps in international ISO cleanroom standards. These documents were previously restricted to UK NHS users.

The UK Health and Safety Executive (HSE)/Advisory Committee for Dangerous Pathogens (ACDP) documents include useful categorisations of biological agents and of containment facilities.

PDA

PDA Technical Reports
PDA Technical Report 51 (TR51): Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use NEW

DECC (Department of Energy & Climate Change)

DECC Publications Library
PDF icon The Carbon Reduction Commitment User Guide

European Good Manufacturing Practice

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines
PDF icon EU GMP Annex 1:2008: Manufacture of Sterile Medicinal Products

PIC/S

Pharmaceutical Inspection Cooperation Scheme (PIC/S)
PDF icon GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS

ICH Guidelines

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
PDF icon Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)
PDF icon Q9: Quality Risk Management
PDF icon Q10: Pharmaceutical Quality System

WHO

WHO Good Manufacturing Practices
PDF icon Quality assurance of pharmaceuticals
PDF icon WHO Technical Report Series 957, WHO Expert Committee on specifications for pharmaceutical preparations, Forty-fourth report

UK NHS

Aseptic guidance documents ('Yellow cover documents') on the Technical Specialist Education and Training (TSET) web site
PDF icon Clean room garment monitoring 3 - John Rhodes Publication version FEB 06
PDF icon Micro Protocol - Cleaning and Disinfection Regimes for Clean Rooms Vers 3 Final 3 25.02.08
PDF icon Monitoring of Isolators and Enclosed Spaces Sterilised by Hydrogen Peroxide Vapour Aug 09
PDF icon Sampling Programme For GMP Environments Final Version
PDF icon DOP test protocol final version April 08

PHSS

PHSS Technical Monographs
No.2 (revised 2002): Environmental Contamination Control Practice
No.14 (2005): Risk Management of Contamination (RMC) During Manufacturing Operations in Cleanrooms
No.16 (2008): Best Practice for Particle Monitoring in Pharmaceutical Facilities

ISPE

ISPE Bookstore
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

IEST

Contamination Control Recommended Practices

US FDA

PDF icon FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice: 2004

US Pharmacopeia

US Pharmacopeia
USP <797> Guidebook to Pharmaceutical Compounding - Sterile Preparations

CETA

Controlled Environment Testing Association (CETA)
PDF icon Compounding Isolator Testing Guide

ASHP

American Society of Health-System Pharmacists
Compounding Sterile Preparations

GAMP®5

GAMP®5 Guide and the GAMP series of Good Practice Guides

UK ACDP

Advisory Committee on Dangerous Pathogens
The management, design and operation of microbiological containment laboratories

US NIH

NIH Guidelines
PDF icon NIH Guidelines for research involving recombinant DNA Molecules