Editor: John Neiger
Publisher: Euromed Communications
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)
European Good Manufacturing Practice
- EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines
EU GMP Annex 1:2008: Manufacture of Sterile Medicinal Products- EU GMP Annex 1: Manufacture of Sterile Medicinal Products, December 2017 draft for consultation
PIC/S
- Pharmaceutical Inspection Cooperation Scheme (PIC/S)
- 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)
- Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)
- Q9: Quality Risk Management
- Q10: Pharmaceutical Quality System
WHO
- WHO Good Manufacturing Practices
- Quality assurance of pharmaceuticals
- 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
- Clean room garment monitoring 3 - John Rhodes Publication version FEB 06
- Micro Protocol - Cleaning and Disinfection Regimes for Clean Rooms Vers 3 Final 3 25.02.08
- Monitoring of Isolators and Enclosed Spaces Sterilised by Hydrogen Peroxide Vapour Aug 09
- Sampling Programme For GMP Environments Final Version
- 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
US FDA
US Pharmacopeia
CETA
ASHP
GAMP®5
UK ACDP
- Advisory Committee on Dangerous Pathogens
- The management, design and operation of microbiological containment laboratories