Thursday, 9 October 2014

PHSS bio-contamination monograph

The PHSS have produced a comprehensive monograph on bio-contamination in pharmaceutical and healthcare environments. The monograph examines bio-contamination characterisation, environmental control, environmental monitoring, deviations, and practices in GMP and classified areas.

The contents are:

Section 1. Introduction and scope includes a review of the challenges and requirements for Bio-contamination control and cross contamination control with a holistic approach to monitoring and proactive investigations in response to increased risk from changes in biocontamination profiles.

Section 2. Bio-contamination characterisation and risk profiling. Methodologies and strategies that profile bio-contamination through establishing control, in operations and holistic monitoring.


Section 3. Bio-contamination control principles and best practice guidance considering Quality by Design, different processes, control attributes, background environments and Barrier technologies.

Section 4. Bio-contamination monitoring including classical and Rapid Micro Methods (RMM).

Section 5. Bio-contamination Deviation management including considerations and guidance in completing investigations and undertaking corrective and preventative actions (CAPA).

The document was developed by James Drinkwater, Andrew Hopkins, Mike Davies, Ian Symonds, Tim Sandle, Tim Eaton, Una Hearty, Jim Filer, Malcolm Homes and Tim Triggs. Peer review was undertaken by a number of industry experts. The review included the U.K. regulatory inspection agency, the MHRA.

The document is reference is:

PHSS (2014) Bio-contamination, Technical Monograph No. 20, Pharmaceutical and Healthcare Sciences Society, Wiltshire, U.K.

For further details, see: PHSS

Posted by Tim Sandle

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