Sunday 10 November 2013

Bicontamination: New PHSS Technical Monograph

The PHSS (Pharmaceutical and Healthcare Sciences Society) have issued a monograph on biocontamination control: PHSS Technical Monograph No 20 (2013).

The monograph was put together by a team of healthcare and pharmaceutical professionals (Pharmaceutical Microbiology’s Tim Sandle was part of the team). The monograph has been reviewed by the U.K. regulatory inspection agency, the MHRA.

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).

For further details, see the PHSS

Posted by Tim Sandle

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