A comprehensive review and best practice guidance:
Bio-contamination Characterisation, risk profiling, control, monitoring and deviation management.
Prepared by a PHSS special interest group from the pharmaceutical industry, NHS, Suppliers and specialist consultants.
Reviewed by the MHRA.
Applies to controlled environments in GMP and non sterile applications where Bioburden control is required.
Overview of content
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).