PMF Newsletter September 2012

This issue presents a unique perspective offered by Tony Luttrell on QC Microbiology laboratories.

Also in this issue Dr. Tim Sandle returns with an article summarizing the proposed revision to the European Pharmacopeia chapter on biological Indicators.

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PMF Newsletter February 2012

This issue presents an approach to the qualification of a contract microbiology laboratory, authored by Dr. Scott Sutton. Several regulatory documents of use are presented and summarized in “real world” terms.

In addition, Dr. Barry Friedman presents an excellent summary of current CMO issues. This is currently an area of much attention and discussion and we are sure you will enjoy this overview.

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PMF Newsletter January 2012

This issue presents a White Paper which provides several regulatory and industry references on the importance of including in-house microbial isolates in compendial testing. For some areas, this has been a long-standing expectation as evidenced by regulatory actions and guidances. For others, we are beginning to see an increasing regulatory expectation.

Dr. Tim Sandle provides a survey of some of the recent developments in European regulatory requirements that have taken place in 2011, including pharmacopoeial changes and inspectorate guidelines. Dr. Sandle has expertly summarized changes that are of interest to pharmaceutical microbiologists.

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