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Guidance on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing

The ECA Pharmaceutical Microbiology Working Group completed the first chapter of their guidance on handling of microbiological deviations to support members in dealing with OOS and OOL results.

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FDA Warning Letter relating to the Use of an alternative microbiological Method

The FDA issued a Warning Letter objecting to inadequate microbiological testing and product contamination with Burkholderia Cepacia and other microorganisms and following adverse events. Find out more abou the FDA Warning Letter.

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Burkholderia cepacia - FDA Advice on Contamination Risk

Recent recalls determined FDA advice to drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products.

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Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated  the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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Revisions of EP Chapter 5.1.8, 2.6.36, 2.6.38 and Monograph 3053

In April, the Pharmeuropa issue 29.2 was completed including the revision of chapter 5.1.8. "Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts Used in their Preparation".

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FDA Guidance for Blood Donations with regard to Ebola Virus published

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".

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ICH M9: Biopharmaceutics Classification System-based Biowaivers

In October 2016, the International Council for Harmonisation (ICH) endorsed a new topic for the development of a new multidisciplinary guideline M9. Read more about Biopharmaceutics Classification System (BCS)-based biowaivers.

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FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

To assist pharmaceutical manufactureres in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation".

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Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus

The FDA published the final version of the Guidance for Industry" Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

An FDA investigation associated with a multistate outbreak has identified the bacteria Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured. More details at the FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections.

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