GMP News - Aseptic / Microbiology

20.06.17

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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20.06.17

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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20.06.17

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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24.05.17

Recent FDA Warning Letter: Issues with Monitoring of microbiological Environments

Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.

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17.05.17

Warning Letter for Brazilian Manufacturer of Antibiotics

In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.

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30.03.17

Warning Letter for Japanese Sterile Manufacturer

Insufficient environmental monitoring as well as inexistent smoke studies on a RABS (Restricted Access Barrier System) resulted in a Warning Letter for the Japanese manufacturer Sato Pharmaceutical Co. Ltd.

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25.01.17

Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.

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13.12.16

Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 1

Following serious GMP violations, the American FDA issued an unusually severe Warning Letter to a Hungarian company in October 2016. Severe also because the authority put the company on the list of import bans until the defects have been fixed. Learn more about the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private.

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25.10.16

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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25.10.16

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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31.08.16

Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 3

Once again, the American FDA has addressed a Warning Letter to an Indian Manufacturer of sterile medicinal products. Major and serious violations of GMP principles were identified at the Indian Manufacturer Emcure Pharmaceuticals Limited. Part 3 of this news will deal with the issue of insufficient documentation. You will find more information on the most important deficiencies in this Warning Letter here.

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28.07.16

EDQM announces revision of general chapter Monocyte Activation Test (2.6.30)

On 23 June, the EDQM in Strasbourg announced the revision of the pharmacopoeial general chapter 2.6.30 on Monocyte Activation Test.

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28.07.16

EDQM Survey on new General Chapter on microbiological Control of Tissue

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.

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26.07.16

New Orientation for ECA Foundation RMM Working Group

The ECA Foundation's Rapid Microbiological Methods (RMM) Working Group was originally established in June 2006 at the Paul-Ehrlich-Institut (PEI) - the German Federal Agency for Vaccines and Biomedicines. Now the Foundation announced a new orientation for its RMM Working Group.

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26.07.16

Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".

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