GMP News - Aseptic / Microbiology

27.09.17

Frequently asked: What does the Exposure Time of Disinfectants mean?

The question after the meaning and the handling of indicated exposure times of disinfectants is asked again and again.

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20.09.17

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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13.09.17

EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.

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30.08.17

EMA publishes final Version of Q&A Paper on Production of "cold" WFI

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.

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23.08.17

EMA non-compliance report on Brazilian manufacturer of sterile medicinal products

During an inspection, the french authorities found major deficiencies at the site of a Brazilian manufacturer of sterile medicinal products. Learn more details about the EMA's non-compliance report.

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16.08.17

Non-Compliance Report for manufacturing of three Products at Biocon, India

The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.

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26.07.17

EMA non-compliance report on Indian manufacturer of sterile medicinal products

During a pre-approval inspection, the French supervisory agency found major deviations by an Indian manufacturer of sterile medicinal products. Find out more details about the EMA's non-compliance report here.

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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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