GMP News - Aseptic / Microbiology

31.01.24

EMA publishes new questions and answers on Annex 1

At the beginning of 2024, the EMA added 4 new questions and answers to its catalogue of frequently asked questions from the GMP and GDP area.

more

21.11.23

Interpretation of Annex 1 - Swissmedic publishes Q&A Document

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".

more

21.11.23

Severe GMP Violations in the Aseptic Area

Due to numerous and serious GMP violations in the aseptic area, the FDA issued a Warning Letter to an Indian sterile manufacturer in October. The areas affected include media fills, employee behaviour in the aseptic area, cleanroom & equipment design, environmental monitoring and CAPA.

more

02.11.23

Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

more

27.09.23

Changes in Testing for Nitrate and Endotoxins in pharmaceutical Waters in the European Pharmacopoeia

In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).

more

13.09.23

Serious GMP Violations in the Aseptic Area

The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.

more

03.05.23

GMP for Cosmetic Products

The U.S. Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP). Now the agency announced a virtual public meeting on Good Manufacturing Practices (GMP) for Cosmetic Products to be held in June this year.

more

26.04.23

Which Test Sets are used in the 100% Visual Inspection?

In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.

more

16.02.23

Transmission of Malaria by Blood Donors - FDA updates Guidance Document

As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.

more

16.02.23

FDA Information on bacterial Contamination of Platelets for Transfusion

After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.

more

16.02.23

Pyrogenicity Testing - European Pharmacopoeia continues to be updated

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

more

15.02.23

Warning Letter and Recall of a homeopathic Medicine for Children

FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

more

15.02.23

Deficiencies at Sterile Manufacturer

In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.

more

15.02.23

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

more

08.02.23

Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in the new EU GMP Annex 1

PUPSIT is THE most discussed new requirement in new EU GMP Annex 1. But what is the legal basis and what is required? Read more in our GMP News.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics