GMP News - Aseptic / Microbiology

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.

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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.

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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.

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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..

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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.

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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)?

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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.

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11.01.23

Expert Task Force issues new Version of CCS Guideline

With the publication of the final version of the revised Annex 1 in August, the ECA Foundation's CCS Task Force got together again to update the CCS Guide based on the final Annex 1 version. The new CCS Guide version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity and the update of the attachments.

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11.01.23

Cross Contamination in Steam Steriliser at US Sterile Manufacturer

In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.

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02.11.22

Sterile Product Manufacturing Process: Warning Letter to Texas Longhorn

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

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12.10.22

Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 2

Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?

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05.10.22

Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 1

Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?

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28.09.22

PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)

Almost simultaneously with the EU Commission, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) also published the revised Annex 1. What is the background?

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31.08.22

Finalised: The revised EU Annex 1 is published

After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.

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30.08.22

FDA draws consequences for poor quality of hand disinfectants and UV Wands

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

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