GMP News - Aseptic / Microbiology

01.09.21

FDA Warning Letter due to contaminated Hand Disinfectants

As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the USA receives a Warning Letter from the FDA.

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25.08.21

FDA: Warnings about Side Effects and Contamination with Hand Disinfectants

The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.

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25.08.21

Dealing with Particulate Findings in 100% Visual Inspection

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

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21.07.21

The End for the Rabbit Test - only Alternative Methods in 5 Years

Following its 170th meeting the Commission of the European Pharmacopoeia announced that after a defined transition period the pyrogen rabbit test will be completely replaced.

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02.06.21

New USP Chapter on Visual Inspection of Parenterals?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

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11.03.21

COVID-19 Vaccines, Tests and Therapeutics - Recommendations for Handling Emerging Virus Variants

The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.

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24.02.21

FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

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23.02.21

Can the Water Activity Test replace Microbial Testing?

According to the USP no microbiological testing of low water activity pharmaceutical products may be needed after a comprehensive risk assessment. The USP therefore revised the general chapter <1112> Role of Water Activity in Microbial Risk Assessment of Nonsterile Pharmaceutical Products.

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23.02.21

25 Years Alternative Pyrogen Testing: Where do we stand? A Retrospect and Outlook

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

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10.02.21

FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

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09.12.20

Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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04.11.20

Warning Letter regarding Deficiencies in Aseptic Production - Part 2: Media Fill

Deficiencies in aseptic production have led to a Warning Letter to the Japanese company Takeda Pharmaceutical Company Limited. Part 2 of the News deals with deficiencies in the media fill.  What sort of issues did lead to this Warning Letter?

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14.09.20

Warning Letter about Deficits in Aseptic Manufacturing - Part 1: Cleanroom Behaviour and Materials in the Aseptic Area

Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production.  What were the reasons for this Warning Letter?

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09.09.20

Microbiological Environmental Monitoring at the Focus of an FDA Warning Letter

Deficiencies in microbiological environmental monitoring have led to a Warning Letter for the Korean company Samchundang Pharm Co. What deficiencies were found at the inspected company and what measures were required to remedy them?

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26.08.20

Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.

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