GMP News - Quality Assurance

03.08.22

Ethanol - an important Active Ingredient for Infection Prevention?

WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.

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27.07.22

FDA issues revised draft Guidances for Track and Trace

The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.

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27.07.22

FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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20.07.22

FDA Warning Letters for CBD Products used in Farm Animals

The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.

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13.07.22

The Whistleblower Directive: State of Implementation

In the EU, the so-called EU Whistleblowing Directive was launched in 2019. However, implementation in the Member States is not entirely uniform.

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13.07.22

Serialization - Version 20 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?

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13.07.22

GMP vs GACP: BfArM Makes some Clarifications

The German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.

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06.07.22

EMA Annual Report published

The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.

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06.07.22

Drug Shortages: EMA asks Companies to register a Single Point of Contact

Marketing authorisation holders should register a central contact point to inform the EMA about the availability of certain critical medicines.

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06.07.22

EDQM: List of Reference Standards Updated

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.

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30.06.22

Benefit-Risk Assessment for Product Quality Evaluation

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

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29.06.22

MHRA (UK) now also a full ICH Member

The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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21.06.22

Draft on Labeling Requirements for IMPs Published

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

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15.06.22

EFPIA Member Survey on Current Inspection Trends

The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.

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15.06.22

GMP Deficiencies in the Sterile Area

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.

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