GMP News - Quality Assurance

24.08.22

FDA publishes ICH Q9 Draft Document

Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.  

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17.08.22

Data Integrity Problems as Main Topic of an FDA Warning Letter

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

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17.08.22

Training and the FDA

The US American CGMP Rules 21 CFR 211 also contain requirements concerning training (21 CFR 211.25). An actual warning letter shows the current interpretation of this requirement by the FDA. How does the FDA interpret the chapter "Training" today?

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16.08.22

FDA offers "Snapshot" Feature for Clinical and Development Guidelines

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

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10.08.22

New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures

Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.

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10.08.22

New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

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03.08.22

FDA expands Remote Regulatory Assessments

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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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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