ECA Academy

[ECA Academy @ECAacademy]

The #FDA has issued a #WarningLetter to Glenmark Pharmaceuticals. During an inspection at the site in Goa, India, several GMP violations were found - like failing to thoroughly investigate OOS results. https://t.co/xjniimaDUc

[ECA Academy @ECAacademy]

As a result of the revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" - available on the ICH website, the USP chapter "<232> Elemental Impurities-Limits" has now been revised and published for comments on the USP Pharmacopeial Forum website. https://t.co/2yJf8Zc0L7

[ECA Academy @ECAacademy]

The Danish Medicines Agency has revised its guidelines on the requirements and expectations of the QP. In places, these deviate from the requirements of Directive 2001/83/EC, especially with regard to education and experience. https://t.co/SGGTVWpKnY

[ECA Academy @ECAacademy]

In November 2022, the U.S. #FDA issued a #WarningLetter to the U.S. American company Kari Gran Inc. after having inspected its site in July 2022. The Warning Letter mentions the list of #cGMP observations for finished products. https://t.co/XmFE4ZXejn

[ECA Academy @ECAacademy]

The ECA regularly provides evaluations of the #FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. https://t.co/VQmjaqPXqk

[ECA Academy @ECAacademy]

Observations during #FDA inspections are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. https://t.co/0zIICmf6MZ

[ECA Academy @ECAacademy]

There has been a recent accumulation of #WarningLetter from the #FDA to manufactures of hand sanitizer products. In a new case, FDA laboratory analyses showed, among others, that the ethanol content of several batches was too low. https://t.co/B0L9dkch2s

[ECA Academy @ECAacademy]

Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised? https://t.co/7WBADRLBYY

[ECA Academy @ECAacademy]

In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. https://t.co/YxVtD33m73

[ECA Academy @ECAacademy]

The U.S. #FDA warns five companies for illegally selling food and beverage products containing cannabidiol (#CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use. https://t.co/w3wMKpoeMy

[ECA Academy @ECAacademy]

Some authorities within the PIC/S (#pics) want to mutually recognise #GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this. https://t.co/FXy4xW3kqg

[ECA Academy @ECAacademy]

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (#CTR) for the labelling of investigational medicinal products (#IMP) regarding expiry dates by means of a Delegated Regulation. https://t.co/8g76FMvj3P

[ECA Academy @ECAacademy]

An increasing number of companies with no previous #GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical #cannabis products. Thus, the #MHRA recently posted how the required licences are granted by the agency. https://t.co/PbsKXu1BIA

[ECA Academy @ECAacademy]

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another #WarningLetter has been published by the #FDA, also addressed to such products. https://t.co/pC4UjPUvqE

[ECA Academy @ECAacademy]

The analysis of the #WarningLetters sent out in fiscal year 2022 offers a revealing overview of what #FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" #GMP violations. https://t.co/mt31WScC4J

[ECA Academy @ECAacademy]

In a #WarningLetter to a US manufacturer, the #FDA criticises investigations after deviations in the media fill. Also, derived #CAPA measures did not go far enough for the FDA. https://t.co/7ScgcXjoIv

[ECA Academy @ECAacademy]

In a blog post, the UK #MHRA comments on the resumption of international #GMP inspections and the validity of expired GMP certificates. https://t.co/JX5FgAX5m8

[ECA Academy @ECAacademy]

The latest version (version 16) of the "How to do" document - Interpretation of #ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new #APIC website at the end of October. https://t.co/kw3mdErhG3

[ECA Academy @ECAacademy]

The #FDA has issued a #WarningLetter to a U.S. manufacturer - highlighting the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. https://t.co/Run8WtIzgC

[ECA Academy @ECAacademy]

The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". This document presents the most important results of the analysis of the security of supply and possible measures. https://t.co/NCZ8S2vRyq