Analytical Quality Control News

Management circumvents Quality Department in Deviation Classification - FDA Warning Letter

In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.

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EC: New Requirements for 'PFAS' Subgroup adopted

In September, the European Commission announced the newly adopted restrictions for 'PFHxA' (undecafluorohexanoic acid), its salts and PFHxA-related substances and published them on its website. The new regulations are reported here in a communication as well as in the Official Journal of the European Union.

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US FDA Warning Letter: Testing of incoming Goods

End of August 2024, the U.S. FDA issued a Warning Letter to the company "Orean Personal Care Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to do proper incoming control tests for identity of their raw materials.

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Host Cell Proteins - FDA seeks Comments on Immunogenicity Assessment

The issue of residues of host cell proteins (HCPs) plays an important role in the manufacture of peptide products. In July, the FDA called for comments via the Federal Register to help assess the immunogenicity risk of such HCPs.

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FDA: Updated Guidance for Nitrosamines

In September 2024, the U.S. FDA published Revision 2 of the document 'Control of Nitrosamine Impurities in Human Drugs' on its website. This 'Guidance for industry' replaces the previous version of 24 February 2021, and was published without a comment period so that comments can still be submitted now.

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USP: Commenting on 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' possible again

The chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' of the USP have been revised again and published on the website of the USP Pharmacopeial Forum for comments. The previous drafts have been discarded. Comments and remarks on these drafts can be submitted until 30 November 2024.

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Meet the AQCG Board Members at PharmaLab 2024

PharmaLab Congress will take place from 25-27 November 2024 in Düsseldorf/Neuss. This year, the program includes a new track on Analytical Instrument Qualification and System Validation, where several Board members of the ECA Analytical Quality Control Group (AQCG) will be part of the speaker team.

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Revision of USP Chapter <1033> on Validation of Biological Assays published

Validation of Bioassays - after a rejected attempt to revise Chapter <1033> at the end of 2022, the USP is now publishing a draft revision based on the currently still official version from 2013.

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Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 2

During the ECA Live Online Training "Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation" on 29 April 2024, many interesting aspects were discussed in the Q&A session. We have compiled a selection of the questions with the teaching team's answers. You can read Part 2 here.

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Bioactivity Testing for ATMPs

Especially for modern pharmaceutical products such as ATMPs, the development and validation of potency assays is characterised by a number of challenges, which are summarised in the following article ‘Bioactivity testing for ATMPs’.

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