Analytical Quality Control News

How to keep Analytical Systems Current and Compliant

In Technology Networks, a new article entitled "The Museum of Analytical Antiquities" was published. The authors, Dr. Bob McDowall, a member of the ECA Analytical Quality Control Group Advisory Board, and Paul Smith, explore the risks and challenges laboratories face when they maintain outdated analytical systems and discuss why it is important to keep current with software updates.

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FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2024

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for fiscal year 2024 (October 2023 – September 2024). As in previous years, we have conducted an evaluation regarding deficiencies in the stability program.

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USP-NF Stimuli Article on Apex Vessels used in Dissolution Testing

In the Pharmacopeial Forum, PF 51(1), a Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities" was published. Apex vessels, previously referred to as PEAK vessels, are commonly used in dissolution experiments with Apparatus 2. The study highlights the importance of understanding the geometric variability of apex vessels and its potential impact on dissolution results.

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Elemental Impurities: Harmonized chapter finalized

In late November 2024, it was reported on the EDQM's website that the new harmonized chapter "Elemental Impurities (G-07)" of the "Pharmacopoeial Discussion Group (PDG)" was signed in June 2024.

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New FDA Guidelines: Batch Uniformity and Drug Product Integrity / Advanced Manufacturing Technologies

The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation Program."

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Data Integrity violations and ineffective Quality systems

Data Integrity violations and ineffective Quality systems caused a Warning Letter of the U..S FDA issued in December 2024, to the US American company "Viatris, Inc." after having inspected its Indian site "Mylan Laboratories Limited, Inc., a Viatris company" in June 2024. 

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EDQM publishes new FAQ on System Suitability Test (SST)

The EDQM has announced the addition of a new FAQ to its existing series, addressing the system suitability test (selectivity) in chromatographic assay procedures. This update comes in response to user inquiries received via the HelpDesk.

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CMDh/EMA: Update of Appendix 1 for Nitrosamines

Appendix 1 to the EMA/CMDh nitrosamine Q&A document 'Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products' was updated in December 2024.

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Another FDA Warning Letter Based on Review of Records

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese OTC manufacturer based on a review of records. As seen in other recent FDA Warning Letters reported in the ECA newsletters, the cited violations include issues with identity testing, specifications, stability testing, and quality unit oversight.

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FDA Warning Letter to South African OTC Drug Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations, identified through a review of records, include insufficient component testing, inadequate quality control, and improper stability testing.

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