Analytical Quality Control News

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The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation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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FDA Inspections in the EU: Warning Letter to Italian OTC Drug Manufacturer

The U.S. Food and Drug Administration (FDA) continues to conduct inspections within the European Union (EU), as highlighted by a recent Warning Letter issued to an Italian pharmaceutical manufacturer. Following the regulatory findings, the company announced a suspension of OTC production for the remainder of 2024.

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The Interplay of Data Governance, Integrity, and Quality in Pharmaceutical Analysis

Pharmaceutical Technology’s recent publication, authored by Chris Burgess, Chairman of the ECA Analytical Quality Control Group, takes a closer look at the relationships between data governance, integrity, and quality in the context of pharmaceutical analysis. The article aims to provide a structured model for these terms, including their definitions and interrelationships.

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New GMP Journal Article on Analytical Instrument Qualification and System Validation

On the GMP Journal website you can find both all single articles issued in the GMP Journals so far as well as the complete issues - freely available to everybody interested. The new issue includes several articles, including one about the ECA Analytical Quality Control Group's new guide on Analytical Instrument Qualification and System Validation.

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