Analytical Quality Control News

Analytical Quality Group Developments January through April 2025

Find out what the ECA Analytical Quality Control Group was working on and accomplished in the first four months of 2025 - in the latest report.

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FDA Warning Letter: "Memory-Based Manufacturing" and Lack of Analytical Testing

A recent FDA Warning Letter reveals severe GMP breaches at a U.S. drug manufacturer, including the absence of written procedures, reliance on undocumented processes, and a failure to perform basic analytical testing such as identity, strength, and microbiological checks prior to product release.

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USP: Comments possible on the Topic "Process Analytical Technology"

The new general chapter "<1037> Process Analytical Technology-Theory and Practice" and the two related stimuli articles "Process Analytical Technology I-Theory of Sampling in PAT" and "Process Analytical Technology II-Implementation of Real-Time Release Testing" of the USP have been published on the website of the Pharmacopeial Forum for comments.

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FDA Warning Letter Highlights Analytical Deficiencies: Lack of Release Testing and Unsupported Expiry Dates

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) criticizes major analytical GMP violations observed during an inspection at a Chinese drug manufacturing facility. These include a lack of release testing and unsupported expiry dates for products intended for the U.S. market.

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EMA/CMDh: Nitrosamine Q&A Document updated

The 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", which was prepared jointly by the EMA and the CMDh, has been updated once again and published in the new revision 22 on the EMA website.

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USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>

Revisions to USP Chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Nuclear Magnetic Resonance Spectroscopy—Theory and Practice were proposed for comment in PF 49(5) and are scheduled to become official on 1 December 2025. The USP has now identified other documentary standards that reference these chapters and has published a list of monographs that will be revised accordingly.

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APIC: Update of the Nitrosamine Guide

The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.

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ICH: New Guideline for Stabilities

The draft guideline "STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS" of the ICH was published in April 2025 and is now available for public comment.

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FDA Warning Letter for Chinese Manufacturer: Inadequate Testing and Stability Program Deficiencies

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese OTC manufacturer, highlighting CGMP deficiencies in raw material testing, process controls, stability testing, and quality oversight.

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FDA Warning Letter: Missing Testing for Toxic Impurities and Lack of Stability Data in OTC Drug Products

In a recent Warning Letter, the FDA outlines severe GMP deficiencies in the manufacture of OTC hand sanitizers and antibacterial soaps, including missing identity testing, lack of stability data, and absent process validation. Critical raw materials such as glycerin and ethanol were accepted without proper testing – despite their known risk of contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol, substances that have caused fatal poisoning incidents worldwide.

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