Analytical Quality Control News

Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter

An FDA inspection revealed serious CGMP violations related to sampling, testing, and quality oversight at a U.S.-based drug manufacturer, underscoring the critical importance of scientifically sound sampling strategies.

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EMA publishes new Product-Specific Bioequivalence Guidance

The European Medicines Agency (EMA) has added new entries to its “Product-specific bioequivalence guidance” section, publishing updated guidelines for individual products.

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Revision of USP Chapter <1039> Chemometrics Published for Comments

In Pharmacopeial Forum 51(4), the USP has published a major revision of General Chapter <1039> Chemometrics for public comment. The update reflects the rapid evolution of the field, particularly driven by developments in machine learning and AI.

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Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers

In the Pharmacopeial Forum, PF 51(4), a proposal for a new USP General Chapter <318> Nuclear Magnetic Resonance Spectroscopy Monomer Ratio Determination for Lactide–Glycolide Polymers has been published for public comment. Developed by the Excipients Test Methods Expert Committee, the chapter introduces a validated proton NMR method to quantify the monomer ratio in ring-opening copolymers of DL- or L-lactide and glycolide.

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New USP Chapter <1221> on Ongoing Procedure Performance Verification (OPPV) Published for Comment

In Pharmacopeial Forum 51(4), the USP proposes a new General Chapter <1221> Ongoing Procedure Performance Verification. As Stage 3 of the Analytical Procedure Life Cycle (<1220>), the chapter introduces a risk-based approach to ensure consistent method performance during routine use. The draft is open for public comment until 30 September 2025.

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FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls

A recent FDA Warning Letter highlights GMP violations at a U.S. manufacturer of over-the-counter (OTC) drug products, including missing microbiological testing, lack of stability data, and inadequate raw material controls.

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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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