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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
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.

More
x