Dr. Christopher Burgess, Chairman of the ECA Analytical Quality Control Group (AQCG), will present a webinar titled Enhancement of General Chapter Analytical Instruments and Systems Qualification; a Full Lifecycle Approach, organized by USP Education.
In the current Pharmacopeial Forum, PF 51(3), the USP has published a revised draft of General Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples. The deadline for submitting comments is 31 July 2025.
The ECA Analytical Quality Control Group (AQCG) has published a new guidance document on Sampling and Sample Management. The PDF file is available for free in the AQCG members area. Additionally, a free webinar for all members is scheduled for 17 June 2025.
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.
A draft reflection paper on patient access to electronic product information (ePI) is available for public consultation. In addition, the EMA ePI team is looking for testers able to create FHIR XML ePI files compliant with the EU ePI Common Standard.
The use of real-world data (RWD) in the development, approval and monitoring of medicinal products continues to increase. Last year, the EMA published a draft Reflection Paper On use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes. Now, the final version of the Reflection Paper was published on the EMA's RWE page.
The European Medicines Agency (EMA) has launched a public consultation on a potential Key Information Section in the Package Leaflet (PL) of centrally authorized medicinal products. The EMA would like to invite all interested stakeholders to respond by 31 May 2025.
On May 8, 2025, the European Medicines Agency (EMA) released a concept paper proposing revisions to Part IV of the EU Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). This initiative aims to align ATMP-specific GMP requirements with recent updates in sterile manufacturing and to incorporate advancements in technology and quality management systems.
The United States Pharmacopeia (USP) is considering a revision to its definition of controlled room temperature (CRT), aligning it with the ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). A Stimuli article published in the current Pharmacopeial Forum, PF 51(3), highlights that the existing discrepancy between USPs CRT definition (2025C) and the JP, EP, and WHO standards (1525C) leads to inconsistencies in drug storage practices and increased energy consumption.
Back in October/November 2024, the FDA carried out an inspection at a US manufacturer of OTC products and uncovered a number of GMP deficiencies, including in process validation, which has now led to a warning letter. Continue reading.