In the Pharmacopoeial Forum PF 51(4), the USP has published the draft revision of chapter <1231> "Water for Pharmaceutical Purposes". See the proposed changes to the general water chapter.
Following the revised draft chapter issued last year, the USP Herbal Medicines Compendium (HMC) published the Final Authorized Version 1.0 of its Cannabis Species Inflorescence Monograph.
A new Ph. Eur. chapter 2.5.46. Phenolic antioxidants in plastic materials has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.
The draft of the updated guideline of the ICH entitled 'THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY M4Q(R2)' was published in May 2025 and is now available for public comment.
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.
The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", containing some interesting results that not everyone may have expected.
Malta's Medicines Authority recently issued two GMP non-compliance statements: One to a manufacturer of cannabis-based medicinal products and another to a Quality Control testing laboratory for the analytical testing of non-sterile dosage forms (specifically for medical Cannabis products).
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.
Find out what the European QP Association was working on and accomplished in the first four months of 2025 - in the latest report.
Find out what the ECA ATMP Group was working on and accomplished in the first four months of 2025 - in the latest report.