How to Demonstrate Comparability of Analytical Procedures
A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.
Update of the EMA Q&As on parallel Distribution of Medicinal Products
The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.
EDQM updates List of available Reference Standards
Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.
FDA publishes updated PQ/CMC Document for Comments
In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange document" for comments.
The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?
Manufacturer of "Magic Heal" Receives FDA Warning Letter
In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.
Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.
France is moving forward regarding medical cannabis cultivation and production. As of March 1, it is legal to cultivate cannabis for medical purposes in France.
Due to the introduction of new IT systems, the EDQM has now also adapted the forms for applying for new CEPs, changes to CEPs and so-called "sister files" and plans to implement them on 01 April 2022.
German Pharmacopoeia Drafts for Cannabis Reference Substances
The Expert Committee for Pharmaceutical Biology has recommended drafts for revised cannabis reagent descriptions for inclusion in the German Pharmacopoeia (DAB).
GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits
The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.