The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.
The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.
The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.
The USP revised the general chapter <661.1> Plastic Materials of Construction. In particular the sections on Polycarbonate and PVC have been updated.
In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.
There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.
The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.
The Chemical Analysis Expert Committee intends to revise the USP General Chapter <621> Chromatography. Changes to the subsection on the signal-to-noise ratio are planned.
In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.
The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.