GMP News

During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.