GMP News

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.

FDA inspectors usually expect a minimum level of GMP understanding for identity and assay determinations of starting materials and finished products. Read here which basic GMP deficiencies in the quality control laboratory have led to a Warning Letter regarding incoming goods controls and testing of finished products.

The EDQM has published four updated Public Documents on the revision, renewal or re-application of a CEP. Here you can find out what has to be considered when describing an API and its quality in a CEP application.

At the beginning of the year, the EDQM published a revised version of its guidelines for the preparation of monographs on radiopharmaceutical preparations. It now includes a new section on method validation.

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.