GMP News - Quality Assurance

What are FDA's plans concerning new guidelines for calendar year 2019? The Center for Drug Evaluation and Research (CDER) has provided an answer to that question in its list of planned guidelines and/or guidelines to be revised.

The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.

The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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

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?