GMP NEWS 2019

In January 2019, the US American FDA issued a Warning Letter to a manufacturer from India. Among other things, the pharmaceutical water system was criticized. Read more here.

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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 US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

The revised Swiss HMG came into force on 1 January 2019 - with some interesting GMP/GDP-relevant changes.