GMP News

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.

Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.

The GMP regulations do not provide any concrete specifications for the calibration of weighing instruments. They refer to suitable measuring and weighing ranges and the required accuracy. Regular maintenance and calibration are also required.  So how can these general formulations be interpreted?

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.

In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This seems to go on in 2019.

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.

In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?