GMP News

In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.

Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.

A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.

In the course of a survey in the GMP/GDP environment, about 200 questionnaires were filled out. The aim of the survey was to record the current status of the implementation of GMP/GDP training measures in the pharmaceutical industry. Read more here about the results of the survey on GMP/GDP training.

The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."

The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product. 

The European Parliament wants the European Union to become more independent with regard to pharmaceuticals and medical devices. A report on this has now been developed and adopted.

The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.

Roughly 10% of deficiencies raised by MHRA inspectors were directly attributable to poor investigations. So what do inspectors observe?

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020). Learn more about the top 3.

The UK Medicines and Healthcare Products Regulatory Agency MHRA has published a guide the marketing of medical devices after the transitional period in the UK.