March 31st is the deadline for the completing your step 1 risk evaluation on potential nitrosamine impurities in medical products. These highly toxic compounds, some of which are considered to be even more carcinogenic than currently established thresholds, are...
Join us for part 2 of our webinar series on pharmaceutical manufacturing construction materials on Wednesday 3 February 2021 from 14:00 – 15:30 In this seminar, we will discuss how to address particulate matter findings in pharma production facilities. Programme:...
Are your production equipment and systems qualified for product contact? On Wednesday 13 January 2021 from 15:00 – 16:30, we will be hosting a webinar on the role and design of extraction studies to ensure safety and quality in pharmaceutical manufacture. Programme:...
As of today, 5 January 2021, all suppliers of physical products in the EU market are required to track and report the content of substances of very high concern (SVHC). This information shall be made available to consumers and waste operators by filling in the...
Do you manufacture an in vitro diagnostic medical device? If so, you will need a CE Mark certificate to market it in the EU. A CE certificate verifies that a product is safe and performs as intended. The regulation, (EU) 2017/746 (IVDR) Annex I, prescribes general...
In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas...
