At the webinar that will take place on 19th June within the framework of Farmaforum 2020 the focus will be placed on regulation. Under the title ‘New draft of EU GMP Annex 1: changes adopted in the latest version and steps towards its implementation’, this regulation that sets the good manufacturing practices on sterile medicines production will be analysed.
EU GMP Annex I is currently under formal revision. After the draft published in December 2017, in which substantial changes were already included, a new version including new adapted text was published last February. The new text has been realigned taking into account many comments provided by experts, in some cases lowering requirements while in some others suggesting higher demanding level, as well as others offering some insights for further clarification.
Changes have been made preserving the substantial philosophy: the need to increase safety in the whole manufacturing process while avoiding the presence of personnel as much as possible in areas where the product is exposed, as well as applying in depth a philosophy of risk analysis and incorporating new technologies. A period of time is currently open for collecting comments before publishing the final version.
Therefore, this webinar will not only review the new requirements detailed in the new version of EU GMP Annex 1, but also debate the appropriate strategy for implementation.
The session will be given and directed by Rafael Beaus, Global Consultancy Manager of Azbil Telstar.
Farmaforum webinars are designed with the aim of continuing to serve as a meeting point for the pharmaceutical sector despite the social distance imposed by the COVID-19 pandemic. A total of 5 webinars, lasting 45 minutes each, will take place throughout the month of June. Experts will analyze and explain the main issues that most concern the sector at this time.
- Date: 19 June 2020
- Duration : 45 minutes