task force on the revision of Annex 1 Archives - European Industrial Pharmacists Group (EIPG)

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EMA, new features for the PRIority Medicines (PRIME) scheme


By Giuliana Miglierini Based on the review of results obtained in the first five years of implementation of the PRIority Medicines (PRIME) scheme, the European Medicines Agency has launched a set of new features to further enhance the support to Read more

The proposals of the EU Commission for the revision of the IP legislation


By Giuliana Miglierini In parallel to the new pharmaceutical legislation, on 27 April 2023 the EU Commission issued the proposal for the new framework protecting intellectual property (IP). The reform package impacts on the pharmaceutical industry, as it contains proposals Read more

Webinar: Pharmacovigilance as a specialization and the role of the Pharmacovigilance Risk Assessment Committee (PRAC)


EIPG webinar Next EIPG webinar is to be held on Wednesday 31st of May 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Sofia Trantza, a pharmacist with long experience as a Qualified Person for Pharmacovigilance Read more

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Webinar: Implementation of Contamination Control Strategy Using the ECA template

September 28, 2022 , , , , , , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second presentation on the CCS, given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulate contamination.

The presentation explains the implementation of a CCS across a facility and deep dive into the ECA guideline on CCS. An example of CCS implemented by various manufacturers and the ECA CCS template will be presented. This will be followed by a discussion around the future challenges manufacturers may face with the principle of a holistic approach and how novel technology and data science combined with statistics may help in overcoming the future challenges.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

  • European Compliance Academy

 


Webinar: Contamination Control Strategy, an Implementation Roadmap

September 7, 2022 , , , , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 23rd September 2022 (16.00 CEST), on the implementation roadmap of Contamination Control Strategy (CCS). This presentation is given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality (EU Annex 2, EU Annex 14, USP1115, USP1116, FDA aseptic guideline, ICH Q10, Q11). The draft Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulates contamination.

The presentation explains the implementation of a CCS across a facility. It proposes an implementation roadmap to formulate and deploy a successful CCS. Also, it discusses the processes and environments that must be scanned to formulate a CCS. Then, the presentation proposes a method to make the strategy work as intended by implementing the correct control strategies. Finally, it discusses how a company can assess its CCS level over time and improve it.  During the presentation, an online survey will be launched to assess CCS implementation practices amongst the attendees.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.