GDP Related Regulations Announced at the First Leading Minds Seminar29.May.2015
The first Leading Minds Seminar hosted by ELPRO and Envirotainer took place May 5-6 in New Brunswick, NJ. Chosen for its location in close proximity to pharmaceutical manufacturing hubs. The two days consisted of regulatory plenary sessions, breakout group discussions and User Group meetings. Speakers included the MHRA, United States Pharmacopeia, Lundbeck, Merck, AbbVie, IATA, American Airlines, Novartis, ELPRO and Envirotainer.
A group of about 70 industry professionals, mostly pharma manufacturers, engaged in practical discussions how to overcome ongoing issues such as tighter collaboration between supply chain partners, how to use a stability budget, how to use a central archive of temperature data, reducing excursion processing time and very importantly, what regulations were coming down the chute they need to comply with.
Ian Holloway, from the MHRA gave an excellent presentation that explained how data integrity is becoming more concerning in regulatory audits, especially in some newer markets. 2015 new regulatory expectation is to have minimum one data logger per pallet (not per shipment where there may be 10 pallets for example spread out in hold of aircraft). Also, he said prompt local reading of data logger post shipment is more reliable that can be used as evidence for proper investigation and CAPA. He outlined new and upcoming changes to GDP related guidances, including:
- Revised Chapter 8 EU GMP Guide – Extensive changes to Quality Risk Management principles, Root Cause Analysis and CAPA requirements. Effective 1 March 2015.
- GDP of Active Substances. Go-live 1 September 2015
- Revised EU GMP Guide Annex 15 – Qualification and Validation introduces new section “Verification of Transportation”. Effective 1 October 2015.
- Expected issue of Revised EU GMP Guide Annex 16 - Certification by a Qualified Person and Batch Release. Publication of final version awaited.
- MHRA GMP Data Integrity Definitions and Guidance for Industry. Published March 2015
Mary Foster, United States Pharmacopeia, gave an informative session, asking for the audience’s input to the developing <1083> standards guidance. New sub-chapters in <1083> are being worked on that include Excipients, APIs, Packaging Components & Materials, Clinical Trial Materials. Because the FDA provides input to <1083> development, the industry views USP’s work to define these standards vital to knowing what the regulatory expectations are in the US.
Speaker, Cyril Winkler from ELPRO, explained in his session that three sources of data including shipment, temperature and product must be collected centrally to be able to create meaningful analysis of temperature control shipping processes, lanes and partners. Also, participants were interested to discuss with each other how when launching a global data monitoring system, it’s important to build a common understanding early with the project team to decide what the group wants to collect and what type of reports are needed.
Speaker Lisbeth Nielsen, from Lundbeck showed how they have overcome a number of problems in their clinical supply chain that were slowing down the release process and administering patients. For example, they previously had a lack of visibility at clinical sites after shipment was received. Once they started tracking open shipments in the database, they could see if data logger has been properly uploaded to database, and follow-up with sites about missing reports.
Overall, the seminar and User Group meetings gave participants a lot of opportunity share ideas, experiences and most importantly solutions with each other. One delegate put it well, «I wanted to come to share problems and see other industry colleague’s grass stains. It’s only by discussing the details of problems, will we come to resolving them».
ELPRO and Envirotainer look forward to hosting the next Leading Minds Seminar to keep industry discussions moving forward, always aiming for improving best practices and safe medicines for patients.
If you’d like a copy of the post seminar report, or to be notified when dates are announced, please e-mail usa[at]elpro.com.