The European Union Has Announced the Finalized EU GMP Annex 1

The European Union has announced the finalized EU GMP Annex 1 for manufacturing sterile medicinal products. It is creating some reservations for manufacturers who are not certain how these changes may impact their total manufacturing operation and output. In particular, as the August 2023 deadline approaches manufacturers will need to take time to unpack the changes and understand how they will impact their standard operating procedures.

Jennifer Parker, Director of Marketing at Benchmark Products, is advising manufacturers not to wait to consider these new policies. She anticipates the evaluation of SOPs against the guidelines in Annex 1 will require manufacturers to revise and overhaul processes, as well as implement entirely new processes.

Jennifer’s Thoughts:

Although drafts of the new Annex 1 regulations that govern the manufacturers of sterile medicinal products have been circulating for some years now, it still presents a number of challenges when it was actually released in August of this year. Companies will have some barriers when it comes to clients which they will need to meet by the deadline of August next year.

The first one is understanding the complexity of the Annex 1 regulations, being a 50-page document and affecting almost all the areas of production, it will take some time to read, understand, and then evaluate against your own SOPs. And then that’s where I think the biggest challenge is, around evaluating those SOPs against the guidelines. Will you need to rewrite entire operating procedures? Do you need to add new ones where there weren’t any before? And then finally, how are you going to validate your new SOPs? What criteria will you use and the types of products and procedures that you have in place already, will they be sufficient enough to meet the validation criteria?

These are all complex decisions that companies need to make within the deadline. So I really urge manufacturers that are undergoing this process to start early, form a team, and really understand how much work will be involved to get more manufacturing facilities up to compliance.

Follow us on social media for the latest updates in B2B!

Image

Latest

Construction of the HPC Data Center is Prime Destination for AI Progression
May 17, 2024

As digital infrastructure continues to evolve, the strategic development of data centers is crucial. A recent update from Applied Digital celebrates the progress of the company’s HPC Data Center in Ellendale, North Dakota, positioning it as a pivotal player in the advancement of AI technologies. Highlighted in this special video is the HPC Data…

Read More
Nick Phillips of Applied Digital talks community engagement
Community Engagement is Key for Companies Aiming to Support and Impact Local Communities
May 17, 2024

Corporate responsibility is under the microscope but Applied Digital readily stands out for its positive impact on local communities. As part of the broader discussion on community engagement and economic development, there are several things companies can do to contribute to local prosperity. For a special episode for Applied Digital, Nick Phillips, EVP of…

Read More
Ellendale HPC Datacenter
Ellendale HPC Datacenter
May 17, 2024

The shell of our groundbreaking Ellendale HPC Datacenter is nearly complete! With each panel and beam, we’re closer to launching a hub with unmatched AI capabilities, designed for high-density computing. Watch as we shape the future of AI infrastructure

Read More
Sunstone Partners’ 2024 planning and strategy
Sunstone Partners Offsite 2024
May 17, 2024

Sunstone Partners’ 2024 planning and strategy meeting was held offsite in Calistoga, CA this year.  During the event the team bonded in fun activities like wine making and fantastic meals.  On the business side, there was reflection on the significant accomplishments of the team for the year, as well as focusing on upcoming goals…

Read More