The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of sterile products. Leading industry companies and experts provided a range of insights that included ways to drive and achieve manufacturing and quality digitization strategies, to use advanced and interconnected process modeling to drive new manufacturing-to-clinical trial value and speed to market, to achieve real-time manufacturing release strategies, and to use robotics, cloud technologies and AI to solve industry challenges in areas of contamination control, environmental monitoring, visual inspection and advanced data analysis. Finally, the themes of data quality, integrity and governance resonated consistently throughout the presentations and conversation.
Annex 1 was also integrated into the conference as a timely and complimenting theme. Both representatives from international regulatory authorities and industry specialists helped attendees to more clearly interpret the new regulation and prepare for its adoption in August 2023. Regulators also emphasized the importance of automation and digitization in achieving efficient and sustainable compliance. Notably, regulatory bodies described how they see technology as an essential element of a robust contamination control strategy, such as with the use of advanced environmental monitoring techniques and robotics to help distance people from the product. Agency speakers even hinted at 2023 plans to emphasize this focus on technology, hinting at “listen and learn” sessions with industry and the formation of a Pharma 4.0 / Annex 1 technology working group.
The intertwining of topics at the conference clearly highlighted the concept that a sustainable contamination control strategy will require technology and digitization, and a successful digitization journey will require that companies adopt strong technology-driven manufacturing and quality strategies which must be underpinned by multi-dimensional adoption programs that focus on people, processes, systems, and culture. Key challenges facing the industry include redefining how to maintain compliance and quality amidst an explosion in digital information, the adoption of new data technologies such as artificial intelligence and blockchain, the expanding quantities of digital data and external partners in the supply chain, the increasing speed of new product introductions, and the rapidly evolving expectations to have a holistic governance program to manage data integrity risk and build data integrity by design.
To achieve Annex 1 compliance by the August 2023 deadline, it will be essential for companies to act now by first understanding their current level of compliance and maturity and then by developing phased and tailored programs of improvement. Success will depend upon a trifecta of strongly interlinked strategies for manufacturing and quality digitization, data integrity/governance, and contamination control.
If your company has questions or needs support around preparation for meeting Annex 1 requirements, Lachman Consultants can help! Please reach out to us at LCS@LachmanConsultants.com for a consultation. Time is running out to implement these requirements!
