ISPE & the ISPE Foundation invite students and recent graduates to join us for a session to get the most out of your experience at ISPE’s Pharma 4.0 & Annex 1 Conference. You’ll gain career advice, learn about the benefits of your ISPE membership, and participate in an interactive activity.
This session is tailored specifically to recipients of the 2023 ISPE Pharma 4.0 and Annex 1 Conference Student and Recent Graduate Attendance Grant.
The new EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” in its final version published on August 25th 2022 requires in paragraph 4.30 “…a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position…” WHO in January 2023 published their Annex 2 “WHO good manufacturing practices for sterile pharmaceutical products“ and provided a different wording: “…a homogeneous air speed in a range of 0.36–0.54 meters per second (m/s) (guidance value) at the working level…“ This raises the question of “Where to provide which air speed and where to measure and monitor the air velocity?” This presentation initiated by the steering committee of ISPE D/A/CH Community of Practice “Aseptic Processing” wants to show with real data the effect on unidirectional airflow pattern and air velocities at point of fill: working position as well as working level. The data were generated based on CFD simulation with a machine model (vial filling/closing machine) in an open double wall isolator environment. Additionally air velocity measurements and airflow visualization studies were performed with the real model – machine (detailed mock-up) inside real isolator.
Companies are seeking to digitize, digitalize, and transform their business processes and organizations. Now more than ever, organizations must seek boundaryless data, information and knowledge flow to ensure their colleagues have the knowledge they need to make timely and informed decisions. Linking with the ICH Q10 enabler of Knowledge Management, this session will holistically: 1)Share the concepts of knowledge management to enable knowledge flow 2)Offer how organizations may think differently about ways of working, new roles, and organizational constructs in a digitalized world to enable information and knowledge flow. Note this will be further discussed in the Fireside chat with Teresa Minero and Heike Roeder in the following talk. 3)Considerations for digitizing and improving processes, within the PQS and the business; how we might capture and harness the ‘know how’ from our people in our processes?
The updated version of Annex 1 further emphasizes validation and qualification in a holistic approach, harmonized with an integrated implementation plan that has its foundation on a partnership between all pharmaceutical departments. Each pharmaceutical process and its respective validation or qualification demonstrate how implementation and adherence to intended purpose need to take into consideration all the product characteristics that have an impact on quality. Minimizing the risk of microbial, particulate, and endotoxin/pyrogen contamination is essential when producing sterile products. These characteristics ought to be studied, controlled, and included in the definition of a control strategy. Several types of sampling tools can be applied to meet these environmental monitoring requirements. Active air sampling is regarded as the most interesting way to collect repeatable samples, possibly with automation, and a single use device could facilitate sample integrity in routine usage. The main driver is always the understanding of the process and a higher predictability of outcomes, which sometimes means faster decision-making paths in case of excursions. A complete qualification is very important for the entire validation process both in terms of accountability and reproducibility from a quality point of view. A deep understanding of your process means that the materials brought in will likely produce a usable and sellable product, limiting the risk of shortages, reducing rejections, and subsequently lowering costs.
After years of digital transformation with focus on investment into new technologies, data, systems the life sciences industry have identified organization development as the challenge. However, the typical change management campaigns like communication, upscaling digital skills, and hiring data scientists are not enough.
Teresa Minero and Heike Roeder both experienced digitalization transformation leader will interactively discuss the following aspects:
- Illustrate the dimension of the transformational journey going through the digital maturity as fundamental new organizational set-up and leadership
- Provide insights of industry feedback together with real life experiences, and their specific challenges
- Envision and share the principles for a successful organizational development as holistic transformation
The quality of the CCS is highly dependent on the resolution of the available risk data - the more accurate this risk data is, the more targeted and effective these control mechanisms can be. The presentation introduces the Frame-by-Frame Risk Profiling approach for generating end-to-end CCS. Frame-by-Frame Risk Profiling identifies trends and recurrent patterns that indicate potential risks to the process. Process-frames have resulted from contextual and operational aspect assessment of the task and the context in which the process occurs. Accumulation of these process-frames have led to data-based frame library that provides a centralized repository of information that can benefit to inform the assessment process consistently and objectively. Every process-frames incorporate high-resolution risk data which can be used to generate end-to-end CCS for ATMPs. By linking to the Process Frame Library, an end-to-end CCS can incorporate targeted risk mitigation strategies for MBR, work instructions, QA monitoring guidelines, and training, and keep all information consistent across processes and manufacturing sites. Furthermore, end-to-end CCS incorporates Pharma 4.0 technologies such as Virtual Reality in order to train and assess operator behavior. The presentation will also share insights from implementation of Frame-by-Frame Risk Profiling Pilot at Johnson & Johnson CAR-T.
Pharmaceutical Product Quality is the outcome of enhanced process understanding combined with decisions made based on process and product data. In this session I will discuss how the pharmaceutical quality can be enhanced by having access to the right data at the right point in time, making it possible to make real time quality decisions. Being able to make such decisions requires an improved Process Performance and Product Quality Monitoring System (PPPQMS) by acknowledging the digital opportunities that we have. In order to express an enhanced process understanding in a Holistic Control Strategy and to be able to make real-time quality decisions, we must have access to real-time process and product data; have systems connected across the manufacturing supply network; and have defined supportive analytical and continual improvement elements. The ISPE APQ PPPQMS guide has been developed to support the industry in establishing a PPPQMS system with its different elements for Quality 4.0. At this session I will provide practical examples of the elements of this system.
At the forefront of progressive enterprises, there is a continuous and concerted effort to foster a culture where the responsibility for quality practices and results is shared across functions. This entails not only the evolution of robust quality practices and competencies but also the serious endeavor to ingrain every function of the organization with a prevalent culture of quality. The overarching objective here is to cultivate a landscape where ownership and active participation in all aspects of operations converge to yield outcomes of the highest quality.
In this presentation, we will discuss the pivotal role of quality culture in shaping quality maturity. Furthermore, we will elaborate on the six sub-elements of ISPE APQ cultural excellence: 1) leadership and vision, 2) mindsets and attitudes, 3) Gemba and employee engagement, 4) leading quality indicators, 5) proactive oversight, and 6) quality enablers and we will elucidate their intricate connections with systems, data, processes, and the organizational framework. Finally, our focus will shift to the implementation of digital strategies that support quality maturity and increases manufacturing efficiency and productivity while nurturing a culture of quality that effectively addresses both compliance requirements and competitive advantage.