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Annex 1 Implementation & Pharma 4.0
Wed, 11 Dec
1045 – 1115
Annex 1 Implementation & Pharma 4.0
Ruben Van Der Galiën, GEHealthcare
A Contamination Control Strategy (CCS) is a document which focuses on how to prevent contaminations with microorganisms, particles and pyrogens within a sterile and/or aseptic and preferably also in non-sterile manufacturing facilities. This document determines in what extent measures and controls in place are efficient in preventing contamination. In order to efficiently evaluate and control all potential hazards associated with sources of contamination within a CCS, the Hazard Analysis Critical Control Point (HACCP) methodology could be a useful tool to monitor all Critical Control Points (CCPs) related to various sources of contamination. This article describes a way to set up the CCS within a pharmaceutical sterile and aseptic manufacturing facility (GE HealthCare Pharmaceutical Diagnostics) applying the HACCP methodology. In 2021, a global CCS procedure and a general HACCP template became effective for the GE HealthCare Pharmaceutical Diagnostics sites having sterile and/or aseptic manufacturing processes. This procedure guides the sites through the set-up of the CCS applying the HACCP methodology and helps each site to evaluate whether the CCS is still effective taking all (proactive and retrospective) data following the CCS into account. A summary of setting up a CCS using the HACCP methodology, specifically for the pharmaceutical company GE HealthCare Pharmaceutical Diagnostics Eindhoven site, is provided in this article. Using the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards and/or control measures and CCPs. The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed. All current states are reflected by a traffic light color to reflect the level of residual risk, thereby providing a simple and clear visual representation of the current contamination control and microbial state of the manufacturing site.
1115 – 1145
Annex 1 Implementation & Pharma 4.0
Runa Ulsoe, UCB Pharma
Giuseppe Leonardi, UCB PHARMA S.P.A.
The Updated Annex 1 that went into force in August 2023 has been revised to:
• Reflect changes in regulatory and manufacturing environments and in the advanced technology in contamination control
• Incorporate principles of ICH Q9 Risk Management ICH Q10 Pharmaceutical Quality System and using this when taking advantage of the new possibilities by using innovative tools
• To correct inaccuracies and offer more detail to remove ambiguity
• Align this guideline with international requirements
• Clarify other areas of potential applicability of Annex 1 utilizing QRM principles
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
• Reflect changes in regulatory and manufacturing environments and in the advanced technology in contamination control
• Incorporate principles of ICH Q9 Risk Management ICH Q10 Pharmaceutical Quality System and using this when taking advantage of the new possibilities by using innovative tools
• To correct inaccuracies and offer more detail to remove ambiguity
• Align this guideline with international requirements
• Clarify other areas of potential applicability of Annex 1 utilizing QRM principles
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
1145 – 1215
Annex 1 Implementation & Pharma 4.0
Matthias Kress, BioGrasp GmbH
James Sunna, Theos-CES GmbH
In this presentation, we explore the advanced stage of Pharma 4.0 maturity and the benefits of adopting a fully data-centric architecture. Currently, pharma companies face challenges in meeting information demands within a QbD (Quality by Design) framework due to system boundaries and complex data pathways. A data-centric approach, where data exchange and management are separated from computation and decision-making, can overcome these issues. We demonstrate the effectiveness of this approach through showcasing a QbD use case, focusing on an aseptic filling scenario to align with the conference's Annex 1 focus. The second part of the presentation addresses the requirements for implementing data-centric architectures. It emphasizes the need for a data architecture framework tailored to the pharmaceutical domain and adopting established standards like ISA95 and ISA88. We introduce a preliminary framework developed to align with proposed principles from our concept paper.
1345 – 1415
Annex 1 Implementation & Pharma 4.0
Bill Rusitzky, SRI International
Annex1 requires minimizing human intervention in critical areas such as fill and finish operation. Robot Telemanipulation allows a person to control robot arms from outside the sterile or hazardous environment. On a daily basis Robot Telemanipulation enables Robotic Surgery and bomb disposal. In Pharma manufacturing, today tasks that cannot be efficiently automated, require human intervention, often placing the pharmaceutical product or the operator at additional risk.
The advancement in robotic telemanipulation permits individuals to perform manual interventions without entering sterile or hazardous areas. With stereo 3D vision, operators have a lifelike view of the environment, while telemanipulation software empowers precise control over robotic arms, akin to how surgeons operate with robotic surgery today.
Today Robot telemanipulation is being used by large Pharma companies to test use cases and plan operational rollout, minimizing human interaction with the sterile and hazardous areas.
The telemanipulation systems will also have additional benefits including the ability to record data and the 3D video enabling complete documentation of the interventions.
The advancement in robotic telemanipulation permits individuals to perform manual interventions without entering sterile or hazardous areas. With stereo 3D vision, operators have a lifelike view of the environment, while telemanipulation software empowers precise control over robotic arms, akin to how surgeons operate with robotic surgery today.
Today Robot telemanipulation is being used by large Pharma companies to test use cases and plan operational rollout, minimizing human interaction with the sterile and hazardous areas.
The telemanipulation systems will also have additional benefits including the ability to record data and the 3D video enabling complete documentation of the interventions.
1415 – 1445
Annex 1 Implementation & Pharma 4.0
Christian Scarpato, Merck Serono S.P.A.
Designing an APS that accurately mirrors the complexities of lyophilization is a formidable task. However, adapting certain aspects of the process using scientific rationales and risk-based approach, it is possible to devise an APS plan that closely mimics routine aseptic lyophilization while ensuring the viability and recovery of contaminants.
1445 – 1515
Annex 1 Implementation & Pharma 4.0
Geert Vandenbossche, PhD, C&E Solutions BV
Radio Ligand Therapy (RLT) production has evolved from research to clinical and commercial applications, requiring strict adherence to Annex-1 standards, while still assuring radioprotection of production operators. Basic advancements include separating synthesis, sterile compounding, aseptic filling and crimping. Several activities require unprecedented challenges: visual inspection and labelling of radioactive, individualized vials, but also filter integrity testing, leak testing and environmental monitoring of a radioactive environment in negative pressure requires extra precautions.
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Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.