Tracks & Sessions overview
TRACK 1:
QMS
Quality Risk revision & Why
by Mr. Maurice Parlance, New Wayz Consulting Ltd/CBE Pty Ltd
The ICH has released ICH Q9 revision1: Quality Risk Management. This updated guideline aims to enhance risk assessment practices and decision-making in the pharmaceutical industry. This presentation will discuss the revised Q9 Guidance, specifically focusing on the changes introduced in the updated version. Key areas for improvement i.e. subjectivity, supply & product availability risks, formality, risk-based decision making, hazard identification and risk review will be addressed.
Quality 4.0
by Ms. Shan Shan Liu, No Deviation
How can the industry leverage advanced technologies to enhance quality maturity? This presentation will discuss and explore with the audience the opportunities and challenges of Quality 4.0, regulatory requirements & expectations, and practical examples.
TRACK 2:
Facilities
ASME BPE for Pharma Equipment & Accessories
by Dr. Chatcharit Kiattisaksri, Dockweiler Asia Co., Ltd
This presentation explores the critical importance of ASME BPE certified piping systems for various bioprocessing applications, including pharmaceutical water, biopharma, and chemical pharma industries. The discussion highlights the role of ASME BPE standards and bodies in enhancing the level of hygiene within the process, ensuring compliance with stringent regulatory requirements for safety and performance.
Key sanitary accessories integral to these systems are highlighted, emphasizing their role in maintaining hygiene and operational efficiency. The presentation also delves into the passivation process, showcasing the methods and chemicals used to enhance the passive layer on stainless steel surfaces, thereby improving corrosion resistance and longevity.
The selection of materials according to ASME BPE standards is crucial for ensuring durability and compatibility with bioprocessing applications. Additionally, the influence of surface finish on corrosion resistance is examined, demonstrating how different treatments can significantly impact the longevity and cleanliness of the system.
Furthermore, the processes of roughing and derouging are explained, detailing their importance in preparing and maintaining piping systems. Roughing involves the initial treatment of surfaces to achieve the desired finish, while derouging focuses on the removal of iron oxide layers that form over time, ensuring the integrity and cleanliness of the system.
This comprehensive overview provides a deeper understanding of the technical specifications, processes, and benefits of ASME BPE certified piping systems, reinforcing their essential role in high-purity bioprocessing applications.
Biopharmaceutical Manufacturing Facilities
by Mr. Praphon Angtrakul, Thai FDA
Biopharmaceutical products are the sterile products with aseptic technique processing. Moreover, some of them involve in microorganisms for specific bioprocess for producing targeted products. Care must be taken in designing biopharmaceutical manufacturing facilities. Not only in achieving the sterile products but also the biosafety for personnel and environment must be put into the overall risk assessment.
TRACK
3,6 & 9:
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ISPE TRAINING COURSE
(2 DAYS VIDEO RECORDED)
Pharmaceutical Waters (T32)
This training course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the Water and Steam Systems Baseline® Guide (3rd Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered.
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The course will include discussion of the upcoming European Pharmacopoeia regulatory change allowing alternative WFI production methods in addition to distillation. The change will align EP requirements closely with USP WFI production methods opening opportunities for membrane-based systems. The course will also include material from the new ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam and Process Gases and will review optimizing sampling plans to significantly reduce operational costs.
TRACK 4:
ATMPS
Annex 1 Implication to ATMPs
by Mr. Richard Chai, Steris
ATMPs are medicines for human use that are based on genes, tissues or cells with an active therapeutic substance. With the recent update of the annex 1, it is essential to understand the important considerations from annex 1 perspective on contamination control in ATMP facilities.
The following topics are discussed in detail for this presentation:
- Annex 1 implications to ATMPs – Important considerations
- Best practices in contamination control for ATMP facilities
At the end of the presentation, the participants will have a better understanding on the important considerations from annex 1 perspective on ATMP facilities, and the best practices to minimize risk of microbial contamination.
Comparison among Open/Closed/ Automated Manufacturing Processes of ATMPs
by Ms. Shan Shan Liu, No Deviation
Despite the global rise of ATMP products, they remain in their infancy. For ATMPs, "process defines product" is particularly true. Establishing a commercial manufacturing process that is comparable to the process in development phase, meets GMP requirements, and fulfils market demand is challenging. This session will explore these challenges and the benefits of available solutions.
The ATMPs Industry in Thailand: Opportunities and Possibilities
by Prof. Dr. Sansanee Chaiyaroj, Chairperson, Health and Medicine Program Board, PMUC
ATMPs Industry is very booming in Thailand and other parts of the world because these products are the new hope of therapy. As a result, Thai government offers various kinds of support from drug discovery to commercial manufacturing to create the ATMP Ecosystem. In this regard, Dr. Sansanee Chaiyaroj, Chairperson, Health and Medicine Program BoardProgram Management Unit for Competitiveness (PMUC) will deliver the government support program to enhance the ATMP drug development in the country.
TRACK 5:
QBD/PAT
OSD Continuous Process
by Dr. Narueporn Sutanthavibul, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Continuous manufacturing processes for oral solid dosage forms have gained popularity in the pharmaceutical industry due to their potential benefits in terms of efficiency, flexibility, and quality control.
Throughout the entire process, in-line monitoring and control systems are utilized to ensure the quality and consistency of the product. Continuous manufacturing offers advantages such as reduced production time, decreased waste, enhanced quality control, and increased flexibility in production scheduling. However, implementing continuous manufacturing requires careful consideration of equipment design, process parameters, and regulatory requirements.
PAT for OSD Manufacturing
by Dr. Satoshi Kodama, Powrex Corporation, Research & Development Division
PAT (Process Analytical Technology) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality (definition from ICH Q8(R2)). The overall aim for applying PAT to OSD manufacturing is to ensure consistently high-quality products through better process understanding and continuous improvement. To apply the PAT tool for pharmaceutical manufacturing, there is a need to optimize the hardware so that the PAT monitoring will be possible, along with preparing a suitable software to control the process.
In this presentation, explanation of the originally developed PAT tool (Compact BeatSensor PNIR) and its case studies to various OSD manufacturing process will be introduced. The examples of OSD manufacturing process will include applications to continuous manufacturing system. Also as the latest example, MSPC (Multivariate Statistical Process Control) and MSPC Process Monitoring System “P-i2” including its case study will be introduced.
TRACK 7:
BIO-SAFETY/ CONTAINMENT
Bio-Safety in Laboratory / Production Facilities
by Mr. Dan Yoong, BLS-3 International Certifier
This presentation will explore the crucial topics of biosafety in laboratories and production facilities. The session will begin with an overview of biosafety, outlining its importance in preventing unintentional exposure to and release of hazardous biological agents. We will cover the fundamental principles of biosafety, including risk assessment, containment strategies, and the implementation of standard operating procedures.
As the biosafety levels (BSL-1 to BSL-4) increase, the architectural and engineering requirements become increasingly stringent. Common pitfalls like over-engineering, however, can lead to unnecessary costs for clients. Understanding these principles is crucial to prevent such occurrences. This session will explore the approach to designing a fit-for-purpose facility, especially one that requires bio-containment and GMP concurrently.
An important fit-for-purpose consideration in a biologics facility will be bio-decontamination. Technologies in this field have grown over the past decade. There will be a quick overview of this industrial trend and how facility owners can benefit from it.
Single Pass HVAC for BSL-3
by Mr. Totsapon Santitewagun, ISPE HVAC Qualified Instructor
Single Pass HVAC for BSL-3 plays an important role to achieve biosafety requirement while it consumes a lot of energy compared to the normal HVAC system (Recirculate air). The single pass HVAC is the first choice of consideration to prevent cross contamination in any applications. Key design factor to achieve the performance goals and energy saving will be addressing.
Cleanroom VS Containment
by Mr. Totsapon Santitewagun, ISPE HVAC Qualified Instructor
Cleanroom and Containment are looked similar by appearances. In fact, cleanroom has a big different features and functions from containment. Misuse of cleanroom and containment will lead to the risk of personel, product and environment safety. Cleanroom and containment usages must be clear without any confusion.
TRACK 8:
DIGITAL TRANSFOR-MATION
URS for Computerized System in Pharma
by Ms. Vivien Santillan, Novatek International
The development and implementation of computerized systems in the pharmaceutical industry requires attention to User Requirements Specifications (URS) to ensure the systems are fit for their intended use, support business processes, incorporate business risk assessments, and comply with current regulatory requirements. A well-designed URS is essential for achieving compliance with regulatory standards, enhancing operational efficiency, and maintaining data integrity.
This presentation will outline the critical components and considerations involved in drafting URS for computerized systems, emphasizing the integration of business processes and data workflows with an adoption of the Data Integrity by Design principle to ensure the computerized systems are robust, reliable, and compliant with industry standards.
Digital Solutions for Growth: Transforming Pharma with EBR
by Mr. Orchun Thakral, BatchLine
As the pharmaceutical industry faces increasing demands for efficiency, compliance, and innovation, the adoption of digital solutions has become imperative. This presentation, "Digital Solutions for Growth: Transforming Pharma with EBR," will explore how Electronic Batch Records (EBR) are revolutionizing the way pharmaceutical companies operate, driving growth and enhancing operational excellence.
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This presentation will delve into the following key aspects:
Streamlining Compliance, Quality, Efficiency, and Productivity: Discover how EBR solutions streamline regulatory compliance and improve product quality by automating documentation and real-time monitoring. Learn how these solutions enhance efficiency and productivity by reducing cycle times and optimizing resource utilization.
Gaining Deeper Insights with Electronic Data: Explore how leveraging the electronic data recorded in the EBR platform provides deeper insights into manufacturing processes. See how data-driven decision-making and continuous process improvement are enabled through advanced data analytics.
Integration with IIoT for a Connected Future: Learn about the benefits of integrating EBR solutions with Industrial Internet of Things (IIoT) devices. Discover how this integration creates a connected and intelligent manufacturing environment that enhances visibility and control over production processes.
This presentation is tailored for industry professionals eager to explore the transformative potential of digital solutions in the pharmaceutical sector. Whether you are just beginning your digital journey or seeking to enhance existing systems, this presentation will provide valuable insights and practical strategies to leverage EBR for growth and success.
Digitalising Pharma Facilities with Composable Tools
by Mr. Shaokai Hong, Tulip
This presentation will exemplify the use of the inherent capabilities of new digital technologies in support of Pharma 4.0. The latest experiences with digital tools used for batch recording and digitisation of GMP processes and procedures have shown significantly less effort spent on achieving compliance and decreasing the cost of quality. Digital solutions provide easily accessible and interpretable documentation stored digitally with compliance built-in and are not an afterthought. Our industry is experiencing a true paradigm shift and we need to embrace change to capitalise on the promise of Pharma 4.0.
Facility & Laboratory Concept & Design for Digital Transformation
by Dr. Nizamil Fairuz, PharmEng Technology
Conventional mindset towards designing new facility and laboratory is commonly towards its purposes and functionality. Facility provides controlled conditions, such as clean environment room with specific temperature, relative humidity, and level of cleanliness, and lab provides analytical testing and results for quality decision.
Digital transformation in Pharma Industry 4.0 is currently the bridging process that leverages digital technologies to digitalize existing processes, facilitate effective analytics decisions, and improving the competitiveness to align with evolving era of digitalization. Laboratory facility is a tangible aspect of cGMP, as it represents analytical quality attributes, which the current concept & design must support effectively with digitalization.
Facilities with the integration of a data-driven tools like IoT, Automation & Maintenance Systems, Building Management Systems, and Environmental Management Systems can optimize facility maintenance and quality monitoring. It enables a real-time quality monitoring and perform predictive maintenance before any disruptions.
A laboratory with a leap of digitalization concept effectively improved its operations including supply chains, analysis and report, data integrity, personnel, and instruments. The laboratory, therefore, becomes more automated and smarter.
In summary, Facility & Laboratory Concept & Design for Digital Transformation for Pharma Industries, enables a real-time accumulation of quality data from facility & lab, and subsequently perform the data analytics to enhance quality monitoring, quality decision, quality release, as well as streamlining the overall process, and minimizes cost.