This is a past event. Registration is closed. View other Parenteral Drug Association - Asia Pacific office events.
Registration
Keynote Address
Dr. Shanti Marlina Sibuea, S.Si., Apt., M.Sc.
  • Dr. Shanti Marlina Sibuea, S.Si., Apt., M.Sc. (Ketua Tim, Pengawasan Produksi Produk Biologi Direktorat Pegawasan Produksi ONPP at Badan POM)

    Dr. Shanti Marlina Sibuea, S.Si., Apt., M.Sc.

    Ketua Tim, Pengawasan Produksi Produk Biologi Direktorat Pegawasan Produksi ONPP at Badan POM
Welcome and Workshop Introduction
Coffee Break
Annex 1 Technical Interpretation: how to implement Annex 1
Hue Kwon

Since EU and PIC/S Annex 1 became effective on August 25, 2023, sterile product manufacturers are implementing necessary changes and/or actions to be compliant with new or updated Annex 1 requirements. This session will help the companies how to interpret Annex 1 requirements to ensure appropriate implementation of necessary actions.

  • Hue Kwon (Member, RAQAB at Parenteral Drug Association)

    Hue Kwon

    Member, RAQAB at Parenteral Drug Association
Product Demo by Merck: Single Use Assembly as Solution for your Formulation, PUPSIT, and Final Fill
Dhanu Angga Kumara

Final formulation, final filtration with PUPSIT implementation, and final fill are typically the concluding steps in biologics manufacturing. These critical processes require a balance of product safety, regulatory compliance, and operational efficiency. Discover how single-use assemblies can enhance and streamline these essential stages.

  • Dhanu Angga Kumara (Technical Application Expert at PT Merck Chemicals and Life Sciences)

    Dhanu Angga Kumara

    Technical Application Expert at PT Merck Chemicals and Life Sciences
Lunch
Practical aspects of Pre-Use Post Sterilization Integrity Testing (PUPSIT) implementation
Somasundaram G.

The ultimate measure of a sterilizing filter’s performance is bacterial retention. Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. FDA Guidelines require integrity testing of filters used in the processing of sterile solutions such as biologics or small molecules. The FDA also requires corresponding testing documentation be included with batch product records. European regulatory position on PUPSIT is very clear, they treat Filtration is risky unit operation & hence they propose PUPSIT to be mandatory. US FDA drives more towards risk-based approach & Industry position considers PUPSIT adds risk to the process & may disrupt aseptic pathway, it also adds complexity & interventions during the aseptic filtration operation.
This session addresses the practical aspects of implementation in terms of pros & cons also provides pointers towards points to consider for risk assessments in accordance with Annex 1.

  • Somasundaram G. (Global Senior Consultant, Process Solutions at Merck KGaA)

    Somasundaram G.

    Global Senior Consultant, Process Solutions at Merck KGaA
Regulatory Inspection Coverage on CCS
Peter Qiu

This presentation will share some general considerations on implementing Contamination Control Strategy and FDA's regulatory assessment of facility's CCS during CMC review and on-site inspections. The presentation will then provide detailed discussions on each of the six systems covered during an inspection with the focus on assessing the facility's implementation of CCS.

  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Coffee Break
How to Minimize Risk of Microbial, Endotoxin and Particulates Contamination
Richard Chai

Minimizing the contamination risk is of utmost importance to prevent product contamination which can adversely affect patient safety. This presentation will provide a valuable insight into the use of quality risk management principles to identify and manage the contamination risk related to aseptic manufacturing process, from Annex 1’s perspective, as part of the overall Contamination Control Strategy.

The following topics are discussed in detail for this presentation:
· Annex 1 requirement on Contamination Control in aseptic manufacturing.
· Identification and management of contamination risks by microorganisms, endotoxin and particulates in aseptic manufacturing, including examples.

At the end of the presentation, the participants will have a better understanding on the Annex 1 requirement on contamination control, and also how to minimize risk of microbial, endotoxin and particulates contamination through the use of quality risk management principles on the identification, evaluation and control of potential risks to product quality to meet the Annex 1 requirements.

  • Richard Chai (Senior Technical Service Manager at STERIS Corporation)

    Richard Chai

    Senior Technical Service Manager at STERIS Corporation
The Challenges and Successful Annex 1 Implementation • A Bio Farma Case Study
Mira Mutia Meirani

The implementation of the Annex 1 guidelines in the sterile manufacture of pharmaceuticals represents a significant shift in regulatory requirements with the primary objective of enhancing product safety and quality. PT Bio Farma will share our experiences in developing and implementing the Contamination Control Strategies (CCS). The outline of our approach will include conducting a gap assessment and risk analysis, as well as designing, implementing, monitoring, with the aim to also improving the CCS. The presentation will also address key challenges and barriers encountered in adopting a holistic approach to ensure company compliance, the integration of advanced technologies, redesign both current and legacy facility, training personnel, and managing cross-functional teams to comprehensively address and mitigate contamination risks.

  • Mira Mutia Meirani (Manager of Quality Risk Management & Contamination Control Strategy at PT Bio farma)

    Mira Mutia Meirani

    Manager of Quality Risk Management & Contamination Control Strategy at PT Bio farma
The Challenges of PUPSIT Implementation • A Bio Farma Case Study
Undi Suhartono

Implementing the Pre Use Post Sterilization Integrity Test (PUPSIT) in the manufacturing process of sterile preparations raises new challenges regarding technical and regulatory aspects. Redesigning the line process, especially for old production lines, determining wetting agents, determining wetting duration, extending overall production time, and investing in additional equipment that burdens COGS are challenges manufacturers face. Requalification, revalidation, and recertification (if needed) are other quality system challenges that can disrupt the production schedule flow (product on hold). The case study of PUPSIT implementation at PT Bio Farma will take an example of implementation in the production line area of intermediate products (drug substances/medium) and final products (drug products), along with each challenge faced and what strategies are suggested or implemented to answer it.

  • Undi Suhartono (Head of Multiproduct Viral Bulk Production Department at PT Bio Farma (Persero))

    Undi Suhartono

    Head of Multiproduct Viral Bulk Production Department at PT Bio Farma (Persero)

The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.