• Key Learnings: Insights gained from the transition of the strategy program from its presentation at the previous conference to its current implementation and usage.
• Key Difficulties Faced During Implementation: Challenges encountered while putting the strategy program into practice.
• Management of Labs and Testing: Approaches and methods used to manage laboratory operations and testing procedures.
• Workload Management: Strategies employed to handle and distribute workload effectively.
• Digitalization as a Key Element: The role of digitalization in enhancing the efficiency and effectiveness of the strategy program.
• Managing Additional Requirements in Terms of E&L: How to address and incorporate additional requirements related to Extractables and Leachables (E&L).
• Additional Testing for Cured Silicone Elastomers (USP 383): Specific testing protocols for cured silicone elastomers as per USP 383 standards.
• Plastic Packaging Systems vs. Physicochemical Testing (USP 661.2): Comparison between plastic packaging systems and physicochemical testing requirements outlined in USP 661.2.
• Glass Container Requirements in Terms of Extractables (Future USP 660): Anticipated requirements for glass containers concerning extractables, as per the upcoming USP 660 standards.
• Metallic Packaging Systems (USP 662): Standards and testing requirements for metallic packaging systems according to USP 662.

Combination products became more prominent in recent decades as modern healthcare combines pharmaceuticals, medical devices and biologics. This session provides an introduction on the diversity of combination products and an overview of the standards and guidance that apply to them. Next, the session looks at an example combination product and the proposed ‘ideal’ extractables study design for the product which require a combination of approaches.

• Combination product diversity
• Which standards apply?
• Example combination product
• "Ideal" study design
• Summary & take-home messages

Container closure system is a crucial component of drug products. Changes in container closure system may have an impact on the quality, stability, and safety of drug product. Currently, regulatory agencies such as the NMPA, FDA, EMA, and ICH have issued regulations and guidelines specifying requirements for changes in container closure system. However, there are few reports on the equivalence research for packaging changes in marketed drugs. This topic focuses on the equivalence research of rubber closures, using multiple technical methods such as RS, IC, TGA-GC-MS, SEM-EDS and LC-MS. The research comprehensively analyzes the formulation system (inorganic fillers, vulcanization system, halide types, etc.), extractables, inorganic elements, and related physicochemical properties of 13 batches of halogenated butyl rubber stoppers for injection. It establishes the framework and testing methods for rubber closures equivalence research. The results of this research can be applied in evaluating for changes in container closure system and providing scientific evidence for new packaging components to meet their intended use.

• Background of research on equivalence of rubber closures
• Research practice on equivalence of rubber closures
• Summary and discussion on the equivalence of rubber closures

• Hospital pharmacies’ key asset is compounding drug products (DPs) to ensure continuous patient treatment.
• Compounding is done through nominal preparation, which involves short-term use tailored for individual patients, based on prescription, and batch production, which is a larger-scale preparation often lasting up to a year, simplifying intravenous services.
• A major challenge in batch compounding is the off-label use of plastic primary packaging, which can release harmful, and unmonitored leachable compounds, endangering patient safety.
• Key causes include a lack of awareness, financial constraints and inadequate regulations.
• Solutions include promoting awareness programs involving healthcare professionals, industry leaders, and regulators, encouraging analytical and toxicological assessments to ensure patient safety during DP administration, and finally advocating for proper use and regulation of plastic primary packaging in hospital compounding.
• This global issue, including Asia, demands urgent action to safeguard patient safety.

• The purpose was to develop a read-across methodology for extractables and leachables to derive health based exposure limits for compounds with limited toxicology data
• The methodology was based on responses from pharmaceutical companies surveyed on current E&L practices and read-across approaches, as well read-across literature from other industries
• Oral to parenteral bioavailability factors based on phys-chem properties were proposed for compounds lacking experimental and/or predicted bioavailability