PDA
無菌シンポジウム 2026

～ Advancing GMP and Annex 1: Practical Implementation and Future Directions ～

The “Symposium of Aseptic” has been held with the aim of supporting the effective implementation of PIC/S GMP Annex 1. In FY2024, the symposium focused on “Application of Advanced Practices in PIC/S GMP Annex 1,” followed in FY2025 by “Practical Implementation and Interpretation of PIC/S GMP Annex 1,” both of which were very well received.

This year, the symposium will be newly organized as the PDA Aseptic Manufacturing and Regulatory Science Symposium 2026 (Symposium of Aseptic 2026), co-hosted by PDA Headquarters, PDA Asia Pacific, and PDA Japan Chapter, and will be held over two days as an international symposium.

As the implementation of PIC/S GMP Annex 1, which came into effect in August 2023, continues to progress, the “2024 PDA Annex 1: One Year into Implementation Survey” has revealed discrepancies in interpretation and gap in understanding across countries, resulting in delays in practical implementation. In particular, harmonization of interpretation—including among regulatory authorities—is needed in areas such as Contamination Control Strategy (CCS), Aseptic Process Simulation (APS), Environmental Monitoring (EM), and barrier technologies.

In accordance with the above, Symposium of Aseptic 2026 will present the latest research and investigations under the theme “Advancing GMP and Annex 1: Practical Implementation and Future Directions.” The program will cover four categories:

1. Latest regulatory trends
2. Contamination Control Strategy (CCS)
3. Manufacturing of aseptic medicinal products
4. QC & QA

The symposium will feature numerous presentations by international speakers, a special invited lecture from PMDA on the status of PIC/S GMP Annex 1 Implementation Document, and sessions from  Aseptic Products GMP Committee on key points for Annex 1 implementation, related training, and industry trends. In addition, the program will include explanations of the latest regulatory and guideline developments—such as the 19th Edition of the Japanese Pharmacopoeia (Rapid Microbiological Methods and the Monocyte Activation Test)—along with technical information useful for practical implementation.

A large exhibition from companies involved in aseptic pharmaceuticals, biopharmaceuticals, and advanced therapy medicinal products is also planned.

We look forward to the participation of all professionals involved in aseptic pharmaceuticals, biopharmaceuticals, and advanced therapy medicinal products. This two-day symposium will surely be a valuable experience for you.

Dates: October 22 (Thu) – 23 (Fri), 2026

Venue: Congress Square Nakanoshima (inside Nakanoshima Cross, Osaka)