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- Parenteral Drug Association | Pharmaceutical Regulatory News | PDA
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PDA Technical Reports are highly valued, peer-reviewed global consensus documents written by subject-matter experts on issues relating to a wide array of challenging technical areas for pharmaceutical manufacturers
- PDA Miniverse: Medical Devices, Combination Products and Connected . . .
We warmly invite you to register for the PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2026, which will take place on 21-22 May 2026 in Dublin, Ireland
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- PDA Journal of Pharmaceutical Science and Technology
A Guide to Navigating Quality Control Requirements for Alternative and Rapid Microbial Methods in Sterility and Mycoplasma Testing Across the Asia Pacific Region Juliana Gutierrez PDA Journal of Pharmaceutical Science and Technology September 2025, pdajpst 2024-003031 1; DOI: https: doi org 10 5731 pdajpst 2024-003031 1 Add to Cart ($55) View more
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Accomplished by: Determining the number and resistance of naturally occurring microorganisms associated with the product • PDA Technical Monograph No 1 Calibrating Biological Indicators in order to challenge the process lethality Validating equipment and sterilization cycle
- ASEPTIC PROCESS SIMULATION (MEDIA FILL)
REFERENCES FDA Guidance for Industry- “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practices ” September 2004 PDA Technical Report No 22 – “Process Simulation for Aseptically Filled Products ” 2011 EU GMP Annex 1: Manufacture of Sterile Medicinal Products 2009
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