The PDA Aseptic Manufacturing Excellence Conference 2025 (13–14 October, Melbourne) will be a premier gathering for professionals shaping the future of aseptic manufacturing. The event will bring together regulators, industry leaders, and innovators to explore how organisations can align with evolving international standards while adopting new...
The 2022 revision of the PIC/S Guide to GMP for Medicinal Products (PE 009-17) Annex 1 is expected to be adopted by the Therapeutic Goods Administration (TGA) in 2025 and Contamination Control Strategy (CCS) has emerged as a key new requirement. While CCS under Annex 1 is central for sterile drug manufacturers, it is also applicable for...
Personnel behaviour plays a significant role in the manufacture of sterile products. Aseptic processing occurs under a Laminar Air Flow, which is classified as a Grade A or ISO 4.8 environment. Disturbance of air in the Laminar Air Flow can affect the quality of the final product.
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