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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