ISO 14644: Cleanrooms and associated controlled environments ISO 14644 is a series of international standards that specify cleanliness classes for airborne particles in cleanrooms and controlled environments. It defines the maximum allowable particle concentrations in the air based on particle size. This standard helps ensure uniformity in cleanroom classifications and is widely used across Clean Room Validation industries. EU GMP (Good Manufacturing Practice) Annex 1: Manufacture of Sterile Medicinal Products Annex 1 of the EU GMP guidelines specifically addresses the requirements for the manufacture of sterile medicinal products. It provides guidelines for cleanroom design, qualification, and ongoing monitoring to ensure aseptic manufacturing.

US FDA (Food and Drug Administration) Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing The FDA provides guidance for pharmaceutical manufacturers on the requirements for sterile drug products produced by aseptic processing. It outlines the principles and controls necessary to ensure the sterility and quality of such products, including cleanroom validation. PIC/S (Pharmaceutical Inspection Co-operation Scheme) Guide to Good Manufacturing Practice for Medicinal Products PIC/S is a cooperative arrangement between regulatory authorities, and its guide provides recommendations for the manufacture of medicinal products, including sterile products and cleanroom operations.

Click Here: https://isspllab.com/clean-room-validation-a-small-investment-for-long-term-gains/