by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To define the procedure for proper cleaning of the Dry Heat Sterilizer (DHS) to prevent contamination and ensure compliance with GMP requirements. 2. Scope This SOP is applicable to the cleaning of DHS used for depyrogenation/sterilization of vials,...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To establish a standard procedure for monitoring non-viable airborne particulate matter in controlled manufacturing areas to ensure compliance with ISO 14644, EU GMP Annex 1, and regulatory requirements for sterile manufacturing. 2. Scope This SOP applies...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To establish a procedure for environmental monitoring of the manufacturing area to ensure controlled conditions and compliance with cGMP requirements. 2. Scope This SOP applies to all classified manufacturing areas (Grade A, B, C, and D) where sterile or...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility. 2.0 Scope This SOP applies to all trained personnel...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To establish a procedure for the proper operation, calibration, and maintenance of the METONE Laser Particle Counter (LPC) used for monitoring airborne particulate contamination in controlled areas. 2.0 Scope This SOP applies to all personnel trained to...
