by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for proper handling, storage, usage, and disposal of biological indicators (BIs) used to monitor and validate sterilization processes (steam, dry heat, ethylene oxide, hydrogen peroxide, etc.). 2.0 Scope This SOP applies to all...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the procedure for performing the Bowie-Dick test to assess steam penetration and air removal efficiency in steam sterilizers (autoclaves). 2.0 Scope This SOP applies to all steam sterilizers (autoclaves) used in pharmaceutical manufacturing,...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To establish a procedure for performing finger dab (finger imprint) tests for monitoring personnel hygiene practices and aseptic conditions in classified areas. 2.0 Scope This SOP applies to all personnel working in aseptic and controlled areas (Grades A,...
by Dr. Yashashwini Reddy | Aug 28, 2025
1. Purpose To define a standardized procedure to evaluate and verify the antimicrobial effectiveness of disinfectants and sporicidal agents used for routine cleaning and disinfection of classified and non-classified areas, equipment surfaces, and utilities in the...
by Dr. Yashashwini Reddy | Aug 18, 2025
Writing Effective SOPs in Pharmaceuticals Standard Operating Procedures (SOPs) are the backbone of pharmaceutical operations, ensuring consistency, compliance, and quality across all processes. An effective SOP must be clear, concise, and compliant with GMP (Good...
