by Dr. Yashashwini Reddy | Sep 9, 2025
🧫 Typical Microbiology Concerns in an FDA Inspection 1. Environmental Monitoring (EM) Deficiencies Inadequate EM program for cleanrooms and controlled areas. Failure to establish alert/action limits based on historical data. Poor trending and lack of investigation of...
by Dr. Yashashwini Reddy | Aug 30, 2025
Standard Operating Procedure (SOP) for Operation of Colony Counter 1.0 Purpose To lay down the procedure for the proper operation of the colony counter for enumeration of microbial colonies on agar plates in order to ensure accuracy and consistency. 2.0 Scope This SOP...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for monitoring microbiological contamination in controlled areas using the settle plate (passive air sampling) method. 2. Scope This SOP is applicable to all classified areas (Grade A/B/C/D) in manufacturing and microbiology...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To define the procedure for calibration of the Slit-to-Agar Air Sampler used for environmental monitoring to ensure accurate measurement of microbial air contamination. 2. Scope This SOP applies to all STA air samplers used in microbiology or cleanroom...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for performing microbiological integrity testing of sealed vials to ensure container closure integrity and sterility assurance. 2. Scope This SOP applies to all finished sterile product vials manufactured in the facility that...
