QA & QC

SOP on Testing Efficacy of Disinfectants. Objective: To lay down a procedure for testing efficacy of Disinfectants. Scope : This SOP is applicable for testing of efficacy of disinfectant solutions used in  microbiology laboratory and production area. Responsibility Microbiologist Head-Microbiology Accountability Head-Quality Control Head-Quality Assurance Procedure Prepare Culture suspension of …

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: …

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: …

Objective: To lay down the procedure for Viable Particulate Monitoring of Drain Points – Sterile Product Manufacturing Facility Scope: This SOP is applicable for Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability: Head …

Objective: To lay down a procedure for calibration of pH Meter. Scope: This SOP is applicable for calibration of pH Meter in quality control laboratory. Responsibility: Officer or above of QC laboratory is responsible for calibration of pH Meter Head Quality / nominee of QC department is responsible for reviewing …

Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance …

Investigating Out-of-Specification IDENTIFYING AND ASSESSING OOS TEST RESULTS — PHASE I: LABORATORY INVESTIGATION PHASE II:  FULL-SCALE OOS INVESTIGATION    

OBJECTIVE:To describe the calibration procedure for distribution of temperature within the chamber of Refrigerator. SCOPE: his SOP shall be applicable for Calibration of Refrigerator at Pharmaceutical Industries. RESPONSIBILITY :             Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control PROCEDURE : Operate the refrigerator as per Standard …