SOP on Out of Specification (OOS) Results in Microbiology Laboratory 1.0 Objective To establish a systematic procedure for reporting, investigation, evaluation, and disposition of Out of Specification (OOS) results generated in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to OOS results arising from: Microbial Limit Test (MLT) Sterility Testing Bacterial Endotoxin Test … Read more
SOP For Handling of Microbiological Data Deviation (MDD) in Microbiology Laboratory 1.0 Objective 1.1 To lay down a systematic procedure for identification, reporting, investigation, evaluation, and closure of Microbiological Data Deviations (MDD) observed in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to all microbiological deviations arising from the following activities: Environmental Monitoring … Read more
SOP on Container Closure Integrity Testing (CCIT) for Dry Powder for Injection 1.0 Objective 1.1 To lay down the procedure for performing Container Closure Integrity Testing (CCIT) for Dry Powder for Injection using Chemical (Dye Ingress) Method and Microbial Challenge Study. 2.0 Scope 2.1 This SOP is applicable to Container Closure Integrity Testing of Dry … Read more
SOP FOR ANALYST QUALIFICATION FOR MICROBIOLOGICAL ANALYSIS 1.0 OBJECTIVE To establish a standardized procedure for qualification and requalification of analysts performing microbiological analysis to ensure competency, accuracy, and compliance with regulatory requirements. 2.0 SCOPE This SOP applies to all microbiologists working in the Microbiology Department involved in microbiological testing activities. 3.0 RESPONSIBILITY 3.1 Trainee Officer … Read more
SOP for PROCEDURE FOR MICROBIAL LIMIT TEST 1.0 OBJECTIVE To establish a standardized procedure for determining microbial load, including specified pathogenic microorganisms, in raw materials and finished products using the Microbial Limit Test (MLT). 2.0 SCOPE This procedure applies to the analysis of microbial contamination and specified pathogens in raw materials and finished pharmaceutical products … Read more
SOP for Sampling of Raw Materials 1.0 OBJECTIVE To lay down a documented procedure for sampling of raw materials to ensure representative sampling, prevention of contamination, and compliance with Good Manufacturing Practices (GMP). 2.0 SCOPE This procedure is applicable to the sampling of all raw materials (Active and Excipients) received at the warehouse and sampled … Read more
SOP for Procedure for Analytical Method Validation and Verification 1.0 OBJECTIVE To establish a documented procedure for Analytical Method Validation and Verification in the Quality Control (QC) Department to ensure analytical methods are suitable for their intended purpose and comply with regulatory requirements. 2.0 SCOPE This SOP applies to all analytical method validation and verification … Read more
SOP for Stability Study of Volumetric Solutions 1.0 Objective To establish a standardized procedure for conducting stability studies of volumetric solutions to determine and assign their shelf life. 2.0 Scope This SOP is applicable to all volumetric solutions prepared and used in the Quality Control Laboratory. 3.0 Responsibility Chemist or above in the QC Laboratory … Read more
SOP for Chemical Analysis of Water Used in Manufacturing 1.0 Objective To establish a standardized procedure for the chemical analysis of water used in manufacturing to ensure compliance with approved specifications. 2.0 Scope This SOP is applicable to the Quality Control Laboratory for performing chemical analysis of water samples used in manufacturing processes. 3.0 Responsibility … Read more
Key checklist of WHO TRS 1044-annex-2 For products that have been filled aseptically, samples should include containers filled at the beginning and end of the batch. Additional samples (for example, taken after critical interventions) should be considered based on risk. For products that have been heat sterilized in their final containers, samples taken should be … Read more