SOP For Cleaning, Maintenance, and Calibration of Stability Chamber 1.0 Objective 1.1 To establish a procedure for the cleaning, maintenance, and calibration of stability chambers to ensure their proper functioning and reliability for stability studies. 2.0 Scope 2.1 This SOP is applicable to all stability chambers used in the Quality Control Department for storage of … Read more
SOP On Cleaning, Maintenance and Calibration of Cooling Cabinet 1.0 Objective 1.1 To lay down a procedure for the cleaning, maintenance, and calibration of the Cooling Cabinet to ensure proper functioning and reliability. 2.0 Scope 2.1 This SOP is applicable to the cleaning, maintenance, and calibration of the Cooling Cabinet used in the Quality Control … Read more
SOP for Handling of Alarm System of Stability Chambers 1.0 Objective 1.1 To lay down the procedure for handling and monitoring the alarm system of stability chambers to ensure prompt response in case of abnormal conditions such as temperature, humidity, or power supply failure. 2.0 Scope 2.1 This SOP is applicable to the operation and … Read more
SOP on handling of rinse and swab sample 1.0 Objective 1.1 To establish a procedure for the receipt, recording, analysis, and handling of rinse and swab samples in the Quality Control (QC) Department. 2.0 Scope 2.1 This SOP is applicable to the handling, documentation, and analysis of rinse and swab samples received in the Quality … Read more
SOP For Retesting of Primary Packaging Material (PPM) 1.0 Objective 1.1 To lay down the procedure for retesting of Primary Packaging Materials (PPM) to ensure their continued suitability and compliance with approved specifications before use. 2.0 Scope 2.1 This SOP is applicable to the retesting of Primary Packaging Materials in the Quality Control (QC) Department. … Read more
Analytical Instrument Qualification For HPLC System 1.0 Objective To lay down a procedure for qualification of the Shimadzu HPLC system to ensure that the instrument is installed correctly, operates as intended, and consistently performs according to predefined specifications and regulatory requirements. 2.0 Scope This procedure is applicable to qualification of Shimadzu High-Performance Liquid Chromatography (HPLC) … 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