Pharma Articles

Comprehensive Guide to Computer Software Assurance (CSA) in the Pharmaceutical Industry A. Introduction The pharmaceutical industry relies heavily on computerized systems for various critical functions, including production, quality control, data analysis, and recordkeeping. Ensuring the reliability and integrity of these systems is paramount for patient safety and product quality. This guide delves into Computer Software …

Comprehensive Guide to Computer Software Assurance (CSA) in the Pharmaceutical Industry Read More »

Standard Operating Procedure for Operation and Calibration of Sub Sieve Sizer 1.0 Purpose: To lay down a procedure for Operation and Calibration of Sub Sieve Sizer. 2.0 Scope: The scope of this procedure is applicable for Operation and Calibration of Sub Sieve Sizer, (Make Fisher Scientific; Model: 95), located in Quality Control laboratory at [company …

SOP for Operation and Calibration of Sub Sieve Sizer Read More »

Standard Operating Procedure for Writing of the Instrument Status Label in Quality Control Department 1.0 Purpose: To lay down a procedure for Writing of the Instrument Status Label in Quality Control Department. 2.0 Scope: The scope of this procedure is applicable for writing of the Instrument Status Label in Quality Control Department. 3.0 Responsibility: QC …

SOP for Writing of the Instrument Status Label in Quality Control Department Read More »

Standard Operating Procedure for Handling Out of Calibration 1.0 Purpose: To lay down a procedure for Handling out of Calibration observed in Quality Control Laboratory. 2.0 Scope: The Scope of this SOP is applicable for Handling out of Calibration observed in Quality Control Laboratory. 3.0 Responsibility: QC Personnel: To calibrate the instruments as per the …

SOP for Handling Out of Calibration Read More »

Standard Operating Procedure for Storage of under test samples in Quality Control Laboratory 1.0 Purpose: To lay down a procedure for Storage of under Test Samples in Quality Control Laboratory. 2.0 Scope: The scope of this procedure is applicable for Storage of under Test Samples (Raw Materials, Semi – Finished, Finished, Process Validation, Stability and …

SOP for Storage of under test samples in Quality Control Laboratory Read More »

Standard Operating Procedure for Verification of Tablet Hardness Tester 1.0 Purpose: To lay down a procedure for Verification of Tablet Hardness Tester. 2.0 Scope: The scope of this SOP is applicable for Verification of Tablet Hardness Tester at Quality control department. 3.0 Responsibility: QC Personnel: To Verify the Tablet Hardness Tester. Section Head QC/Designee: To …

Standard Operating Procedure for Verification of Tablet Hardness Tester Read More »

Standard Operating Procedure for Operation of Pin Hole Tester 1.0 Purpose: To lay down a procedure for Operation and Cleaning of Pin Hole Tester. 2.0 Scope: The scope of this SOP is applicable for Operation and Cleaning of Pin Hole Tester. 3.0 Responsibility: QC Personnel: Operation and Cleaning of Pin Hole Tester. Head QC/ Designee: …

SOP for Operation of Pin Hole Tester Read More »

Standard Operating Procedure for Reporting of Raw Material and Working Standard Potency 1.0 Purpose: To lay down a procedure for providing the Potency of Active Raw Material (API) to Warehouse Department before Dispensing. 2.0 Scope: The scope of this procedure is applicable for providing the Potency of Active Raw Material (API) to Warehouse Department. It …

SOP for Reporting of Raw Material and Working Standard Potency Read More »

Standard Operating Procedure for Operation and Calibration of Osmometer 1.0 Purpose: To lay down a procedure for Operation and Calibration of Osmometer. 2.0 Scope: The scope of this SOP is applicable for Operation, Cleaning and Calibration of Osmometer, Make – Gonotec, Model – OSMOMAT 030. 3.0 Responsibility: QC Personnel: To Operate, Clean and Calibrate Osmometer., …

SOP for Operation and Calibration of Osmometer Read More »

Scroll to Top