SOP on Sampling of intermediates and finished products in pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE PREPARATION On completion of intermediate / finished product stage, check that the BMR /BPR is … Read more

Procedure for line clearances. Quality assurance.

OBJECTIVE To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross contamination / mix-ups (Line clearance). SCOPE The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. Responsibility In – process quality Assurance … Read more

SOP on Procedure for operation and cleaning of unit dosage sampler

SOP on Procedure for operation and cleaning of unit dosage sampler OBJECTIVE To lay down the procedure for operation and cleaning of unit dose sampler. SCOPE This SOP shall be applicable for IPQA area in Quality Assurance. RESPONSIBILITY In process Quality Assurance Executive /Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE FOR OPERATING Check the Status label … Read more

SOP on Handling of Out of Specification Results in quality control

SOP on Handling of Out of Specification Results in quality control OBJECTIVE To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing. SCOPE These procedures are applicable to all QC testing of raw materials, finished product, and stability samples. RESPONSIBILITY Analyst/ Quality Assurance Manager ACCOUNTABILITY Quality Assurance Manager PROCEDURE … Read more

SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company

SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company OBJECTIVE To lay down a procedure for Operation of Tablet Disintegration Tester (Make –Electrolab Model- ED2AL). SCOPE This Standard Operating Procedure (SOP) is applicable to test the disintegration time of the tablets during in process/ QC samples analysis. RESPONSIBILITY IPQA / QC/Production Executive / … Read more

SOP on Operating procedure for friability test appratus

OBJECTIVE To lay down a procedure for Operation of Friability Test Apparatus (Make – Electrolab Model-EF2) SCOPE This Standard Operating Procedure (SOP) is applicable to check the friability of In-process samples/QC samples. RESPONSIBILITY IPQA / QC/Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Clean the apparatus free of dust with dry cloth from out … Read more

SOP on Operating procedure for halogen moisture balance

OBJECTIVE To lay down a procedure for Operation of Halogen Moisture Balance SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Switch on the mains. Check the level of the instrument by checking the air bubble in level indicator is exactly in … Read more

SOP on Operating procedure for leak test apparatus in pharmaceutical company

OBJECTIVE To lay down a procedure for Operation of Leak Test Apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Ensure that the leak test apparatus is clean. Check that the desiccator is clean, if need be clean the dessicator … Read more

SOP on Operating procedure for vernier caliper in Pharmaceutical company

OBJECTIVE To lay down a procedure for Operation of Vernier Caliper SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE CLEANING Clean the apparatus with tissue paper after every use. OPERATING  INSTRUCTIONS  : Press the ON/OFF button to switch  on  the … Read more

Procedure for calibration of Instruments/ Equipments.Quality Assurance

OBJECTIVE : To lay down policy for calibration of Instruments/Equipments. RESPONSIBILITY : Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. There shall … Read more

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