Category: SOPs

Preparation, Approval, Issue and Control of Artworks for labeling of drug products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue and Control of artworks for labeling of drug products intended for commercial use. RESPONSIBILITY : R&D(Packaging Development) to prepare the Artwork, positives or soft copy, and procure shade cards & specimens from the printers….

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Assigning of repack before date OBJECTIVE : To lay down the procedure for assigning of ‘repack before date’. RESPONSIBILITY :  Officer  Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE: The ‘repack before date’ shall be assigned from the day packing is initiated. The basis for period of repack before shall be on…

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Cleaning of Sampling Aids OBJECTIVE : To lay down a procedure for cleaning of Sampling Aids. RESPONSIBILITY : Officer – Quality Quality Assurance to implement the procedure. Head – Quality Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA 02 Neutral, solution). To about 980 mL of potable water in…

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OBJECTIVE : To lay down a procedure for Calibration of Disintegration test apparatus. SCOPE : This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in Quality Control. RESPONSIBILITY:IPQA / Production Executive / Officer  ACCOUNTABILITY : Head –Quality Assurance PROCEDURE Check the water level in the water bath. Fill the water in the beakers up…

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CALIBRAITON PROCEDURE FOR GAS CHROMATOGRAPH CLARUS 500 WITH HEAD SPACE (Perkin Elmer) OBJECTIVE : To lay down the procedure for calibration of  GC  Clarus 500 with head space (Perkin Elmer ) SCOPE : This SOP shall be applicable for the GC Clarus 500 with head space (Perkin Elmer). RESPONSIBILITY: Quality Control Executive/Officer. ACCOUNTABILITY: Head Quality Control. CALIBRATION PARAMETERS Oven…

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Handling of Out of Specification Results 1.0 OBJECTIVE: To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing. 2.0 SCOPE : These procedures are applicable to all QC testing of raw materials, finished product, and stability samples. 3.0 RESPONSIBILITY : Analyst/ Quality Assurance Manager 4.0 ACCOUNTABILITY : Quality Assurance Manager 5.0…

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PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER 1.0  OBJECTIVE :  To lay down the procedure for operation and cleaning of unit dose sampler. 2.0  SCOPE :  This SOP shall be applicable for IPQA area in Quality Assurance. 3.0  RESPONSIBILITY : In process Quality Assurance Executive /Officer 4.0  ACCOUNTABILITY : Head Quality Assurance 5.0  PROCEDURE FOR OPERATING…

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SAMPLING OF PACKING MATERIALS 1.0  OBJECTIVE : To lay down a procedure for sampling of packaging materials. 2.0  SCOPE : To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. 3.0  RESPONSIBILITY :Quality Control Executive/Officer 4.0 ACCOUNTABILITY : Quality…

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PROCEDURE FOR CLEANING AND STORAGE OF SAMPLING DEVICES. OBJECTIVE :  To lay down the procedure for Cleaning and storage of sampling devices. SCOPE :  This SOP shall be applicable for  Cleaning of all type of Sampling devices. RESPONSIBILITY : Quality Control Technician ACCOUNTABILITY :Executive / Officer – Quality Control PROCEDURE After the sampling, keep the sampling…

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SAMPLING OF RAW MATERIALS 1.0 OBJECTIVE : To lay down a procedure for sampling of Raw Materials so as to get a representative sample of the whole lot for analysis. 2.0 SCOPE : This SOP shall be applicable to sampling of all Raw materials. 3.0 RESPONSIBILITY : Quality Control Executive/Officer 4.0 ACCOUNTABILITY : Head Quality Assurance…

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