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…
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…
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…
PROCEDURE FOR VIABLE AIR MONITORING 1.0 OBJECTIVE : To lay down a procedure for environmental monitoring of air. 2.0 SCOPE : This SOP shall provide the procedure for monitoring the viable air borne count in unit II. 3.0 RESPONSIBILITY : Quality Control Executive / Officer. 4.0 ACCOUNTABILITY : Head Quality Assurance. 5.0 PROCEDURE The microbial environmental conditions of…
PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER 1.0 OBJECTIVE : To lay down a procedure for microbiological monitoring of raw water and purified water. 2.0 SCOPE :This SOP shall provide the procedure for sampling and testing of raw water, soft water and purified water from all the user points and all the points across the critical functions…
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IN-PROCESS CONTROL OF PACKING LINE 1.0 OBJECTIVE : To ensure quality of Finished Products during strip packing and final packing operation of tablets. 2.0 SCOPE: This SOP shall be applicable in-process controls during strip packing and final packing operation of tablets. 3.0 RESPONSIBILITY In process Quality Assurance Officer / Executive. 4.0 ACCOUNTABILITY : Head Quality Assurance 5.0 …
SAMPLING OF INTERMEDIATES AND FINISHED PRODUCTS 1.0 OBJECTIVE : To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. 2..0 SCOPE : This SOP shall be applicable to the IPQA in Quality Assurance Department. 3.0 RESPONSIBILITY : In process Quality Assurance Executive/Officer 4.0 ACCOUNTABILITY : Head Quality Assurance 5.0 …
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IN-PROCESS CONTROL DURING TABLET MANUFACTURING 1.0 OBJECTIVE :To lay down the procedure for In process Controls during Tablet Manufacturing. 2.0 SCOPE :This SOP shall be applicable for in process controls during tablets manufacturing/ This SOP shall be applicable to IPQA in Quality Assurance Department. 3.0 RESPONSIBILITY In process Quality Assurance Executive/Officer. 4.0 ACCOUNTABILITY Head Quality…
