SOPs
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…
PROCEDURE FOR LINE CLEARANCES 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). 2.0 SCOPE: The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. 3.0 Responsibility…
