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…
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…
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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Factory Acceptance Test for Fluid Bed Dryer Machine name : FALCON FLUID BED DRYER Client Name & address : FALCON, AHMEDABAD, INDIA Document name : factory acceptance test PROTOCOL No. : Revision no. : 00 MACHINE SR. NO. : Table of Contents 1.… SYSTEM DESCRIPTION & SALIENT FEATURES :……………………………………………………………. 2.… SYSTEM CHECKS :…………………………………………………………………………………………………………… 2.1 Physical…
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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AREA QUALIFICATION PROTOCOL LOCATION : AREA : AREA CODE : REF. FACILITY VALIDATION PROTOCOL NO.: PREPARED BY: NAME SIGNATURE DATE APPROVED BY: NAME SIGNATURE DATE Area in Sq.Ft : To be used for : PARAMETER SPECIFICATION VERIFICATION REMARKS A] CIVIL WORKS:- Carryout the following checks with respect to civil works. WALLS: WALL MATERIAL…
Site Acceptance Test Protocol for Sifter 36” Vibro Type Machine Name : SIFTER 36” VIBRO TYPE Client Name & Address : FALCON, AHMADABAD, INDIA Document Name : Site Acceptance Test Protocol PROTOCOL No. : Revision no. : 00 MACHINE SR. NO. : Table of contents Sr. No. Title Page No. 1.0 Approval Sheet 03 2.0 …
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Site Acceptance Test Protocol for Blister Pack Machine machine name : BLISTER PACK MACHINE. Client Name & address : M/S BLISCARE MACHINES, MUMBAI. document name : SITE acceptance test PROTOCOL PROTOCOL no. : Revision no. : MACHINE SR. NO. : Table of contents Sr. No. Title Page No. 1.0 Approval Sheet 03 2.0 Purpose 04…
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FACTORY ACCEPTANCE TEST FOR BIN BLENDER machine name : BIN BLENDER (600 LTRS) Client Name & address : SAIMACH PHARMATECH PVT LTD document name : factory acceptance test PROTOCAL no. : SCT/FAT/002 Revision no. : 00 MACHINE SR. NO. : Table of Contents 1.0 SYSTEM DESCRIPTION 2.0 Physical Check 2.1 Basic Component Verification 3.0 VERIFICATION OF…
FACTORY ACCEPTANCE TEST FOR BLISTER PACK MACHINE machine name: BLISTER PACK MACHINE. Client Name & Address: M/S BLISCARE MACHINES, MUMBAI. document name: factory acceptance test Table of Contents SYSTEM DESCRIPTION & SALIENT FEATURES SYSTEM CHECKS : Physical Check : TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS OF SUBCOMPONENTS/BOUGHTOUTS MATERIAL OF CONSTRUCTION VENDOR & CLIENT REMARK SYSTEM DESCRIPTION :…
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