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INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

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INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument Calibration Verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion … Read more

PERFORMANCE QUALIFICATIONS FOR RAPID MIXER GRANULATOR

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 Protocol Preparation and Approval Preparation and Checking:   Validation Team Prepared by Checked by Dept QC QA Stores Stores QC QA Name             Signature             Date               Approval:    Approved by Plant Head Head- Quality Control Head- Quality Assurance Name … Read more

Assigning of repack before date

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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 … Read more

Cleaning of Sampling Aids

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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 … Read more

PROCEDURE FOR CALIBRATION OF DISINTEGRATION TEST APPARATUS

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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 … Read more

Factory Acceptance Test for Fluid Bed Dryer

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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 … Read more

CALIBRAITON PROCEDURE FOR GAS CHROMATOGRAPH CLARUS 500 WITH HEAD SPACE (Perkin Elmer)

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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 … Read more

AREA QUALIFICATION PROTOCOL

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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 … Read more

Site Acceptance Test Protocol for Sifter 36” Vibro Type

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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         … Read more

Site Acceptance Test Protocol for Blister Pack Machine

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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 … Read more