Process Validation Programme OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research Development to prepare and execute the validation protocol and to prepare a final report on Process Validation. Production to execute the…
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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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…
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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…
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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…
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…
