PROCEDURE FOR HANDLING OF EXTERNAL AUDITS OBJECTIVE: The purpose of this SOP is to lay …
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Cartridge filter -Integrity testing of SOP on
Cartridge filter -Integrity Testing SOP Objective: To lay down a procedure for integrity testing of …
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MICROMETER SCREW GAUGE
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PROCESS VALIDATION PROTOCOL OF TACROLIMUS CAPSULES
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Production and Process Controls
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CIP -Cleaning In Place
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SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER
SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN …
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HANDLING OF AUDIT TRAIL
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COMPUTERIZED SYSTEM LIFE CYCLE
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SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS
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HANDLING OF PHARMACOPOEIAL CHANGES
Recent Posts
March, 2024
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7 March
COMPUTERIZED SYSTEM LIFE CYCLE
COMPUTERIZED SYSTEM LIFE CYCLE PURPOSE: The purpose of this procedure is to define the system life cycle methodology that shall be used while implementing GxP computerized system to ensure that system remains in state of validation throughout the system life cycle. SCOPE: This SOP is applicable for all GxP computerized …
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7 March
VIRTUAL INSPECTION
VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual inspection in order to determine the effectiveness of the systems, system compliance and to identify the opportunities for continual improvement as per current regulatory requirements. SCOPE: This SOP is applicable for conducting virtual inspection of …
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4 March
AUDIT OBSERVATIONS
AUDIT POINT Warehouse: Pictorial presentation not available in sampling change room (Minor) Manufacturer released /approved label not defaced (Minor) Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor) Dispensing scoop status label not available of cleaned on, previous product, Use up …
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3 March
VERIFICATION AND TESTING OF FINISHED GOODS
VERIFICATION AND TESTING OF FINISHED GOODS PURPOSE: To provide the procedure for testing of finished Goods at outside laboratory and physical verification to ensure that product is complies with specification criteria. SCOPE: This Procedure is applicable for finished product testing at outside lab and receive at depot. Procedure for Physical …
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2 March
SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS
SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS PURPOSE: To define a procedure for shelf life extension of existing commercialized products. SCOPE: This procedure shall be applicable for shelf life extension of existing commercialized products which comprises volumes of Domestic market. RESPONSIBILITY: Site Quality Assurance To provide stability study data for …
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