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Revalidation/requalification

Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals

Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals A formal change control system should be established to evaluate all changes that may affect production and control of the intermediate or API. There should be a written procedure …

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Qualification of existing facilities, systems, equipment and utilities

Qualification of existing facilities, systems, equipment, and utilities An existing facility has a mixture of new fully qualified equipment (DQ, IQ, OQ, PQ) and partially qualified/ unqualified equipment. Through many years of use, it can usually be shown that facilities, systems, equipment, and utilities can function to varied requirements. Nevertheless, …

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All Post URL of Drugs formulations

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

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Validation Observations Recording Format -I for steam steriliser and load Pattern

Recording Of Observations For Revalidation Identification Of The Executors   S. No. Name Designation & Department Sign & Date Training Details         Steam Quality Tests Steam Non-Condensable Gas Test When the temperature of the water in the container reaches 70-75°C close the needle valve. Note the volume …

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Performance Qualification Report for steam steriliser

REPORT APPROVAL Performance Qualification is verified that all test cases required by the protocol are completed, reconciled and included in the qualification summary report. Signatures in the block below indicate that all items in this Qualification Report have been reviewed and found to be acceptable. SUMMARY REPORT Data generated during …

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Load Pattern & Justification for steam steriliser

APPROVAL SIGNATURES Signing of this approval page of load pattern indicates agreement with the qualification approach described in PQ protocol. If any modification in the load pattern becomes necessary, a revision through change control shall be prepared, checked and approved. Wherever applicable revalidation of the modified load pattern shall be …

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Protocol for steam steriliser and load Pattern

DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL HORIZONTAL-RECTANGULAR SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE RUN No. TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Equipment Description 2.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording Of Observations …

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Revalidation Protocol Steam Sterizer

DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE RUN No.   TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Equipment Description 2.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording Of Observations …

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HVAC SYSTEM RE-QUALIFICATION PROTOCOL

HVAC RE-QUALIFICATION PROTOCOL TABLE OF CONTENT Sr.No Contents Page No 1. Approval sheet 2 2. objective 3 3. Scope 3 4. Responsibility 4 5. Qualification Team 5 6. Abbreviation and definition 5 7. Prerequisites 7 8. Precautions and instruction (Health, Safety and Environment) 7 9. Air velocity, Air volume and …

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