Validation & Qualification

Template for Process validation protocol Objective To provide documented evidence with high degree of assurance that the manufacturing process is capable of producing the finished product consistently of required quality, meeting its predetermined specifications and quality attributes. Scope   This process validation protocol is applicable to carry out process validation …

Installation qualification for pure steam generator OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and any auxiliary support systems, conforms to the Design parameters as per the Design Review. SCOPE  The tests shall be carried out at customer place. The verification of …

Operational qualification purified water generation system The purpose of this protocol (OQ protocol) is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with following feature but not limited to: The functional design specification to be address the permanent recording, …

Equipment Name: TUNNEL STERILIZER DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE   TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description 5.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording …

DESIGN QUALIFICATION OF BIN WASHING & DRYING SYSTEM TABLE OF CONTENT Objective Scope Responsibilities Machine description Operating control panel Main electric Panel Technical Specifications of Components & Sub-Components used/ bought outs Details of Utilities Identification of component for calibration Material of construction Enclosures Safety features and alarms Change control procedure …

DESIGN QUALIFICATION CARTONING MACHINE HI CART (BLISTER PACKING) TABLE OF CONTENT Objective Scope Responsibility (Client and manufacturer) Machine description Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control …

DESIGN QUALIFICATION AUTOMATIC CAPSULE FILLING MACHINE TABLE OF CONTENT  Objective Scope Responsibility (Client and manufacturer) URS (User Requirement Specification) Machine description Technical specification Technical specifications of the sub-components / bought out items Details of Utilities Identification of components for calibration Material of construction of components Surface area calculations for capsule …

DESIGN QUALIFICATION OF FLUID BED PROCESSOR TABLE OF CONTENT OBJECTIVE SCOPE RESPONSIBILITIES MACHINE DESCRIPTION FLUID BED DRYER FLUID BED PROCESSOR LOADING & UNLOADING OF MATERIAL EQUIPMENT SUBASSEMBLIES & PARTS MAIN BODY AIR INLET SHUT OFF VALVE BLOWER INLET SHUT OFF VALVE AIR PREPARATION UNIT PRODUCT CONTAINER & TROLLEY DEHUMIDIFIER & …

Compression Machine OQ (Operational Qualification) TABLE OF CONTENTS FOR COMPRESSION MACHINE OQ Approval Objective Responsibility System Description Pre-requisite of Operational Qualification Operational Qualification Procedure Training of concern personnel Critical Instrument Calibration Key Functionality Test Test Data Report Sheet Safety key Features Test SOP Verification Deviation Details(If Required) Change Control (If …

Tablet Compression Machine IQ (Installation Qualification) TABLE OF CONTENTS Approval Objective Responsibility Equipment Identification Equipment location Documentation Pre-requisite of Installation Qualification Installation Qualification Procedure System Description Procedure Installation Check List Inspection Check list Leveling and Alignment  Material of Construction Check Points Certificates for motor Drawing Identification of Standard Operating Procedures …

PERFORMANCE QUALIFICATION PROTOCOL OF WATER FOR INJECTION GENERATION AND DISTRIBUTION SYSTEM Protocol Contents 1.0 Protocol Approval  2. Overview 2.1Objective:  2.2 Purpose and Scope 2.3 Responsibility 2.4 Qualification Team 3.0 Traning Record 3.1 Purpose 3.2 Scope 4.0 Performance Qualification Requirements 5.0 System / Equipment Description 5.1 System / Equipment details 5.2 …

Performance Qualification Protocol of Tunnel Sterilizer TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description 5.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording Of Observations 8.0 Discrepancy And Corrective Action Report 9.0 Compilation, Review And Summary Report …

Installation Qualification for Vibratory Sifter (Single Deck) TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 Equipment Identification 5.0 Equipment location 6.0 Documentation 7.0 Pre-requisite of Installation Qualification 8.0 Installation Qualification Procedure 9.0 System Description 10.0 Procedure 10.1 Installation Check List 10.2 Inspection Check list 10.3 Leveling and Alignment  …

OPERATIONAL QUALIFICATION OF AIR COMPRESSOR PROTOCOL APPROVAL THE OQ PROTOCOL FOR AIR COMPRESSOR, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTS Prepared by: NAME SIGNATURE DATE Approved by: FUNCTION NAME SIGNATURE DATE VALIDATION PRODUCTION SERVICES QUALITY ASSURANCE Content 1. OBJECTIVE / PURPOSE 2. PREPARATION …

INSTALLATION QUALIFICATION PROTOCOL AIR COMPRESSOR PROTOCOL APPROVAL THE IQ PROTOCOL FOR AIR COMPRESSORS, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTSPrepared by: CONTENTS INSTALLATION QUALIFICATION PAGE 1.    OBJECTIVE / PURPOSE 2.    EQUIPMENT DESCRIPTION, IDENTIFICATION, AND CHECKS 3.    MAJOR COMPONENTS 4.    EQUIPMENT CONTROL SYSTEM 5.    …

PERFORMANCE QUALIFICATION PROTOCOL OF DISPENSING BOOTH TABLE OF CONTENT Description Page No Performance Qualification Protocol Approval Objective Scope Responsibility Pre requisite Reference  Testing Procedure   ·                     Airflow Laminarity by Smoke Test ·                     Non viable particle count ·                     Viable particle count Performance qualification summary and conclusion Abbreviation Performance Qualification Approval Particle …

OPERATIONAL QUALIFICATION PROTOCOL OF DISPENSING BOOTH TABLE OF CONTENT Purpose  Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Air Velocity Test  HEPA Filter Integrity Test Differential Pressure across Filters Operational Qualification Tests status List of Standard Operating Procedures Data Analysis, …

INSTALLATION QUALIFICATION PROTOCOL 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 …

OPERATIONAL QUALIFICATION PROTOCOL FOR COATING MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Variable RPM verification Operational Qualification Test Status List of Standard Operating Procedures Data Analysis, Summary of OQ & Recommendations Amendment record Conclusion …

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 Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion PURPOSE To describe the …