Validation & Qualification

 Label claim : Each uncoated modified release  tablet contains Gliclazide Ph. Eur …………60 mg                                 Master Formula No. :   Product Code :                              …

Compression Machine – Qualification (Operational) Compression Machine – Qualification (Operational) (OQ) involves identifying and inspecting equipment features that can impact final product quality Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by …

Compression Machine IQ (Installation Qualification) Compression Machine IQ is a documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist. Installation qualification of Compression machine IQ requirements for equipment includes …

OQ of Blister Packing Machine (BQS) TABLE OF CONTENT  Purpose Scope Responsibilities Procedure Operational qualification tests Testing of Programmable Logic Controller’s Processor Verification of Man Machine Interface Screens – MMI Power & Emergency Failure Recovery Verification Emergency Operation Verification Verification of Alarms Operational Qualification Tests Status List of Standard Operating …

IQ of Blister Packing Machine (BQS) TABLE OF CONTENT of IQ of Blister Packing Machine (BQS) 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 …

DQ of CONTA BLENDER TABLE OF CONTENT of DQ of CONTA BLENDER Objective Scope Responsibilities Machine description Operating control panel Main electric Panel Program of Bin Blender Program Data Program Spares Technical Specifications of Components & Sub-Components used/ bought outs Details of Utilities Identification of component for calibration Material of …

DQ for Purified Water System NAME OF THE  SYSTEM : PRETREATMENT & PURIFIED WATER GENERATION SYSTEM TABLE OF CONTENTS SR. NO. STAGE 1 OBJECTIVE & SCOPE 2 ACCEPTANCE CRITERIA 3 RESPONSIBILITY 4 SYSTEM DESCRIPTION  (SYSTEM AND SUB-SYSTEM) 5 BASIS OF DESIGN AND ASSUMPTION 6 TECHNICAL SPECIFICATIONS 7 DRAWINGS REQUIRED 8 SUPPORTING …

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 & MIST ELIMINATOR EXPLOSION FRAME & FLAP …

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) To design, engineer, and supply the Blister Packing Machine (Model: BQS) as per the URS and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there …

COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION) Table of Contents of compression machine URS General Salient Features Operational Requirements Utilities Maintenance Inspection and Testing Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL REQUIREMENT OF COMPRESSION MACHINE URS Equipment No. : To be embossed/imprinted conspicuously on the equipment Description:  37-station double rotary compression machine, …

SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA CONTENTS of PROCESS VALIDATION PROTOCOL Protocol Approval Sheet Objective Scope Responsibility Validation Team Members Abbreviations Pre-requisite for Validation Manufacturing Procedure Under Validation Critical Process Steps and Process Parameters for Validation with Justification Process steps – Sampling and Analysis Plan with Acceptance Criteria …