Validation & Qualification

Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS Approval Objective Responsibility System Description – Equipment Identification & Description of Operation Standard Operating Procedure Established During Operation Qualification Validation Plan and Methodology Performance Qualification Procedure -1.Effect of Sealing Temperature 2. Effect of Sealing Temperature 3.Effect of Vibration Deviation and …

SOP for Performance Qualification for Auto Coater 48’’ GMP Model TABLE OF CONTENTS 1.Approval 2.Objective 3.Responsibility 4.System Description – 1.Equipment Identification 2.Description of Operation 5.Standard Operating Procedure  Established During Operation Qualification 6.Validation Plan and Methodology 7.Performance Qualification Procedure Gun Distance from Bed RPM of Peristaltic pump and Spray Rate Effect …

SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN Content Approval sheet Introduction Objective Computerized Systems Validation Policy Scope Definitions Role and responsibilities Identification And Categorization of Computerized Systems Validation Strategy and Deliverables Supplier Assessment Quality Risk Management Validation Requirements Documentation Change Control Training Maintenance and Support Document Completion Procedure System Retirement …

Compression Machine FAT (Factory Acceptance Test) Compression Machine FAT – The purpose is to identify the quality acceptance tests performed at the suppliers’ facilities. Ensuring the compression runs well at startup is an important role of the equipment supplier. Proper design and fabrication are critical, but equally important is a …

OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Pre-Approval Overview Purpose Requalification System Distribution System Description Operational Qualification Procedure Pre Requisite for OQ Test Test Equipments Qualification of Execution Team Inspection Checklist Operational Qualification Instrument Calibration Key Functionality Operational Checks SOP verification Deficiency, if any …

INSTALLATION   QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 Abbreviations …

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM TABLE OF CONTENTS DESIGN QUALIFICATION PROTOCOL APPROVAL INTRODUCTION OBJECTIVE: SCOPE RESPONSIBILITY BASIS OF DESIGN SYSTEM DESCRIPTION SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS PANEL INTERLOCKS AND OPERATIONAL LOGICS CRITICAL SAFETY REQUIREMENTS SAMPLING PLAN SANITISATION CYCLE LIST OF APPROVED MAKES DESIGN QUALIFICATION APPROVAL …

Validation Observations Recording Format -I for steam sterilizer and load Pattern Recording Of Observations For Revalidation 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 of gas collected in the burette (Vb) and the …

Performance Qualification Report for steam sterilizer 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 …

Load Pattern & Justification for steam sterilizer 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 …

Protocol for steam sterilizer and load Pattern MODEL :HORIZONTAL-RECTANGULAR LOCATION :VIAL WASHING ROOM TABLE OF CONTENTS Protocol Approval Objective Scope Equipment Description Responsibilities And Identification Of Execution Team Test Procedures Recording Of Observations Discrepancy And Corrective Action Report Compilation, Review And Summary Report Appendix Revalidation Criteria Schematics of Stem Quality …

Installation qualification for purified water generation system Purpose  The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that: Each installed sub-component complies with the engineering design and system data sheets/specifications. The system is installed according to the design …

Alu-Alu Blister Pack Machine Table of Contents General Salient Features Operational Requirements Utilities Maintenance Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL  General/Equipment No./Description/Use Required Specifications Equipment No. It contains Ø Base film-loading station. Ø Pre-forming base film platen heating station.. Ø Cold forming station. Ø Feeding systems which are …

Process Validation Guidance: FDA and Global OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process of …

New EU Requirements for Qualification & Validation Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/2015 3 Improved Annex 15 May be used as supplementary optional guidance …

Concept of URS,DQ,IQ,OQ,PQ in Pharma Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence …

Documentation in cleaning validation 1.0 Detailed cleaning procedure(s) are to be documented in SOPs 2.0 A Cleaning Validation Protocol is required to define how the cleaning process will be validated. It should include the following: The objective of the validation process; Responsibilities for performing and approving the validation study; Description …

Validation of Cleaning Processes  As a general concept, until the validation of the cleaning procedure has been completed, the product contact equipment should be dedicated. In a multi-product facility, the effort of validating the cleaning of a specific piece of equipment which has been exposed to a product and the …

Levels of Cleaning in cleaning Validation Introduction The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reaction and purification steps followed by physical changes. In general, early steps undergo further processing and purification and so potential carryover of the previous product would be removed. The level of cleaning …

Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL      Validation of Sterilization  Process in Autoclave (Loaded chamber)  Purpose : To provide the procedures to be followed for study of heat  distribution studies in loaded chamber of Autoclave.  Scope :  This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s used …