Hvac Validation
This document was uploaded by user and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this DMCA report form. Report DMCA
Overview
Download & View Hvac Validation as PDF for free.
More details
- Words: 819
- Pages: 20
Loading documents preview...
GMP Facility HVAC & Critical Services Validation Presented by Darren Green
VMP
SOP’s
The “V” Diagram
URS
PQ
FRS
DQ
DS
IQ
Implement 2
User Requirement Spec (URS) z Identifies
GMP Critical Factors z Each Item – Unique – Individually Testable – Basis of Test identified
z Individually
Numbered z Traceable to FRS 3
URS For HVAC z z z z z z z z
Regulatory Basis GMP Critical Functions Temperature Humidity Particulates Pressure Control Micro Dust Extraction
z z z z z z
Cross Contamination Control Reason for selection as GMP Critical How are functions to be measured Is there a Computer Involved What is to be alarmed What happens on alarm 4
URS For Other Services z z z z z z
Dust Extraction GMP Critical Functions Inlet Velocity Flow Rate Effect on HVAC Pressure Control Exhaust Filter Rating
z z z z z z
Compressed Air GMP Critical Functions Particulates Hydrocarbons Pressure Dryness
5
URS For Other Services z z z z z z z z z
Purified Water / WFI GMP Critical Functions USP or EP Conductivity Flow Rate TOC CFU Endotoxins Temperature
z z z z
Clean Steam GMP Critical Functions Condensate meets WFI Criteria Pressure
6
REMEMBER
URS SETS UP PQ TEST REQUIREMENTS AND SETS THE BASIS FOR THE FRS
Functional Requirements Specification (FRS) z
z z z
Define Maximum Acceptance Range per parameter per functional space Define Alarm points per parameter Remember to define a period for alarms Nominate the test type
z
z z
z
Relate Each Requirement to a URS item Provide Design Constraints separately Can be combined with Design Spec on smaller jobs Traceable to Design Spec 8
REMEMBER
FRS SETS UP OQ TEST REQUIREMENTS AND SETS UP THE BASIS FOR THE DS
Design Specification (DS) z z z z z z
Detailed Technical Information for Purchase and Installation, including Drawings. Set Design Control Limits tighter than GMP Acceptance Limits set in URS and FRS Provide for early Warning Alarms so that there is time to act before GMP alarms occur Address Occupational Health and Safety matters Suitable for Audit as well as Tender Traceable to FRS 10
REMEMBER
DESIGN SPEC SETS UP IQ TEST REQUIREMENTS
Installation Qualification (IQ) z z z z z
Formal Record the what was specified in Design Spec has been supplied and installed correctly Records Tag No, Make, Model, Serial No, etc for entire installation Defines GMP Critical Instrumentation Provides Evidence of Integrity of Installed Items. Include an Air Schematic to show relationships
12
Typical HVAC IQ Table of Contents z z z z z z z z z z
1. SIGNATURE RECORD 2. ABBREVIATIONS AND DEFINITIONS 3. MODIFICATIONS MADE DURING QUALIFICATION 4. QUALIFICATION INTRODUCTION 5. IQ OBJECTIVES 6. SCOPE 7. COMPONENT INFORMATION 8. MATERIALS OF CONSTRUCTION 9 PRODUCT CONTACT MATERIALS, FILTERS AND ENVIRONMENTAL FILTERS 10 OPERATION & MAINTENANCE MANUALS DISTRIBUTION LIST 13
Typical HVAC IQ Table of Contents z z z z z z z z
11. LIST OF CERTIFICATES OF CONFORMITY 12. SERVICES INFORMATION 13. PRE-START CHECKS 14. CALIBRATION SCHEDULE 15. CONCLUSIONS & APPROVAL 16. LIST OF APPENDICES 17. REFERENCED DOCUMENTS APPENDICES
14
Operational Qualification (OQ) z
z z
Formal Record that testing has proved that the system can operate consistently and reliably within the Limits set out in the FRS Tests need only address the GMP critical Functions. Other non critical functions can be commissioned and recorded to good engineering standards but do not need to appear in the OQ 15
Typical HVAC OQ Table of Contents z z z z z z z z z
1. SIGNATURE RECORD 2. ABBREVIATIONS AND DEFINITIONS 3. MODIFICATIONS MADE DURING QUALIFICATION 4. QUALIFICATION INTRODUCTION 5. OPERATIONAL QUALIFICATION OBJECTIVE 6. SCOPE 7. PROCEDURES 8. SAFETY 9. CALIBRATION 16
Typical HVAC OQ Table of Contents
z 10 OPERATIONAL QUALIFICATION TESTS
10.1 Review of Contractor’s Commissioning Report 10.2 Supply and Extract Air Volume Flow Rates 10.3 Calculation of Air Change Rates and Outside Air % 10.4 Determination of Room Absolute and Differential Pressures – 10.5 Room Particle Count Test (at rest) – 10.6 Temperature, Relative Humidity Test – – – –
z z z z
11. CONCLUSIONS AND APPROVALS 12. LIST OF APPENDICES 13. REFERENCED DOCUMENTS APPENDICES 17
Performance Qualification (PQ) z
z
For Solid Dose HVAC generally replaced by the ongoing procedures (SOP’s) to be used to ensure that the system stays within acceptance limits during normal operation and over time. For Sterile HVAC the establishment of ongoing microbial compliance during operation and the regular monitoring and responses that ensure that the system is within control limits during manufacture including the measures that will identify any faults. 18
What Documentation is Required z z z z z z z z
Validation Master Plan (VMP) User Requirement Specifications (URS) Functional Requirements Specifications (FRS) Design / Detailed Specifications (DS) Installation Qualifications (IQ) Operational Qualifications (OQ) Performance Qualifications (PQ) Standard Operating Procedures (SOP) 19
Thank You for your Attention
VMP
SOP’s
The “V” Diagram
URS
PQ
FRS
DQ
DS
IQ
Implement 2
User Requirement Spec (URS) z Identifies
GMP Critical Factors z Each Item – Unique – Individually Testable – Basis of Test identified
z Individually
Numbered z Traceable to FRS 3
URS For HVAC z z z z z z z z
Regulatory Basis GMP Critical Functions Temperature Humidity Particulates Pressure Control Micro Dust Extraction
z z z z z z
Cross Contamination Control Reason for selection as GMP Critical How are functions to be measured Is there a Computer Involved What is to be alarmed What happens on alarm 4
URS For Other Services z z z z z z
Dust Extraction GMP Critical Functions Inlet Velocity Flow Rate Effect on HVAC Pressure Control Exhaust Filter Rating
z z z z z z
Compressed Air GMP Critical Functions Particulates Hydrocarbons Pressure Dryness
5
URS For Other Services z z z z z z z z z
Purified Water / WFI GMP Critical Functions USP or EP Conductivity Flow Rate TOC CFU Endotoxins Temperature
z z z z
Clean Steam GMP Critical Functions Condensate meets WFI Criteria Pressure
6
REMEMBER
URS SETS UP PQ TEST REQUIREMENTS AND SETS THE BASIS FOR THE FRS
Functional Requirements Specification (FRS) z
z z z
Define Maximum Acceptance Range per parameter per functional space Define Alarm points per parameter Remember to define a period for alarms Nominate the test type
z
z z
z
Relate Each Requirement to a URS item Provide Design Constraints separately Can be combined with Design Spec on smaller jobs Traceable to Design Spec 8
REMEMBER
FRS SETS UP OQ TEST REQUIREMENTS AND SETS UP THE BASIS FOR THE DS
Design Specification (DS) z z z z z z
Detailed Technical Information for Purchase and Installation, including Drawings. Set Design Control Limits tighter than GMP Acceptance Limits set in URS and FRS Provide for early Warning Alarms so that there is time to act before GMP alarms occur Address Occupational Health and Safety matters Suitable for Audit as well as Tender Traceable to FRS 10
REMEMBER
DESIGN SPEC SETS UP IQ TEST REQUIREMENTS
Installation Qualification (IQ) z z z z z
Formal Record the what was specified in Design Spec has been supplied and installed correctly Records Tag No, Make, Model, Serial No, etc for entire installation Defines GMP Critical Instrumentation Provides Evidence of Integrity of Installed Items. Include an Air Schematic to show relationships
12
Typical HVAC IQ Table of Contents z z z z z z z z z z
1. SIGNATURE RECORD 2. ABBREVIATIONS AND DEFINITIONS 3. MODIFICATIONS MADE DURING QUALIFICATION 4. QUALIFICATION INTRODUCTION 5. IQ OBJECTIVES 6. SCOPE 7. COMPONENT INFORMATION 8. MATERIALS OF CONSTRUCTION 9 PRODUCT CONTACT MATERIALS, FILTERS AND ENVIRONMENTAL FILTERS 10 OPERATION & MAINTENANCE MANUALS DISTRIBUTION LIST 13
Typical HVAC IQ Table of Contents z z z z z z z z
11. LIST OF CERTIFICATES OF CONFORMITY 12. SERVICES INFORMATION 13. PRE-START CHECKS 14. CALIBRATION SCHEDULE 15. CONCLUSIONS & APPROVAL 16. LIST OF APPENDICES 17. REFERENCED DOCUMENTS APPENDICES
14
Operational Qualification (OQ) z
z z
Formal Record that testing has proved that the system can operate consistently and reliably within the Limits set out in the FRS Tests need only address the GMP critical Functions. Other non critical functions can be commissioned and recorded to good engineering standards but do not need to appear in the OQ 15
Typical HVAC OQ Table of Contents z z z z z z z z z
1. SIGNATURE RECORD 2. ABBREVIATIONS AND DEFINITIONS 3. MODIFICATIONS MADE DURING QUALIFICATION 4. QUALIFICATION INTRODUCTION 5. OPERATIONAL QUALIFICATION OBJECTIVE 6. SCOPE 7. PROCEDURES 8. SAFETY 9. CALIBRATION 16
Typical HVAC OQ Table of Contents
z 10 OPERATIONAL QUALIFICATION TESTS
10.1 Review of Contractor’s Commissioning Report 10.2 Supply and Extract Air Volume Flow Rates 10.3 Calculation of Air Change Rates and Outside Air % 10.4 Determination of Room Absolute and Differential Pressures – 10.5 Room Particle Count Test (at rest) – 10.6 Temperature, Relative Humidity Test – – – –
z z z z
11. CONCLUSIONS AND APPROVALS 12. LIST OF APPENDICES 13. REFERENCED DOCUMENTS APPENDICES 17
Performance Qualification (PQ) z
z
For Solid Dose HVAC generally replaced by the ongoing procedures (SOP’s) to be used to ensure that the system stays within acceptance limits during normal operation and over time. For Sterile HVAC the establishment of ongoing microbial compliance during operation and the regular monitoring and responses that ensure that the system is within control limits during manufacture including the measures that will identify any faults. 18
What Documentation is Required z z z z z z z z
Validation Master Plan (VMP) User Requirement Specifications (URS) Functional Requirements Specifications (FRS) Design / Detailed Specifications (DS) Installation Qualifications (IQ) Operational Qualifications (OQ) Performance Qualifications (PQ) Standard Operating Procedures (SOP) 19
Thank You for your Attention
Related Documents
Hvac Validation
January 2021 2
Hvac
January 2021 5
Validation Autoclave
February 2021 0
Hvac Course
March 2021 0
Validation Letter
February 2021 0
Hvac Qualification
January 2021 1More Documents from "MuhammadAteeq"