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GMP Facility

HVAC & Critical Services


Validation
Presented by Darren Green
VMP SOPs
The V Diagram
URS PQ

FRS DQ

DS IQ

Implement
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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

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URS For HVAC
z Regulatory Basis z Cross Contamination
z GMP Critical Functions Control
z Temperature z Reason for selection as
z Humidity GMP Critical
z Particulates z How are functions to be
measured
z Pressure Control
z Is there a Computer
z Micro Involved
z Dust Extraction z What is to be alarmed
z What happens on alarm
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URS For Other Services
z Dust Extraction z Compressed Air
z GMP Critical z GMP Critical
Functions Functions
z Inlet Velocity z Particulates
z Flow Rate z Hydrocarbons
z Effect on HVAC z Pressure
Pressure Control z Dryness
z Exhaust Filter Rating

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URS For Other Services
z Purified Water / WFI z Clean Steam
z GMP Critical Functions z GMP Critical
z USP or EP Functions
z Conductivity
z Condensate meets
z Flow Rate
WFI Criteria
z TOC
z Pressure
z CFU
z Endotoxins
z Temperature

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REMEMBER

URS SETS UP PQ TEST


REQUIREMENTS AND SETS THE
BASIS FOR THE FRS
Functional Requirements
Specification (FRS)
z Define Maximum z Relate Each
Acceptance Range per Requirement to a URS
parameter per item
functional space z Provide Design
z Define Alarm points Constraints separately
per parameter z Can be combined with
z Remember to define a Design Spec on
period for alarms smaller jobs
z Nominate the test type z Traceable to Design
Spec
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REMEMBER

FRS SETS UP OQ TEST


REQUIREMENTS AND SETS UP
THE BASIS FOR THE DS
Design Specification (DS)
z Detailed Technical Information for Purchase and
Installation, including Drawings.
z Set Design Control Limits tighter than GMP
Acceptance Limits set in URS and FRS
z Provide for early Warning Alarms so that there is
time to act before GMP alarms occur
z Address Occupational Health and Safety matters
z Suitable for Audit as well as Tender
z Traceable to FRS
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REMEMBER

DESIGN SPEC SETS UP IQ TEST


REQUIREMENTS
Installation Qualification (IQ)
z Formal Record the what was specified in Design
Spec has been supplied and installed correctly
z Records Tag No, Make, Model, Serial No, etc for
entire installation
z Defines GMP Critical Instrumentation
z Provides Evidence of Integrity of Installed Items.
z Include an Air Schematic to show relationships

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Typical HVAC IQ Table of
Contents
z 1. SIGNATURE RECORD
z 2. ABBREVIATIONS AND DEFINITIONS
z 3. MODIFICATIONS MADE DURING QUALIFICATION
z 4. QUALIFICATION INTRODUCTION
z 5. IQ OBJECTIVES
z 6. SCOPE
z 7. COMPONENT INFORMATION
z 8. MATERIALS OF CONSTRUCTION
z 9 PRODUCT CONTACT MATERIALS, FILTERS AND
ENVIRONMENTAL FILTERS
z 10 OPERATION & MAINTENANCE MANUALS
DISTRIBUTION LIST 13
Typical HVAC IQ Table of
Contents

z 11. LIST OF CERTIFICATES OF CONFORMITY


z 12. SERVICES INFORMATION
z 13. PRE-START CHECKS
z 14. CALIBRATION SCHEDULE
z 15. CONCLUSIONS & APPROVAL
z 16. LIST OF APPENDICES
z 17. REFERENCED DOCUMENTS
z APPENDICES

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Operational Qualification (OQ)
z Formal Record that testing has proved that the
system can operate consistently and reliably
within the Limits set out in the FRS
z Tests need only address the GMP critical
Functions.
z Other non critical functions can be commissioned
and recorded to good engineering standards but do
not need to appear in the OQ

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Typical HVAC OQ Table of
Contents
z 1. SIGNATURE RECORD
z 2. ABBREVIATIONS AND DEFINITIONS
z 3. MODIFICATIONS MADE DURING
QUALIFICATION
z 4. QUALIFICATION INTRODUCTION
z 5. OPERATIONAL QUALIFICATION OBJECTIVE
z 6. SCOPE
z 7. PROCEDURES
z 8. SAFETY
z 9. CALIBRATION

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Typical HVAC OQ Table of
Contents
z 10 OPERATIONAL QUALIFICATION TESTS
10.1 Review of Contractors 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 11. CONCLUSIONS AND APPROVALS
z 12. LIST OF APPENDICES
z 13. REFERENCED DOCUMENTS
z APPENDICES

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Performance Qualification (PQ)
z For Solid Dose HVAC generally replaced by the
ongoing procedures (SOPs) to be used to ensure
that the system stays within acceptance limits
during normal operation and over time.
z 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.
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What Documentation is
Required
z Validation Master Plan (VMP)
z User Requirement Specifications (URS)
z Functional Requirements Specifications (FRS)
z Design / Detailed Specifications (DS)
z Installation Qualifications (IQ)
z Operational Qualifications (OQ)
z Performance Qualifications (PQ)
z Standard Operating Procedures (SOP)
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Thank You for your
Attention