Beruflich Dokumente
Kultur Dokumente
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
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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
4
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
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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
14
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