Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Equipment Qualification
Considerations When Purchasing, Designing,
or Qualifying Storage Units
Robert Craig Miller
Senior ...
Purpose of Today’s Meeting
• Discuss the regulatory requirements driving our processes and the
relationship to test script...
Receipt Storage Distribution
Shipper Qualification Temperature Monitoring Shipper Qualification
Equipment Certification Pr...
Definitions
• Acceptance Criteria – The standards a product or process must meet to
successfully complete a test phase or ...
Definitions (Continued)
• Corrective Action – An action, specified in Standard Operating Procedures, that is
taken in resp...
Definitions (Continued)
• Final Report – A document summarizing the results derived from the execution of a
protocol. The ...
Definitions (Continued)
• Protocol – The written and approved document of an experimental sequence of tests that, when
exe...
So . . . what is Validation?
• Legal responsibility?
• Ethical responsibility?
• Sound Business Practice?
Regulatory Requirements
Validation and Documentation
The FDA’s 1987 guideline defines
validation as:
• Establishing docume...
Key Validation Documents
• Validation Master Plan (VMP)
• User Requirements
• Functional Specifications
• Validation Proto...
User Requirements
• Can you identify your needs
– In writing?
• Musts vs. Wants
• Simple, yet has a large impact on the
de...
Functional Specifications
• The “How To’s” of meeting the User
Requirements
• Other Terms
– User Requirement Specification...
Detailed Design
• The hard specifics of the design
• Detailed specifications and drawings
– Cut sheets
– Technical specs
–...
Design / Validation Relationship
User Requirements PQ
Functional Spec OQ
Detailed Design IQ
Build
Typical Things Done – Summary
Reports
• Completed following protocol execution
– Following completion of each protocol
– M...
GMP Relevance & Risk Assessment
Section
21 CFR
Relevance
Product Equipment Section
21 CFR
Relevance
Product Equipment
Inst...
Re-qualification
• Event Driven
– Replacement of
critical components
– Change in process or
procedures
– Change in personn...
Change Control
• The modification, relocation or
decommissioning of any equipment that
has been tested under validation
co...
Difficulties in Validation
• Inadequate definition of system
requirements / specifications
• Poor protocols
• Inadequate r...
Success in Validation
• Getting Validation personnel involved
early in the process
• Well defined user requirements and
sp...
Discoveries
• What we have learned in our supporting
role to Operations.
– Identifying hot and cold spots.
– Affects of TC...
Typical TC Placement Diagram
TC 01
TC 02
TC 06
TC 04
TC 05
TC 07
TC 08
TC 09
TC 10
TC 11
TC 12
TC 03
TC Shelf Location Sus...
Probe Placement on a Walk-in
FRONT OF UNIT
RTD
8.8'
8.5'
7.4'
Probe 01
Back
Back
Back
Front
Front
Front
Back
Middle
Probe ...
Affects Upon Temperature
During TC Placement
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
0
10
20
30
40
11:42:40
12:20:00
13:0...
All units of same model are created
equal; some operate more efficiently
than others.
-90
-88
-86
-84
-82
-80
-78
-76
-74
...
Cost of Quality
Acceptance Criteria: -195°C to -135°C
Slot Brand X - Economical Brand Y – Top of the Line
1 -88.5°C -178.6...
Quick “Fix”
Acceptance Criteria: -195°C to -135°C
Slot Temperature – High Fill Set Point of 7” Temperature – High Fill Set...
Criticality of Temperature Set Point
Temperature Control Set Point at -85.0C
-90
-88
-86
-84
-82
-80
-78
-76
-74
-72
-70
-...
Affects of Dynamic Testing
-2
-1
0
1
2
3
4
5
6
7
8
9
10
11
11:00:00
12:10:00
13:20:00
14:30:00
15:40:00
16:50:00
18:00:00
...
To Summarize
• As the User, know your requirements and
processes.
• Validation is a lifecycle approach. It’s not a one
and...
OUR PRIMARY OBLIGATION IS
TO THE END USER
• Family
• Friends
• Co-workers
• Strangers
Thank You For Your
Participation
Questions, comments,
complaints?
About the Presenter
Robert “Craig” Miller has over twenty years experience working in the
pharmaceutical and biotech suppo...
Upcoming SlideShare
Loading in …5
×

Equipment Qualification

15,386 views

Published on

A general overview of qualifying storage equipment in a GMP environment

Published in: Education
  • Be the first to comment

Equipment Qualification

  1. 1. Equipment Qualification Considerations When Purchasing, Designing, or Qualifying Storage Units Robert Craig Miller Senior Validation Specialist VaLogic, LLC
  2. 2. Purpose of Today’s Meeting • Discuss the regulatory requirements driving our processes and the relationship to test scripts. • Discoveries encountered in Validations. • Q & A
  3. 3. Receipt Storage Distribution Shipper Qualification Temperature Monitoring Shipper Qualification Equipment Certification Preventive Maintenance Document Control Equipment Qualification Equipment Certification Document Control Change Control Equipment Qualification Document Control Cradle To Grave
  4. 4. Definitions • Acceptance Criteria – The standards a product or process must meet to successfully complete a test phase or to meet delivery requirements. • As-Found-Data – Data comparing the response of an instrument to known standards, as determined without adjustment, after the instrument is made operational. • Calibration: The process of adjusting an instrument or compiling a deviation chart so that its reading can be correlated to the actual value being measured. • Certification – A documented statement, by authorized and qualified individuals, that an equipment/system validation, revalidation, qualification, re-qualification, or calibration has been performed appropriately with acceptable results. • Change Control – A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status.
  5. 5. Definitions (Continued) • Corrective Action – An action, specified in Standard Operating Procedures, that is taken in response to information gathered from environmental monitoring data. This may be implemented when Alert or Action Limits are exceeded or when Trend Analysis indicates a developing problem. • Critical – Of or pertaining to a condition causing an abrupt change in the quality or property of an environment, process or product. • Critical Component – Any component of a critical device that’s failure to perform can be reasonably expected to cause the failure of a critical device, or to affect the device’s safety or effectiveness. • Critical Instrumentation – Those instruments which are pertinent to the proper operation, control, and recording of critical process parameters. • Critical Process Parameter – A control parameter that has a direct relationship to the quality, safety, effectiveness, or performance of the intermediate or final product.
  6. 6. Definitions (Continued) • Final Report – A document summarizing the results derived from the execution of a protocol. The final report shall include a conclusion, which indicates validation success or failure and designates proven acceptable ranges for all critical process parameters as determined by the execution of the validation protocol. • Installation Qualification – The performance of documented verification that an equipment/system installation adheres to approved contract specification and achieves design criteria. • Operational Qualification – The documented verification that the equipment/system performs per design criteria over all defined operating ranges. • Performance Qualification – Documented verification that equipment, systems, or processes operate the way they are purported to do. This operation must be reliable and reproducible within a specified, predetermined set of parameters under normal production conditions and must be in a state of control.
  7. 7. Definitions (Continued) • Protocol – The written and approved document of an experimental sequence of tests that, when executed as prescribed, are intended to produce documented evidence that the equipment or system does what it is designed or claims to do reproducibly. • Qualification – Operation aimed at proving, with regard to materials, equipment, or personnel, that the required conditions are met and that they actually provide the expected results. • Trend Analysis – Periodic review and analysis of environmental monitoring program results that can be related to time, shift, facility, etc. for patterns that may suggest underlying or developing problems. • Validation – The overall term for establishing documented evidence through defined tests and challenges, that a system, manufacturing process, analytical method, and/or piece of equipment meets design criteria and that adequate provisions have been established to keep it in a state of control so it will produce a product that meets predetermined specifications and quality attributes. Validation can be performed prospectively, concurrently, or retrospectively. • Validation Master Plan – The establishment of a dynamic written plan that defines the overall approach to a validation project.
  8. 8. So . . . what is Validation? • Legal responsibility? • Ethical responsibility? • Sound Business Practice?
  9. 9. Regulatory Requirements Validation and Documentation The FDA’s 1987 guideline defines validation as: • Establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
  10. 10. Key Validation Documents • Validation Master Plan (VMP) • User Requirements • Functional Specifications • Validation Protocols • Standard Operating Procedures (SOPs) • Validation Final Reports • Change Control System
  11. 11. User Requirements • Can you identify your needs – In writing? • Musts vs. Wants • Simple, yet has a large impact on the design and validation processes • Provides basis for PQ acceptance criteria
  12. 12. Functional Specifications • The “How To’s” of meeting the User Requirements • Other Terms – User Requirement Specification – Purchasing Specification – Technical Specification • Provides basis for OQ and PQ acceptance criteria
  13. 13. Detailed Design • The hard specifics of the design • Detailed specifications and drawings – Cut sheets – Technical specs – P&ID’s – Manufacturer’s documentation • Provides the basis for IQ
  14. 14. Design / Validation Relationship User Requirements PQ Functional Spec OQ Detailed Design IQ Build
  15. 15. Typical Things Done – Summary Reports • Completed following protocol execution – Following completion of each protocol – May “lump” IQ / OQ together • Content – Defined by Validation Master Plan / SOPs – Clearly states whether equipment met acceptance criteria as stated in the approved protocols – Clearly states user limitations on the equipment, if any – Provides raw data obtained during the studies, along with information regarding performance of the unit during the studies, for example: • How long the unit maintained acceptable temperatures following power loss? • Hot and Cold spots in the unit
  16. 16. GMP Relevance & Risk Assessment Section 21 CFR Relevance Product Equipment Section 21 CFR Relevance Product Equipment Installation Qualification Performance Qualification Purchase Order Verification 211.63 N/A Moderate Operational Qualification Verification 211.22, 211.63, and 211.100 High Low Manufacturer’s. Documentation Verification 211.67, 211.68, and 211.100 N/A Moderate Equipment Set-up and Thermocouple Placement Verification 211.68 and 211.100 Low Low Environmental Conformance Verification 211.63 N/A High Operating Temperature Thermal Mapping 211.63, 211.68, 211.100, and 211.142 High N/A Electrical Utilities Verification Same as above N/A High Thermocouple Calibration Verification 211.68 and 211.100 Low N/A Standard Operating Procedure Verification 211.67, 211.68, 211.100, and 211.142 N/A Moderate Validation Test Equipment Verification 211.68 Low Moderate Operational Qualification Re-qualification Installation Qualification Verification 211.22, 211.63, and 211.100 Low Moderate Preventive Maintenance Verification 211.67, 211.68, and 211.100 Low High Validation Test Equipment Verification 211.68 Low Moderate Critical Instrumentation Calibration/Certification Verification 211.68 and 211.100 High Low Critical Instrumentation Calibration/Certification Verification 211.68 and 211.100 High Low Electrical Utilities Verification 211.63 N/A High Equipment Set-up and Thermocouple Calibration Same as above Moderate N/A Validation Test Equipment Verification 211.68 Moderate N/A Temperature Distribution Thermal Mapping 211.63, 211.68, 211.100, and 211.142 High N/A Equipment Set-up and Thermocouple Calibration 211.68 and 211.100 Moderate N/A Open Door Analysis Thermal Mapping Same as above Moderate N/A Operating Temperature Thermal Mapping 211.63, 211.68, 211.100, and 211.142 High N/A Power Failure Analysis Thermal Mapping Same as above Moderate N/A Thermocouple Calibration Verification 211.68 and 211.100 Moderate N/A Alarms and Controls Testing 211.68, 211.100, Alarms and Controls Testing 211.68, 211.100,
  17. 17. Re-qualification • Event Driven – Replacement of critical components – Change in process or procedures – Change in personnel – Failure Investigation • Time Driven – Change of “the little things” over time – Poorly maintained systems – Routine system failure – Environment dependent
  18. 18. Change Control • The modification, relocation or decommissioning of any equipment that has been tested under validation conditions must be documented. • Change Control is necessary to perpetuate validation • When should Change Control begin? – After the validation report is approved? – Before qualification begins?
  19. 19. Difficulties in Validation • Inadequate definition of system requirements / specifications • Poor protocols • Inadequate resolution / explanation of failures / deviations • Poor planning • Poor communication
  20. 20. Success in Validation • Getting Validation personnel involved early in the process • Well defined user requirements and specifications • Good Communication • Integrating Validation into design-build- test-use cycle
  21. 21. Discoveries • What we have learned in our supporting role to Operations. – Identifying hot and cold spots. – Affects of TC placement on loaded upright, ultra-low storage unit. – Same is often different. – Hidden costs of being economical. – Helping is sometimes hurting. – When up is down and when down is up.
  22. 22. Typical TC Placement Diagram TC 01 TC 02 TC 06 TC 04 TC 05 TC 07 TC 08 TC 09 TC 10 TC 11 TC 12 TC 03 TC Shelf Location Suspension 01 Top Back Left Liquid 02 Top Front Right Airborne 03 Second Front Left Airborne 04 Second Controller Airborne 05 Third Back Left Airborne 06 Third Center Airborne 07 Third Front Right Airborne 08 Fourth Front Left Airborne 09 Fourth Back Right Airborne 10 Bottom Center Liquid 11 Bottom Front Right Airborne 12 External Filter Airborne
  23. 23. Probe Placement on a Walk-in FRONT OF UNIT RTD 8.8' 8.5' 7.4' Probe 01 Back Back Back Front Front Front Back Middle Probe 02 Front Probe 03 Middle Probe 04 Probe 05 Probe 11 Probe 06 Probe 07 Probe 09 Probe 10 HighLevel 6' fromfloor MidLevel 4' fromfloor LowLevel 2' fromfloor Middle Probe 08 Middle Probe 12
  24. 24. Affects Upon Temperature During TC Placement -100 -90 -80 -70 -60 -50 -40 -30 -20 -10 0 10 20 30 40 11:42:40 12:20:00 13:00:00 13:40:00 14:20:00 15:00:00 15:40:00 16:20:00 17:00:00 17:40:00 18:20:00 19:00:00 19:40:00 20:20:00 21:00:00 21:40:00 22:20:00 23:00:00 23:40:00 0:20:00 1:00:00 1:40:00 2:20:00 3:00:00 3:40:00 4:20:00 5:00:00 5:40:00 6:20:00 7:00:00 7:40:00 8:20:00 9:00:00 9:40:00 10:20:00 11:00:00 11:40:00 Time Temperature 201A-T13 202A-T14 203A-T15 204A-T16 205A-T17 206A-T18 207A-T19 208A-T20 209A-T21 210A-T22 211A-T23 Ambient TC placement Temperatures below -70C Undocumented entry by Operations -100 -90 -80 -70 -60 -50 -40 -30 -20 -10 0 10 20 30 40 11:42:40 12:20:00 13:00:00 13:40:00 14:20:00 15:00:00 15:40:00 16:20:00 17:00:00 17:40:00 18:20:00 19:00:00 19:40:00 20:20:00 21:00:00 21:40:00 22:20:00 23:00:00 23:40:00 0:20:00 1:00:00 1:40:00 2:20:00 3:00:00 3:40:00 4:20:00 5:00:00 5:40:00 6:20:00 7:00:00 7:40:00 8:20:00 9:00:00 9:40:00 10:20:00 11:00:00 11:40:00 Time Temperature 101A-T01 102A-T02 103A-T03 104A-T04 105A-T05 106A-T06 107A-T07 108A-T08 109A-T09 110A-T10 111A-T11 Ambient TC placement Temperatures below -70C • Same model; same set point; same TC diagram. • Different load; different age; different ambient. • Recovery time: 8 hours and 16 hours, respectively.
  25. 25. All units of same model are created equal; some operate more efficiently than others. -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 12:16:05 12:55:00 13:35:00 14:15:00 14:55:00 15:35:00 16:15:00 16:55:00 17:35:00 18:15:00 18:55:00 19:35:00 20:15:00 20:55:00 21:35:00 22:15:00 22:55:00 23:35:00 0:15:00 0:55:00 1:35:00 2:15:00 2:55:00 3:35:00 4:15:00 4:55:00 5:35:00 6:15:00 6:55:00 7:35:00 8:15:00 8:55:00 9:35:00 10:15:00 10:55:00 11:35:00 12:15:00 Time Temp TC 01 TC 02 TC 03 TC 04 TC 05 TC 06 TC 07 TC 08 TC 09 TC 10 TC 11 -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 12:16:05 12:55:00 13:35:00 14:15:00 14:55:00 15:35:00 16:15:00 16:55:00 17:35:00 18:15:00 18:55:00 19:35:00 20:15:00 20:55:00 21:35:00 22:15:00 22:55:00 23:35:00 0:15:00 0:55:00 1:35:00 2:15:00 2:55:00 3:35:00 4:15:00 4:55:00 5:35:00 6:15:00 6:55:00 7:35:00 8:15:00 8:55:00 9:35:00 10:15:00 10:55:00 11:35:00 12:15:00 Time Temp TC 01 TC 02 TC 03 TC 04 TC 05 TC 06 TC 07 TC 08 TC 09 TC 10 TC 11 -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 12:16:05 12:55:00 13:35:00 14:15:00 14:55:00 15:35:00 16:15:00 16:55:00 17:35:00 18:15:00 18:55:00 19:35:00 20:15:00 20:55:00 21:35:00 22:15:00 22:55:00 23:35:00 0:15:00 0:55:00 1:35:00 2:15:00 2:55:00 3:35:00 4:15:00 4:55:00 5:35:00 6:15:00 6:55:00 7:35:00 8:15:00 8:55:00 9:35:00 10:15:00 10:55:00 11:35:00 12:15:00 Time Temp TC 01 TC 02 TC 03 TC 04 TC 05 TC 06 TC 07 TC 08 TC 09 TC 10 TC 11 -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 14:56:15 15:30:00 16:05:00 16:40:00 17:15:00 17:50:00 18:25:00 19:00:00 19:35:00 20:10:00 20:45:00 21:20:00 21:55:00 22:30:00 23:05:00 23:40:00 0:15:00 0:50:00 1:25:00 2:00:00 2:35:00 3:10:00 3:45:00 4:20:00 4:55:00 5:30:00 6:05:00 6:40:00 7:15:00 7:50:00 8:25:00 9:00:00 9:35:00 10:10:00 10:45:00 11:20:00 Time Temp TC 01 TC 02 TC 03 TC 04 TC 05 TC 06 TC 07 TC 08 TC 09 TC 10 TC 11
  26. 26. Cost of Quality Acceptance Criteria: -195°C to -135°C Slot Brand X - Economical Brand Y – Top of the Line 1 -88.5°C -178.6°C 2 -94.5°C -182.1°C 3 -118.3°C -186.4°C 4 -127.0°C -187.8°C 5 -154.9°C -188.8°C 6 -159.5°C -189.8°C 7 -171.1°C -190.9°C 8 -187.9°C -192.2°C 9 -192.2°C -192.6°C 10 -194.6°C -192.8°C 11 -194.8°C -193.5°C 12 -196.5°C -194.1°C 13 -196.6°C -194.3°C
  27. 27. Quick “Fix” Acceptance Criteria: -195°C to -135°C Slot Temperature – High Fill Set Point of 7” Temperature – High Fill Set Point of 10” 1 -88.5°C -125.3°C 2 -94.5°C -134.7°C 3 -118.3°C -139.3°C 4 -127.0°C -149.2°C 5 -154.9°C -153.4°C 6 -159.5°C -160.9°C 7 -171.1°C -167.5°C 8 -187.9°C -184.3°C 9 -192.2°C -192.1°C 10 -194.6°C -196.8°C 11 -194.8°C -196.9°C 12 -196.5°C -196.9°C 13 -196.6°C -197.1°C
  28. 28. Criticality of Temperature Set Point Temperature Control Set Point at -85.0C -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 -64 -62 -60 12:50:00 12:55:00 13:00:00 13:05:00 13:10:00 13:15:00 13:20:00 13:25:00 13:30:00 13:35:00 13:40:00 13:45:00 13:50:00 13:55:00 14:00:00 14:05:00 14:10:00 14:15:00 14:20:00 14:25:00 14:30:00 14:35:00 14:40:00 14:45:00 14:50:00 14:55:00 15:00:00 15:05:00 15:10:00 15:15:00 Time Temperature(DegC) Min Max Avg Temperature Control Set Point at -80.0C -90 -88 -86 -84 -82 -80 -78 -76 -74 -72 -70 -68 -66 -64 -62 -60 12:50:00 12:55:00 13:00:00 13:05:00 13:10:00 13:15:00 13:20:00 13:25:00 13:30:00 13:35:00 13:40:00 13:45:00 13:50:00 13:55:00 14:00:00 14:05:00 14:10:00 14:15:00 14:20:00 14:25:00 14:30:00 14:35:00 14:40:00 14:45:00 14:50:00 14:55:00 15:00:00 15:05:00 15:10:00 15:15:00 Time Temperature(DegC) Min Max Avg
  29. 29. Affects of Dynamic Testing -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 11:00:00 12:10:00 13:20:00 14:30:00 15:40:00 16:50:00 18:00:00 19:10:00 20:20:00 21:30:00 22:40:00 23:50:00 01:00:00 02:10:00 03:20:00 04:30:00 05:40:00 06:50:00 08:00:00 09:10:00 10:20:00 11:30:00 12:40:00 13:50:00 15:00:00 16:10:00 17:20:00 18:30:00 19:40:00 20:50:00 22:00:00 23:10:00 00:20:00 01:30:00 02:40:00 03:50:00 05:00:00 06:10:00 07:20:00 08:30:00 09:40:00 10:50:00 Time Temperature(DegC) B090 B131 B135 B145 B277 B353 B354 B403 D002 D003 D685 D686 D687 D691 D692 D693 D694 D695 D697 D698 D699 D700 D701 D703 D704 D705 D706 D707 D709 D710 D711 D712 D713 D714 D721 D722 Open Door Test #1 Open Door Test #2 Open Door Test #3
  30. 30. To Summarize • As the User, know your requirements and processes. • Validation is a lifecycle approach. It’s not a one and done. • Be cognizant of change control. • Have a thorough TC/logger placement diagram to detect hot and cold spots. • Understand the functionality of the units being qualified. • But, above all, the most import thing to remember is that . . .
  31. 31. OUR PRIMARY OBLIGATION IS TO THE END USER • Family • Friends • Co-workers • Strangers
  32. 32. Thank You For Your Participation Questions, comments, complaints?
  33. 33. About the Presenter Robert “Craig” Miller has over twenty years experience working in the pharmaceutical and biotech support industry. Starting off as a Repository Technician at the National Cancer Institute Clinical Repository, he has held increasing key positions and recently left Fisher BioServices (formerly McKesson BioServices, Ogden BioServices) after ten years as the Validation Manager to join VaLogic, LLC, a calibration and validation consulting firm supporting life sciences. Contact Information: Email: cmiller@valogic.us Office: 240-529-1673 Cell: 240-602-1424 Fax: 240-529-1678 Web: www.valogic.us

×