A Summary of the PreConference Survey Results and Setting A Common Terminology for the Workshop

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A Summary of the Pre-Conference Survey Results
and Setting A Common Terminology for the Workshop

• Marta Hamilton, Ph.D.
• Director, Biopharmaceutics
• OSI Pharmaceuticals, Inc
• Boulder, CO, USA

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AAPS Analytical Instrument Validation Workshop

• Workshop Survey Full Results
• 184 responses
• 18 December 2002

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Your professional responsibility
59.2
Lab Management/Administration
20.1
Lab Analyst (User)
11.4
Regulatory / Quality Assurance
3.8
Consultant
5.4
Instrument Validation Specialist
3.8
Consultant
5.4
Instrument Validation Specialist
11.4
Regulatory / Quality Assurance
20.1
Lab Analyst (User)
59.2
Lab Mgtmt./Administration
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What is the most time-consuming part during
validation of analytical instruments? (Check all
that apply)
43.5 Completing Forms/Reports
39.7 Review/Approve Data Reports
34.2 Perform Tests/Collect Data
21.2
Waiting in queue
33.7 Consensus Building
21.2 Waiting in queue
33.7
Consensus Building
34.2
Perform Tests/Collect Data
39.7
Review/Approve Data Reports
43.5
Completing Forms/Reports
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Who is best qualified to perform instrument
validation (not who is performing the validation)
that would provide a scientific value?
33.7
Lab. Analysts (Users)
29.8
Separate Valid Group in Co.
15.5
Manufacturer
7.2
13.8
User's Dept, not user
Outside consultant
7.2
Outside consultant
13.8
User's Dept, not user
15.5
Manufacturer
29.8
Separate Valid Group in Co.
33.7
Lab. Analysts (Users)
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What is an appropriate time for completion of a
typical analytical instrument validation?
62.1
62.1
Under 1 month
30.8
1-3 months
6.0
3-6 months
1.1
Over 6 months
30.8
6.0
1.1
Under 1 month
1-3 months
3-6 months
Over 6 months
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Key Messages From Survey

• Current instrument validation procedures are
  primarily to cover regulatory need (57.1).
• Process should take ? 3 mo (92.9), preferably lt1
  mo (62.1).
• Streamlined procedures exist in some labs (56.8)
  but do not return benefit proportional to efforts
  taken (52.7).
• The instrument validation process should be more
  scientifically justified (56.0).

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Key Messages From Survey

• Analytical instrument validation should be more
  like analytical/bioanalytical method validation
  with a defined study (78.6) that examines
  scientifically justified essential parameters
  that are specific to the instrument type and
  application (80.2).
• After validation, the instrument can be kept fit
  for use though calibration and /or performance
  checks and maintenance (73.5). The validation
  report could give guidance as to what should be
  done (65.4).

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• Setting a Common
• (and Appropriate) Terminology

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PQ
DQ/IQ/OQ/PQ
Retrospective
Phase model
Raw Data
Open system
Change control
Prospective
DQ
Closed system
Calibrate
What Does It All Mean?What do we actually do?
Compliant system
White Box Testing
IQ
OQ
Test plan
Validation plan
Life cycle
Verify
Qualify
Validate
Retrospective
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Validate? Verify? Qualify?
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Calibration - is this really truly done?
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DQ? IQ? OQ? PQ?
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Does an Analytical Instrument Have a Life Cycle?
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Terminology adapted from other applications
(process, software, medical device validations)
are often cumbersome and ill-fitting
? confusion, miscommunication, misrepresentation
of goals
NEED FOR APPROPRIATE AND SIMPLE TERMINOLOGY!!!
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Break-out Session
Defining Analytical Instrument Validation and
Setting a Common Terminology