Analytical Instrument Qualification in GLP and GMP Environments

1
Analytical Instrument Qualification in GLP and
GMP Environments

• Report from Breakout Session B
• 3 March 03

2
GLP Vrs GMPDifferences

• Batch documentation - MBR specific to GMP
• GMP criteria generally viewed as tighter than GLP
• Differences focussed on what is done with a
  validated instrument
• documentation generated
• processes/procedures

3
GLP Vrs GMPDifferences (continued)

• GLP includes inherent quality/performance checks
  through standards and QCs
• No Out-of-Specification (OOS) in GLP - impact on
  validation?
• How failure of a system component is addressed

4
GLP Vrs GMPSimilarities

• Core validation similar for both applications
• Issues as they apply to AIQ are the same for GLP
  and GMP
• Focus on instrument performance NOT on method
  performance
• System suitability / fitness-for-use testing

5
Classifications

• Instrument Vrs Equipment AIQ in GMP or GLP
• Different approach to a mixer/shaker compared to
  a HPLC
• Validation/Qualification levels or differences
  between several (2 to 3) instrument/equipment
  classes
• Concern this could become too complicated

6
Concerns

• QA community need to respect differences in GLP
  vrs GMP
• cases of GMP needs being imposed on GLP
• Will a white paper force the GLP community
  closer to GMP processes?

7
Opportunities

• Software to be considered and treated as integral
  part of instrument
• Holistic instrument validation
• Clarify user/vendor responsibilities
• A common core validation is possible based on
  good science
• application requires GMP and GLP
  documentation/action specifics

8
Questions

• ?????????