Qualification of Analytical Systems for Regulated and Non-regulated Laboratories 

[Free Webinar: Wednesday, November 21th 2018 – 15:30 CET ] 

So many topics under one single line!

Mark Newton is your expert to listen to when comes to understand compliance at the laboratory

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Presenting: Mark Newton, principal at Heartland QA 

Mr. Newton is an independent consultant with 30+ years of experience in pharmaceuticals as a laboratory scientist, then as a QA professional, supporting LIMS systems, standalone lab instruments, lab informatics and metrics, validation, quality systems, and data standards.  Mark has been deeply involved in data integrity audits and data integrity training to people in QC Laboratories, Manufacturing, and IT.

Mark is also an important contributor at the International Society for Pharmaceutical Engineering.

• Current Chair of the ISPE Global Documents Committee
• Current co-leader of the ISPE/GAMP Data Integrity Special Interest Group
• Co-author for “GAMP Guide: Records and Data Integrity” April 2017
• Co-author of “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification”  Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
• Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems” Nov. 2012

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Outline of the first one-hour webinar course in which Mark will introduce the topics to be developed further in future sessions.

An interesting approach, challenging questions, solid conclusions from a 30 years experienced and well-known expert.

Context of the Instrument Qualification Activity

• Is it Validation, Qualification or Verification?

  • ASTM E2500 definition
  • News flash: Regulators don’t care!

• Benefits of doing the exercise, even for non-regulated labs

  • Question: if I could give a value +/- 25%, is that good enough?
  • Question: if the result might have calculation errors, is that acceptable?
  • Question: is it acceptable to let everyone in the lab change method calculations or configuration without telling anyone?
  • Question: more efficient to design technical controls or do more procedural (human) controls for every test?

The Lab results have a real Direct Impact on product quality! It’s really about Data, not Equipment: Data Lifecycle vs Equipment Lifecycle. Data integrity is not just for GMP activities

• Three questions to answer:
  • What activities will we perform?
  • How extensive does the activity need to be (robust)?
  • How thoroughly do we need to document the activity?
    • Example: Research vs QC Lab

Crafting an Organizational Approach to Analytical Equipment

• Holistic Approach (vs Qualify Equipment/Validate Software)
• Spectrum: USP <1058> and GAMP Lab Guide
• Putting it together: A Continuum of Activities
  • Criteria for the continuum:
    • Data Complexity (overall)
    • Factor: Vendor Dependence
    • Factor: Configurability
    • Factor: Electronic Records; Electronic Signature

Verification Activities and Deliverables

• Using the Continuum to Create a Grid of Activities
• Verification Planning (keep it simple!)
• Requirements: Critical step to get it right
  • Security/network/firewall
  • Access controls by design: some considerations
  • Factors to consider in the requirements phase
    • Access roles/duties (segregation)
    • Data integrity (identify records that need audit trails)
    • Traditional considerations: data inputs, calculations, reports, interfaces, environment
    • Leveling Requirements: User and functional, or one set?
    • Critical requirements (regulatory expectation)
      • Approach to managing requirements for future upgrades
    • Traceability
      • A powerful demonstration of control
    • Design Qualification (joining DQ with Requirements in a Simple Way)
    • Configuration
      • What most do wrong/why the configuration is a challenge
      • Value-added configuration documentation
    • Testing
      • Changes to accommodate holistic approach (IQ/OQ/PQ vs Unit/Integration/System)
    • System Acceptance
      • Normal Process
      • Managing Exceptions (or, how to avoid regulatory entanglements)
    • Operational Phase vs Development Phase

Vendor Management/Selection

• Often neglected, but Important to Success
  • Irrelevant terms, based on experiences: ISO, Market Leader, Long Relationship….
• Involving the Right People (who is needed, and why)
• Multiple Goals: vendor capabilities, data integrity gaps in product
• A wasted exercise when:
  • Does not lead to changes in our validation approach
  • Done too late/after the product is purchased (no influence on price!)

Efficiency in Verification Activities

• Designing Verification for Re-Use/Replication
  • Design protocols for re-use!
  • 90% re-use is better than 0% (Perfect is the enemy of Good)
  • Discuss: a process for multiple configurations
  • Discuss: a process for R&D/Development/GxP use

Mark´s webinar is part of the Academy Webinars Program, an initiative launched by the Paperless Lab Academy to maintain the momentum of the Congress acknowledged as a learning platform.