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Qualification and Validation (IQ, OQ, PQ) of Laboratory Instruments
and
Systems with a Risk Based Strategy for QS Compliance
Abstract:

This training gives a conceptual background of the qualification and validation of various instruments, apparatus, devices, systems and
equipment from a risk assessment and product lifecycle perspective with several examples, specifications, protocols and SOP requirements at
various stages of deployment and use of various equipment, instruments, etc.  It scopes out the requirements testing and acceptance criteria to
calibrate, standardize or validate as appropriate various laboratory equipment/plant/process equipment/devices/gadgets/recorders/on-line
monitors/meters/micro devices (e.g. HPLC, GC, MS, Dissolution apparatus/blenders/mixers/stability chambers/auto-claves or common
Instruments, meters and devices) in plant, production micro labs, aseptic areas and processing departments throughout various functions in the
cGMP facilities.  Examples are discussed with acceptance criteria, particularly with lab systems and their QC/QA perspectives.  The regulatory
aspects and global guidelines will be discussed with documentation strategies, including PVP, validation protocols, SOP’s, charts, forms, data
sheets, etc., with global guidelines discussions from a risk assessment (ICH Q9, ASTM, ISO) approach.



Course Outline:

  • Introduction/Quality Systems
  • Regulatory Requirements and FDA Directives
  • ICH Q7,Q2(R1) and other Guidelines
  • Measurement Resolution and Errors
  • Calibration Standardization and Validation
  • Product Lifecycle Concept
  • Responsibilities of Vendors and Users
  • IQ/OQ/PQ and PM
  • Validation and Qualification Strategies; Risk Assessment Approach
  • ICH Q9
  • Documentation Strategies; Master Validation Plan and Protocols
  • Examples of OQ and PQ
  • HPLC Systems
  • Dissolution Apparatus
  • TOC, LC-MS and others
  • PQ vs. System Suitability
  • Training Requirements
  • Recent Harmonization Efforts
  • References and Conclusions