GMP Requirements to Quality Control Laboratories

  Content Day 1
09.00 - 09.45 Regulatory Requirements for Quality Control and Inspection Topics EU
  • EU (GMP-Guidelines, Chapter 6), USA (CFR), PIC(S)(Aide memoires)
  • FDA 483s and Warning Letters, key issues in inspections
09.45 - 10.30 Qualification of Analytical Instruments and Data Integrity
  • Legal requirements (cGMP, CFR, etc.)
  • USP General Chapter <1058> Analytical Instrument Qualification, analytical instrument life-cycle
  • Qualification phases (DQ/IQ/OQ/PQ)
  • Data integrity
  • Examples
10.30 - 11.00 Break
11.00 - 11.30 System Suitability Tests
  • Chromatography (USP <621>, Ph.Eur. 2.2.46)
11.30 - 12.30 Validation of Analytical Procedures
  • Regulatory requirements (ICH, FDA, compendia)
  • Lifecycle approach (3-Stage-Model according to draft USP General Chapter <1220>)
  • Validation characteristics
  • Verification of compendial procedures
  • Rational design of validation studies, identification of relevant performance parameters, Sensible use of statistics
12.30 - 14.00 Break
14.00 - 16.00 Workshop: Avoiding Mistakes in Analytical Validation
  • Learning form mistakes, evaluation of validation results from publications
  • Identification of erroneous and correct approaches
16.00 - 16.30 Break
16.30 - 17.30 Transfer of Analytical Procedures
  • Regulatory requirements and guidelines (ISPE, WHO, USP)
  • USP-Draft <1220> Analytical procedure life cycle 
  • Analytical transfer process, types of transfer (transfer strategy), documentation, design and evaluation of results (simple & statistical comparison) 
  • Acceptance criteria, deviations, failures, suspect & OOS results, causes of problems during transfer
17.30 Final Discussion
  Content Day 2
09.00 - 10.00 Reference Standards and Laboratory Reagents
  • Regulatory requirements
  • Types of reference standards (compendial, primary, secondary)
  • Traceability, characterisation, and retest date
  • Key issues, risk-based approach for management
  • Storage and shelf-life of laboratory reagents and solutions, stability investigation of solutions for quantitation
10.00 - 10.30 Break
10.30 - 11.15 Stability Investigations
  • Regulatory requirements for stability testing of drug substances and drug products
  • Types of stability studies, storage conditions requirements according to climatic zones
  • Stability protocol and report, establishment of storage conditions and shelf-life
  • Stability testing for post-approval changes
11.15 - 12.15 Investigating Out-of Specification (OOS) Test Results
  • Requirements of the FDA Guidance, efficient laboratory investigations, importance of clear terminology (reanalysing, retesting, resampling)
  • Variability-caused OOS results, investigation of atypical results, proactive strategies to prevent OOS results
12.15 - 13.45 Break
13.45 - 15.45 Workshop: Investigating Out-of Specification (OOS) Test Results
  • Discussion and evaluation of example OOS investigations in groups
15.45 - 16.15 Break
16.15 - 17.00 Normal or not-normal?
  • Identification of suspect results and trends (out-of-trend - OOT, out-of-expectation - OOE)
  • Estimation of the "true" variability
  • Establishment of warning limits for product and method, quality control charts
17.00 Final Discussion

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