Lifecycle Management in Pharmaceutical Analysis (2 days)

  Content Day 1
09.00 - 09.45 The Three Stages of Analytical Lifecycle Management
  • Overview on EFPIA/PhRMA Paper and the draft USP Chapter <1220>
  • Alignment with manufacturing process
  • Analytical Target Profile  (ATP), continual improvement and regulatory flexibility
  • ICH Q12, Q2(revision), Q14 
09.45 - 10.30 Performance Characteristics: Accuracy and Precision
  • Error types (random and systematic), point estimate or statistical evaluation, combined or separate evaluation of accuracy and precision
  • Total analytical error, target measurement uncertainty, derivation of acceptable precision based on probability distributions
10.30 - 11.00 Break
11.00 - 11.45 Workshop: Understanding Variability (Statistical Simulations)
  • Scatter of standard deviations and single results and its consequences (OOS frequencies)
11.45 - 12.30 Analytical Target Profile (ATP)
  • Derivation of requirements from the respective Critical Quality Attribute
  • Method independence, ATP-types 
  • Compendial Examples, BP/MHRA Case Study
12.30 - 13.30 Break
13.30 - 14.15 Workshop: Establishing an ATP for Example Critical Quality Attributes
  • e g. for identification of drug substance, of active in finished product, of polymorphic form, content of drug substance, of active in finished product, of impurities, bioassay, water determination, residual solvents
14.15 - 15.00 Stage 1: Method Design
  • Method understanding, method selection, risk assessment
  • Robustness investigations
  • Design of experiments, identification of experimental parameters, establishment of the Method Operable Design Region (MODR)
  • Analytical Method Control Strategy, knowledge management, “Translation” of ATP into specific method requirements 
15.00 - 15.30 Break
15.30 - 16.00 Workshop Method Selection
  • To (likely) meet the requirements of the example ATP(s)
16.00 - 17.30 Workshop: Risk Assessment 
  • Use of fishbone diagrams, identification of controllable factors, noise factors and experimental parameters (CNX)
  • Use of priority matrix and failure mode and effects analysis (FMEA) for the example method(s)
17.30 Final discussion
  Content Day 2
09.00 - 09.45 Analytical Control Strategy
  • Identification of control needs from risk assessment, system suitability tests, compendial requirements
  • "Non-numerical" controls, derivation of acceptance criteria for system suitability tests
09.45 - 10.15 Workshop: Analytical Control Strategy
  • Development of a control strategy for the example method(s)
10.15 - 10.45 Break
10.45 - 11.45 Stage 2: Method Performance Qualification
  • Experimental confirmation of performance or reference to stage 1 investigations (ICHQ2, Q14)? 
  • Precision of the reportable value, precision study for the definition of a science-based replication strategy, averaging
11.45 - 12.15 Workshop: Replication Level
  • Optimisation of the number of injections/measurements, sample preparations, and series/runs for LC-content and bioassay
12.15 - 13.15 Break
13.15 - 13.45 Workshop: Use of Data from Method Development
  • Prerequisites and documentation, selection for example method(s)
13.45 - 14.45 Stage 3: Continued Method Performance Verification
  • Ensuring the required performance for each application and after changes
  • Routine monitoring of performance and evaluation, suitable parameters, continual improvements
14.45 - 15.15 Break
15.15 - 15.45 Workshop Routine Monitoring
  • Selection of suitable performance parameters, evaluation of example data sets, selection of appropriate control charts
15.45 - 16.30 Workshop: Change Management
  • Evaluation of impact of changes, adjustment vs. changes, risk assessment, definition of appropriate actions, for example method(s)
16.30 Final Discussion

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