Reduced Testing and Reduced Sampling in Analytical Laboratories (1 day or 2 days)

1. Introduction (30 minutes)

  • Short intro to ECA and speaker
  • Brief overview of the agenda

2. Incoming Good Testing, General Part (60-90 minutes)

  • US and European requirements focusing on QC
  • Responsibilities for incoming goods (sampling, testing, releasing)
  • SOP, specification documents, procedures
  • LIMS documents and raw data management
  • Role of raw material lab within the pharmaceutical supply chain
  • Efficient organisation
  • Questions / discussion

3. Sampling and Testing Procedures for APIs and Excipients (60-75 minutes)

  • Regulatory requirements (EU, FDA, Guidelines)
  • Reduced testing / skip lot testing approaches
  • Sampling plans (case study)
  • Certification vs. testing (supplier quality driven approach)
  • Supplier qualification and risk analysis as important rational for sampling approach
  • Sampling documentation (sampling procedure, record, necessary information, etc.)
  • Examples for documentation approach
  • Questions / discussion

4. Sampling and Inspection Procedures for Packaging Material (60-75 minutes)

  • Regulatory and pharmacopeial requirements (EU, FDA, Guidelines, Ph.Eur / USP)
  • Common practice (AQL testing, defect evaluation list)
  • Reduced testing / skip lot testing approaches
  • Sampling plans acc. ISO2859 and defect evaluation lists (case study)
  • Supplier sampling vs. inhouse sampling
  • Supplier qualification and risk analysis as important rational for sampling approach
  • Sampling documentation (sampling procedure, record, necessary information, etc.)
  • Questions / discussion

5. Test Procedures and Methods for Incoming Good Testing (45-60 minutes)

  • Pharmacopoeia methods vs. in-house methods
  • Harmonisation vs. multi-compendial testing (proof equivalence, case study testing strategy)
  • Full validation of pharmacopoeia test (ICH Q2/Q14, USP<1225>)
  • Verification of methods (EP-approach, USP-chapter <1226>, case study)
  • What to do with excipients not specified in Pharmacopeia
  • Reference standards (qualification, traceability)
  • Questions / discussion

6. Spectroscopic Raw Material Identification (30 minutes)

  • NIR, IR-ATR Raman approach
  • Single container identification
  • Advantages / disadvantages of approaches
  • Costs / benefits
  • Relevant monographs
  • Questions / discussion

7. Design and Qualification of Sampling Chambers (45-60 minutes)

  • Who has to perform the sampling (QC vs. logistic/production)
  • Sampling area
  • Clean room classes
  • Requirements, what are the environmental requirements
  • Initial qualification (DQ-IQ-OQ-PQ)
  • Monitoring programs (e.g. microbio and particle)
  • Maintenance and preventive activities (e.g. cleaning, disinfection)
  • Training program for sampling staff
  • Discussion of pallet changing for sampling
  • Discussion of sampling utilities
  • Questions / discussion

8. Out of Specification Results (30-45 minutes)

  • Regulatory requirements (FDA guide)
  • Phase I, lab investigation
  • Phase II, further investigation
  • Full scale investigation (deviation)
  • Retesting programs
  • Examples from form 483
  • OOS vs. OOT vs. adverse results
  • OOS trending program
  • Questions / discussion

9. Final Wrap Up, Discussions and Closing of Event (30 minutes)

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