GMP Requirements to Quality Control Laboratories

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

Please note that we need about 3 months preparation for the organisation of your in-house training course.

  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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK