Qualification and Validation

Qualification and validation is the core of GMP and there are the following chapters on it in the GMP Compliance Adviser:

  • Qualification (Official requirements and agency expectations, Activities for the preparation of a qualification, Qualification documentation, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Qualification by third party, The qualification life cycle, Example SOP for the qualification of equipment)
  • Process Validation (Official requirements and agency expectations, Validation – a key element in a QM system, Organisation, planning and implementation, Validation documentation),
  • Cleaning Validation (Official requirements and agency expectations, How to validate cleaning procedures, Cleaning validation master plan, Establishing the scope of validation, Establishment of limits, Sampling procedures, Analytical procedures, Documentation, Maintenance of the validated status, Cleaning validation documentation (example),
  • Computer System Validation (Introduction and terminology, Regulatory requirements for computerised systems and the validation process, System life cycle, System classification and risk management, Validation of computerised systems, Operation of computerised systems , External service providers, Validation of Excel applications) and the
  • Regulatory requirements in Guidelines of EU, ICH, PIC/S, WHO
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