Qualification & validation strategies

We develop customized qualification and validation concepts on your behalf, in accordance with current quality standards and your company-specific guidelines.

Preparation of GMP documents

  • Master plans
  • Risk analysis
  • DQ regulations/plans and reports
  • IQ regulations/plans and reports
  • OQ regulations/plans and reports
  • Process validation documentation
  • Transfer protocols

Documentation can also be provided in English.

Qualification of plant and equipment

By qualification we mean providing documentary evidence that plant and equipment meet the requirements within defined limits - the acceptance criteria.

  • Sterilization installations (autoclaves, hot air sterilizers, etc.)
  • Temperature controlled systems (+65°C to -196°C for equipment, premises and storage warehouses)
  • Clean rooms
  • LF workbenches (MSW) and areas
  • Washing machines
  • Lyophilisators
  • Monitoring systems
  • Chromatography plants
  • Laboratory equipment
  • Processing plants
  • Critical media supply systems
  • Pharmaceutical water, clean steam, process air, process gases and CIP systems

Clean room qualification

We qualify rooms and laminar flow workbenches according to the requirements of Annex 1 of the GMP code of practice, EN ISO 14644 and customer demands. This involves the following measurements:

  • Measuring particle concentration at rest and during operation
  • Determining ventilation rates for turbulent mixed airflow / measuring flow speeds for low turbulent uni-directional airflow
  • Measuring the differential pressure between rooms and their surroundings
  • Measuring room recovery rates
  • Leakage detection for installed HEPA filters (filter integrity)
  • Measuring flow speeds for low turbulent uni-directional airflow (laminar flow)
  • Measuring room temperatures / relative humidity
  • Airflow visualization

Process validation:

Sterilization validation

We undertake thermal validations of autoclaves and process plants (SIP = Sterilization in Place) in accordance with the latest requirements. The evaluation of bio indicators is undertaken by partner laboratories. With our extensive experience and facilities for recording up to 108 temperatures simultaneously, we are also able to undertake large projects.

Cleaning validation

We have many years’ experience in helping to develop and validate cleaning processes (CIP = Cleaning in Place) for washing machines and process plants. Microbiological and chemical analysis is undertaken by partner laboratories where required.

Process validation for pharmaceutical manufacturing processes

Process validation provides documentary evidence that a process results in the manufacture of a product in an effective and reproducible manner, within particular parameters and meeting pre-determined specifications and quality attributes.

  • Cell and viral banks
  • Up and downstreaming
  • Puffer and media preparations

Transport validation

Lifecycle validation