Validation – Qualification – Testing
- Qualification of Cleanrooms, Laminar Airflow Cabinets (LAF) according to ISO 14644
- Testing of HEPA/ULPA filters according to EN 1822 and ISO 29463.
- Qualification of thermal process equipment: autoclaves, sterilisers, depyrogenisation cabinets, laboratory stability and climate chambers, medical refrigerators/freezers, sample storage cryo/ultra freezers
- Qualification of compressed gas systems
- Testing/qualification of laboratory equipment
- Ambient temperature/humidity monitoring of pharmaceutical storage rooms
- Testing of trucks for transporting medical goods
- Validation of computer systems against GMP, GAMP5 requirements
- Risk analysis (FMEA)
- Conducting internal audits based on GMP, quality system requirements
- Other GMP services: preparation of SOPs, VMPs, validation and other GMP documents
- Advice on cleanroom design in accordance with GMP and ISO 14644 requirements
- Various GMP training courses
