01
Qualification
DQ, IQ, OQ and PQ for cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment. We derive the test scope from the risk assessment.
Industry
GMP laboratories
GMP laboratories produce the data on which release decisions are based. Besides the analytical instruments, rooms, ventilation and utilities must also be demonstrably fit for purpose.
Focus
Typical topics in gmp laboratories.
01
Laboratory areas
Qualification of laboratory rooms including ventilation, pressure regimes and ambient conditions.
02
Technical infrastructure
Utilities, fume hoods, refrigerators and climatic chambers with GMP relevance, including temperature mapping.
03
Documentation and SOPs
Equipment-related SOPs, test plans and qualification documents that fit everyday laboratory work.
04
Refurbishment during operation
Plan change control and requalification so that the laboratory can keep working.
Services
Relevant services.
02
GMP documentation
Qualification master plan, risk assessment, URS, room book, test plans and SOPs. Every requirement can be traced to its evidence.
Additional
Calibration & measurement
Calibration of quality-relevant instruments and sensors for temperature, humidity, differential pressure and air velocity, mobile or permanently installed.
Other industries
Contact
Tell us briefly about your project.
You will get a personal reply with a first assessment: what scope makes sense, how we would approach it and which documents you will need.