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
Pharma
In the manufacture of medicinal products, product quality depends directly on the technical infrastructure. Authorities inspect against the EU GMP Guide, and for the US market 21 CFR Part 211 applies as well. Accordingly, qualification and documentation are examined closely in inspections and customer audits.
Focus
Typical topics in pharma.
01
Cleanrooms and HVAC
Qualification of cleanroom areas of grades A to D and the associated HVAC systems, from the pressure cascade to particle classification to ISO 14644-1.
02
Pharmaceutical water and utilities
Purified Water and WFI to Ph. Eur., compressed air and technical gases with product contact.
03
Annex 1 and contamination control
Placing technical systems within the Contamination Control Strategy and gap analyses against the revised Annex 1.
04
Storage areas and cold rooms
Temperature and humidity mapping of warehouses, cold rooms and climatic chambers as evidence of suitable storage conditions under EU GMP and GDP.
05
New builds and refurbishments
Plan qualification from the start. That saves rework at the end of the project.
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.
03
GMP consulting
Joining running projects, Annex 1 gap analyses and audit preparation. At the end you know where you stand and what to do next.
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.