Niels Kristoffersen, owner of Valitech Aps, has more than 25 years experience in the pharmaceutical industry and has been employed by Novo Nordisk A/S and Novo Nordisk Engineering A/S (NNE) with implementation of processes and equipment in cGMP projects.
Valitech can assist with qualification of equipment and process facilities in all stages of your project. Preparation of protocols and test plans according to ISPE baseline - Pharmaceutical Guide Series and GAMP "Validation of Automated Systems".
- Validation plans
Preparation of Validation and Validation Master plans
- Impact and Quality Risk Assessments
PFMEA / FMEA and Quality Risk Management in accordance with ICH Q9.
- User Requirements Specifications (URS)
Preparation of User Requirements Specifications for Specific Equipment Based on Risk Assessments
- Qualification (DQ, IQ, OQ, PQ)
Preparation and execution of Design Qualification, Installation Operation and Performance Qualification Protocols and Test Plans
- Preparation of SOPs
- Utility systems (PW / WFI / CS)
Intensive knowledge of utility systems for water and clean-steam systems
- Stand-alone equipment, eg. aseptic filling machines, autoclaves, washing machines, dry sterilizers, climate rooms and refrigerators / freezers.
A small selection of completed projects with our customers ...
- Oral Launch Plant -
Preparation of risk assessment, specifications (URS), supplier contact, DQ, FAT / SAT, Installation and commissioning, IQ / OQ of washing machine for tablet production (OSD).
Work package owner for wash and sterilization.
Preparation of risk assessment, specifications (URS), supplier contact, DQ on 2 washing machines and 1 GMP autoclave and 1 kill autoclave.
- OPF3 projekt -
Preparation of risk assessment, specifications (URS), supplier contact, DQ, FAT / SAT, Installation and commissioning, IQ / OQ of washing machine for tablet production (OSD).
- Air-gap projekt -
Micro dosing of silicone in primary glass containers (cartridges) for injectables.
Quality by Design project including Design of Experiments (DoE).