consultancy services

Valitech have been working with cGMP projects for several companies in the pharmaceutical industry, since the beginning of 2007.

Valitech offers more than 25 years of experience in GMP.


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".

Competences that include, among others.

 

- 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.

COMPLETED PROJECTS

A small selection of completed projects with our customers ...

New tablet factury in Måløv - Novo Nordisk A/S

- 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).

Green field factury in Bulle/CH - CIMZIA Commercial Production - UCB Farchim S.A.

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.

Face III tablet production - Novo Nordisk A/S

- 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).

Aceptic processing - Aseptic Filling Facility -

Novo Nordisk A/S

- Air-gap projekt -

Micro dosing of silicone in primary glass containers (cartridges) for injectables.

Quality by Design project including Design of Experiments (DoE).