Qualified person service
We support companies in fulfilling their legal obligations as manufacturing authorisation holders – and provide a qualified person (QP) a short- or long-term basis.
A QP in accordance with Directive 2001/83/EC plays a key role at a pharmaceutical company. He or she is responsible for making sure production, testing and batch release fulfil all pharmaceutical regulations.
Our QPs are on-site
The sudden, unplanned absence of a QP can be a problem for the MAH. In situations like this a qualified person from Diapharm is available to support our clients. Short term or long term – and on location if need be. Right then when they are needed most. And without any personnel based commitments. Our QP service can:
- Take on the duties and responsibilities of a qualified person for the long term
- Provide temporary help, e.g. to tide over staffing transitions
- To appoint an additional qualified person to fill in when employees are unavailable due to illness or PTO/holiday
- To expand capacities, e.g. a QP for special areas
QP service for special requirements
Diapharm’s qualified person service (QP service) provides MAHs with a highly experienced QP in accordance with Directive 2001/83/EC. We are also able to meet special requirements, such as monitoring sterile production or medicinal products for advanced therapies. Our QP service is available on a per-day or per-week basis.