Qualified person service (QP 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.