Our business unit PharmQP Contractors is offering all activities and responsibilities normally pursued by a Qualified Person.
We do have the necessary qualification for a QP acknowledged by the authorities (confirmation available on request; in german language).
We normally make use of our client's own manufacturing authorisation and get listed in the respective files of the authority as responsbile QP.
Usual scenario is a s follows:
Function of Qualified Person is performed on contract base and not on full employment - in this case the QP ist to be named as a freelancer in the contract giver's manufacturing authorisation (which requires that the contract giver has a MA, of course).
Qualification requirements for acting as a QP must be met, of course.
Our offering in particular comprises the QP release for investigational medicinal products, which is a special challenge.
EU-GMP Annex 13 requests in §4 an additional qualification then for the QP:
"The Qualified Person should in particular be responsible for ensuring that there are systems in place that meet the requirements of this Annex and should therefore have a broad knowledge of pharmaceutical development and clinical trial processes."
Our unit PharmQP is covering the following tasks:
- Auditing manufacturing and quality control areas of our contract giver as a prerequisite for assessment of contract giver's quality managament system (which again is a prerequisite for acting as a QP there)
- Delimitation of own responsibility as a QP against other involved QPs in the supply chain as laid down in EU GMP Annex 16
- release / certification of drugs based on the technical agreement between the contract QP and the contract giver (quality agreement) and the documents provided as requested for releasing activities.
- support of contract giver in all relevant regulatory topics related to release / certification and quality assessment of drugs (in particular IMPs)