PharmDev Innovations

QP Contractors

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.

Scenarios

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 ยง4 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:

  1. 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)
  2. Delimitation of own responsibility as a QP against other involved QPs in the supply chain as laid down in EU GMP Annex 16
  3. 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.
  4. support of contract giver in all relevant regulatory topics related to release / certification and quality assessment of drugs (in particular IMPs)

 

 

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