Split of responsibility

As a part of your job you need to know who is doing the final approval of a material, a process, a part delivery or the final product to the market. In this short e-learning you will be presented with a high level description of the division of responsibility and tasks. 

The Qualified Person

The single point of entry for Quality

In Novo Nordisk the overall responsibility for Quality is situated with the Superior Qualified Person. We are an organisation based on trust so in practice this responsibility is delegated to the relevant employee in the Quality Organisation.

Superior Quality Person's responsibility

  • The Superior Qualified Person gets all batches ready for release by his/her table to release them formally for the market.

Product quality is assured by a series of reviews ensuring the right documentation in the right state of completion is in place. This is to ensure patient safety,  product quality and compliance.

We therefore have an entire quality assurance organisation ensuring this quality control with the Superior Qualified Person as the overall responsible.

Delegation of responsibility

Who is doing what?

As mentioned earlier the Superior Qualified Person cannot do everything and neither can the QP of PS. Please navigate through the below image to find out who has what responsibility in releasing the product. 

The value chain

A high level

As you can see on the on the image below there are four contributors to the production of a finished product. 

Sourcing & Operation (SoOp) provides all the raw materials as well as all other materials used in production i.e. packaging and labels. Whenever a material arrives or leaves one of the SoOp facilities they are going through the release procedure and are signed for.

Active Pharmaceutical Ingredient (API) makes the base element of our finished product.

Aseptic Product (AP) fills the vials with the medicine.

Finished Products (FP) assembles the end product i.e. a Tresiba pen.

We have split the responsibility of releasing the product to market into four overall parts equal to the four contributors to the finished product. Navigate through the below image with the mouse to get the full picture of each part.

Who would be required to have a QP?

  • Sourcing & Operation
  • AP
  • API
  • FP

QA is releasing the product in all areas of responsibility. For which areas should a QA be appointed QP to release products in accordance with EU GMP Annex. 

Please choose the correct answer(s)