My presentation at the recent ECA QP Forum included QP oversight of the distribution of the finished medicinal product, after QP certification.

Questions were raised as to the level of involvement that a QP should have in the distribution of the finished product after QP certification. After all, Annex 16 only states that QPs should have oversight of the supply chain from active substances to finished product certification.

We didn't have enough time to dive into the details of this during the Q&A session, so I've decided to write this blog. Hopefully it will reach (some of) the QPs who wanted this point clarified.

Let's start right from the beginning, with Directive 2001/83/EC.

Definition of wholesale distribution of medicinal products:

All activities consisting of procuring, holding, supply or exporting medicinal products, apart from supply medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned.

From this definition, we see that Manufacturers also can undertake wholesale distribution of medicinal products covered by their manufacturing authorisation.

Dir 2001/83/EC article 77(3):

Possession of a manufacturing authorisation shall include authorisation to distribute by wholesale the medicinal products covered by that authorisation.

Now what do the GDP guidelines 2013/C 343/01 say?

2013/C 343/01, Introduction paragraph 9:

Possession of a manufacturing authorisation includes authorisation to distribute the medicinal products covered by the authorisation. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.

What does this mean to the QP?

If the QP is named on the manufacturing authorisation of a manufacturer that also undertakes wholesale distribution of medicinal products covered by that manufacturing authorisation, the QP must ensure that the distribution activities comply with GDP.

For the wholesale distribution activities performed under the manufacturing authorisation, the QP fulfills the role of the "Responsible Person" as described in chapter 2.2. of the GDP guidelines.

Why does Annex 16 only talk about QP oversight of the supply chain up to finished product certification?

Well, that's simple - Annex 16 is entitled "Certification by a Qualified Person and Batch Release". Therefore, the scope of Annex 16 ends with batch certification and release to saleable stock.

The next stage after release to saleable stock would be distribution of the finished medicinal product, which is covered in detail in the GDP guidelines 2013/C 343/01.

Summing up:

When considering the extent of the responsibilities of the QP, we should not only look at Annex 16, but go back to the ground rules, which are laid out in Dir 2001/83/EC, then work back up, lining up the pieces of the different directives and guidelines. The responsibilities detailed in Annex 16 are only with respect to QP certification and batch release, while the full extent of QP responsibilities goes further than that.