The starting point
Anyone who manufactures medicinal products in Germany needs a manufacturing authorisation under § 13 of the German Medicines Act (Arzneimittelgesetz, AMG), and anyone who imports them from countries outside the EU and the EEA needs an import authorisation under § 72 AMG. For both, the authorisation may be refused if there is not at least one Qualified Person (QP), called Sachkundige Person in German law, with the expertise required under § 15 AMG (§ 14(1) no. 1 AMG, applied correspondingly to imports via § 72(1) AMG). The QP’s duties are described in § 19 AMG. The QP is responsible for ensuring that each batch has been manufactured and tested in accordance with the applicable rules and certifies this in a continuously kept register or an equivalent document before the batch is placed on the market.
The law does not specify whether this person is employed by you or works for you on the basis of a contract. What matters is that the QP can fulfil their obligations at all times; otherwise the authorisation may be refused (§ 14(1) no. 4 AMG). The EU GMP Guide says something similar: the Qualified Person must be permanently and continuously at the disposal of the authorisation holder, and key positions should normally be filled by full-time staff. The question of whether an in-house or an external QP is the better fit is therefore mainly a question of organisation. It depends on how many batches you release, how close the QP needs to be to operations and how well you can cover absences.
When an in-house QP makes sense
An employed QP pays off above all when batches have to be released regularly and in larger numbers and manufacturing takes place at your own site. The QP then deals with deviations, changes and complaints every day anyway, knows the staff and the equipment, and can step in directly when problems arise. Many questions that come up during a release can be clarified more quickly in a conversation on site than by email with someone who is at the facility only a few days a month.
In addition, an in-house QP helps shape the quality system and keeps knowledge in the company. For complex products, for example sterile or biological medicinal products manufactured in house, this proximity is often hard to replace. The disadvantage is that experienced Qualified Persons are in demand and the position would not be fully utilised if batch volumes are low. Also, a lot depends on that one person. If the QP is absent or resigns, you need a replacement at short notice, and the change must be notified to the authority without delay.
When an external QP is the better fit
For smaller companies, start-ups with investigational medicinal products or companies that have their medicinal products manufactured entirely by contract manufacturers, an external QP is often the obvious solution. Actual manufacturing then takes place outside the company anyway, and a large part of the QP’s work consists of reviewing documents, assessing suppliers and keeping an eye on the supply chain.
An external model can also be a better fit for importers bringing in medicinal products from third countries, or for companies in the build-up phase whose number of batches is still hard to predict. You gain experience you would otherwise have to build up internally, and you pay according to scope instead of for a full position. In return, you have to accept that the QP is not on site every day. Because the law requires the QP to be able to fulfil their obligations at all times, availability, access to documents and processes must be regulated all the more carefully.
Mixed models
In practice the choice is rarely all or nothing. A common arrangement is an in-house QP who is deputised by an external Qualified Person during holidays, illness or bottlenecks. The EU GMP Guide only allows QP duties to be delegated to another Qualified Person, so the deputy must also have the expertise required under § 15 AMG. Clarify with your authority how the deputy is recorded in the authorisation. For the deputy arrangement to work, the deputy must know the products and the quality system before the need arises. A deputy who is only trained in an emergency delays releases exactly when it matters most.
Other companies divide the duties by product or activity, for example an in-house QP for manufacturing at the site and an external one for investigational medicinal products or imported goods. If several QPs share responsibility for a batch, Annex 16 of the EU GMP Guide requires the division to be set out in a document formally agreed by all parties. This prevents gaps and duplicate responsibilities.
What belongs in the contract
With an external QP, a written contract governs the collaboration. The AMWHV requires in any case that the Qualified Person’s area of responsibility be defined in writing or electronically. The contract should clarify at least the following points:
The individual responsibilities are often additionally set out in a delimitation of responsibilities (Verantwortungsabgrenzung). Make sure that the contract, this document and your internal work instructions are consistent with one another.
What the authority looks for
When granting the authorisation and during later inspections, the competent authority of the federal state checks whether the Qualified Person has the necessary expertise, is reliable and can fulfil their obligations at all times. With an external QP, it is to be expected that the authority will look more closely at how many other companies the person serves, how often they are on site and whether they form their own picture of manufacturing and testing rather than just signing certificates. Have evidence ready, for example visit reports and the deputy arrangement.
Frequently asked questions
Does the Qualified Person have to be our employee? +
May someone without QP qualification act as deputy? +
Can two QPs share responsibility for one batch? +
What happens if our QP is suddenly unavailable? +
Finding suitable providers
Service providers offering external Qualified Persons or deputies can be found in our directory under External QP and batch release. If you would like to have your suppliers and contract manufacturers audited before working with them, the providers of GMP audits can help you.