In detail
Legal basis
The German term Sachkundige Person originates in § 14(1) no. 1 of the German Medicinal Products Act (AMG): a manufacturing authorisation may be refused if there is not at least one person with the expertise required under § 15 AMG who is responsible for the activity described in § 19 AMG. § 19 AMG defines that activity: the QP is responsible for ensuring that each batch has been manufactured and tested in accordance with the legislation on medicinal products, and certifies this in a continuous register or comparable document before the batch is placed on the market. At EU level, the corresponding provisions are Articles 48 to 51 of Directive 2001/83/EC and, for investigational medicinal products, Article 62 of Regulation (EU) No 536/2014.
Duties in batch release
The release process is set out in more detail in § 16 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) and in Annex 16 of the EU GMP Guide. Under § 16(2) AMWHV a batch may only be released if, among other things,
the manufacturing and testing records have been properly signed,
manufacturing conditions and in-process control results have been considered alongside the analytical results,
the batch complies with the marketing authorisation dossier or, for investigational medicinal products, with the clinical trial authorisation documents.
Annex 16 adds further points, such as a documented supply chain for the active substance, audits of the sites involved and completed investigations into deviations and out-of-specification results. Individual tasks may be delegated to trained staff. Under § 16(4) AMWHV the QP remains personally responsible for the release of the batch as a whole.
Requirements
The required expertise is defined in § 15 AMG: either a licence to practise as a pharmacist or a degree following at least four years of university study in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human or veterinary medicine, in each case combined with at least two years of practical experience in qualitative and quantitative analysis and other quality testing of medicinal products. Different requirements apply to blood preparations, vaccines, advanced therapy medicinal products and other product groups. Under § 16(6) AMWHV the QP may only be deputised by persons with the same expertise.
In practice at A&O Pharma
Under its own manufacturing authorisation (§ 13 AMG), A&O Pharma performs QP certification of investigational medicinal products under Regulation (EU) No 536/2014 and EU batch certification of authorised medicinal products in line with Annex 16. Through our interim management service we also provide Qualified Persons under § 14 AMG at your site on a temporary basis.
QP Batch ReleaseFrequently asked questions
What qualifications does a Qualified Person need?
Under § 15 AMG, either a licence to practise as a pharmacist or at least four years of university study in a subject such as pharmacy, chemistry, biology or medicine. In both cases at least two years of practical experience in the analysis and quality testing of medicinal products are required as well.
Can a Qualified Person delegate tasks?
Yes, Annex 16 allows individual checks to be delegated to trained staff or third parties. Under § 16(4) AMWHV the QP remains personally responsible for the release of the batch as a whole.
What happens if the Qualified Person is unavailable?
In cases of short-term absence, § 16(6) AMWHV allows deputisation only by persons with the expertise required under § 15 AMG. An unforeseen change of QP must be notified to the authority without delay under § 20 AMG.
