In detail
Legal basis and scope
The AMWHV of 3 November 2006 is an operating ordinance within the meaning of § 54 of the German Medicinal Products Act (AMG). It transposes several EU directives, including Directive 2003/94/EC on Good Manufacturing Practice. Under § 1 AMWHV, it applies to establishments that commercially manufacture, test, store, place on the market, import or export medicinal products, active substances, certain substances of human origin or tissues. Marketing authorisation holders and other pharmaceutical companies placing medicinal products on the market, as well as active substance traders, are also covered. For investigational medicinal products within the scope of Regulation (EU) No 536/2014, § 1(7) provides that the AMWHV applies only where individual provisions expressly refer to that Regulation.
Link to the EU GMP Guide
Under § 3(2) AMWHV, Good Manufacturing Practice is interpreted using Part I of the EU GMP Guide for medicinal products, Part IV for advanced therapy medicinal products and Part II for active substances. The Federal Ministry of Health publishes the current version in the Federal Gazette (Bundesanzeiger). In this way, the AMWHV makes the guide binding in Germany.
Personnel and responsibilities
§ 4 AMWHV requires sufficient qualified personnel, job descriptions and an organisation chart with no gaps between areas of responsibility. § 12 AMWHV provides:
The responsibilities of the Qualified Person must be set out in writing or electronically in accordance with § 19 AMG.
The Head of Production ensures, among other things, that products are manufactured and stored correctly and approves the manufacturing instructions.
The Head of Quality Control approves or rejects starting materials, approves specifications and test instructions and supervises contract laboratories.
The two functions must be independent of each other.
Companies placing finished medicinal products on the market must also define the responsibilities of the Stufenplanbeauftragter (German QPPV) under § 63a AMG and the information officer under § 74a AMG.
Further content
The ordinance also covers premises, hygiene, storage and transport, contracted activities, documentation, self-inspections and supplier qualification. § 16 AMWHV sets out the conditions under which the Qualified Person under § 14 AMG may release a batch for placing on the market.
In practice at A&O Pharma
A&O Pharma holds its own manufacturing authorisation under § 13 AMG and therefore knows the requirements of the AMWHV from its own operations. We take on functions such as Qualified Person under § 14 AMG, Stufenplanbeauftragter under § 63a AMG and information officer under § 74a AMG at your site on a temporary basis, and we support you during regulatory inspections.
GMP and GxP Consulting & QA SupportFrequently asked questions
Where are the duties of the Head of Production and Head of Quality Control set out?
In § 12 AMWHV. It lists the duties of both functions and requires them to be independent of each other.
Does the AMWHV apply to investigational medicinal products?
For investigational and auxiliary medicinal products within the scope of Regulation (EU) No 536/2014, only where individual provisions of the AMWHV expressly refer to that Regulation (§ 1(7) AMWHV).
How do the AMWHV and the EU GMP Guide relate to each other?
§ 3(2) AMWHV states that Parts I, II and IV of the EU GMP Guide are used to interpret Good Manufacturing Practice. This makes the Guide binding for German companies.
