In detail
Legal basis and scope
The AMWHV of 3 November 2006 is an operating ordinance within the meaning of Section 54 of the German Medicinal Products Act (AMG). It transposes several EU directives, including Directive 2003/94/EC on Good Manufacturing Practice. Under Section 1, 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. Pharmaceutical entrepreneurs, such as marketing authorisation holders, and active substance traders are also covered. For investigational medicinal products within the scope of Regulation (EU) No 536/2014, Section 1(7) provides that the AMWHV applies only where individual provisions expressly refer to that Regulation.
Link to the EU GMP Guide
Under Section 3(2), Part I of the EU GMP Guide applies to the interpretation of Good Manufacturing Practice 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. In this way, the AMWHV makes the guide binding in Germany.
Personnel and responsibilities
Section 4 requires sufficient qualified personnel, job descriptions and an organisation chart with no gaps between areas of responsibility. Section 12 provides:
The responsibilities of the Qualified Person must be set out in writing or electronically in accordance with Section 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 heads must be independent of each other.
Companies placing finished medicinal products on the market must also define the responsibilities of the graduated plan officer under Section 63a AMG and the information officer under Section 74a AMG.
Further content
The ordinance also covers premises, hygiene, storage and transport, contracted activities, documentation, self-inspections and supplier qualification. Section 16 sets out the conditions under which the Qualified Person under Section 14 AMG may release a batch for placing on the market.
In practice at A&O Pharma
A&O Pharma operates under its own manufacturing authorisation pursuant to Section 13 AMG and therefore knows the requirements of the AMWHV from its own operations. We take on functions such as Qualified Person under Section 14 AMG, graduated plan officer under Section 63a AMG and information officer under Section 74a AMG on a temporary basis at your site, and we support you during regulatory inspections.
GMP & GxP Consulting & QA SupportFrequently asked questions
Where are the heads of production and quality control regulated?
In Section 12 AMWHV. It lists the duties of both functions and stipulates that they must 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 (Section 1(7) AMWHV).
How do the AMWHV and the EU GMP Guide relate to each other?
Section 3(2) AMWHV states that Parts I, II and IV of the EU GMP Guide apply to the interpretation of Good Manufacturing Practice. This makes the guide binding for German companies.
