Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients

The German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients is an ordinance for the implementation of the practice for product with human origin. It was issued by the Federal Ministries of Health and Food, Agriculture and Consumer Protection in agreement with the Federal Ministers of Economics, Technology and the Environment and with the consent of the Federal Council.

Computer-based system are dealt with in section 2, §10 of the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients. It specifies that companies and organizations have to maintain a documentation system in accordance with the respective activities performed. The documentation must be maintained clearly and without errors and must be up-to-date. If records are kept with electronic data processing systems, the system must be sufficiently validated. It is an underlying requirement to ensure that the information is available during the entire legal retention period and can be provided in legible form in a reasonable amount of time. The data must be protected against loss or damage during the entire retention period. The records must be organized in a way allowing for an immediate recall of the product. With reference to the software, the vendor thus has to guarantee that this is always available and the documentation can be accessed at any time.
Finally, §20 “Storage of the documentation” (“Aufbewahrung der Dokumentation”) requires that any documents may only in rooms which are regarded as adequate and approved in the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients. The room typically has to be located on the company’s premises. Fort further details on the contained requirements, the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients refers to the EU-GMP guideline.