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GMP News No. 401
31 March 2004
Revision of Directive2001/83/EC –
There are three major consequences for the API manufacturers:
(A) APIs have to be manufactured in accordance to Annex 18 EG GMPGuide:
The EG GMP Guide obliges pharmaceutical companies to purchase APIs fromapproved suppliers only. The amended Directive increases the pressure onthe pharmaceutical company: according to article 46f the pharmaceuticalcompany is obliged "(…) to use as starting materials only activesubstances, which have been manufactured in accordance with the detailedguidelines on good manufacturing practice for starting materials (comment:reference is made to the Annex 18 to the EU GMP Guide). This point shallalso be applicable to certain excipients, the list of which as well as thespecific conditions of application shall be established by a Directiveadopted by the Commission in accordance with the procedure referred to inArticle 121(2).
Annex 18 to the EU GMP Guide can be found here:
(B) Annex 18 of the EU GMP Guide (GMP for APIs) becomes mandatory forthe EU:
(C) Inspections at the premises of API manufacturers may be carriedout:
In order to verify whether the data submitted in order to obtain aconformity certificate comply with the monographs of the EuropeanPharmacopoeia, the standardisation body of the nomenclatures and thequality norms within the meaning of the Convention relating to theelaboration of the European Pharmacopoeia (European Directorate for thequality of Medicinal Products) may ask the Commission or the Agency torequest such an inspection when the starting material concerned is thesubject of a European Pharmacopoeia monograph.
The competent authority of the Member State concerned may carry outinspections of starting material manufacturers at the specific request ofthe manufacturer himself.
Unfortunately the different wordings of 'APIs' in Annex 18 and in theDirective may cause confusion: Annex 18 uses the word 'activepharmaceutical ingredient', the amended Directive uses 'startingmaterial'.
*1: Many thanks to Dr Chris Oldenhof fromDSM, Netherlands, for the link and the latest information on the newDirective.