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Põhinõuded. Tellimustööd. GMP Part I - Basic Requirements for Medicinal Products Chapter 7 Outsourced activities

08.01.2013
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Chapter 7 on täiendatud ning avaldatud uue versioonina

http://ec.europa.eu/health/files/eudralex/vol-4/vol4-chap7_2012-06_en.pdf

Uus versioon jõustub 31. jaanuaril 2013.
 

Senises Chapter 7 algtekstis olnud mõiste contract manufacture and analysis on asendatud laiema mõistega: outsourced activities.
 

Muutmise üks eesmärk oli viia GMP kooskõlla ICH juhendiga Q10 Pharmaceutical Quality System.
http://www.ich.org/
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

 

Chapter 7 ulatus on nüüd laiem.
Senine tekst ütles: Contract manufacture and analysis must be /.../
Uus versioon ütleb: Any activity covered by the GMP Guide that is outsourced should be /.../.

Tekst on üksikasjalikum kui senini, lisatud on uusi sätteid. Näiteks:
Prior to outsourcing activities, the Contract Giver is responsible for assessing the legality, suitability and the competence of the Contract Acceptor.
The Contract Giver should monitor and review the performance of the Contract Acceptor and the identification and implementation of any needed improvement.
Arrangements made between the Contract Acceptor and any third party should ensure that information and knowledge, including those from assessments of the suitability of the third party, are made available /.../
The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer /.../


Kaasatud on olukord, kus ravimi tootja ja ravimi müügiloa hoidja on eri isikud.

Endiselt räägitakse nii lepingust contract kui tehnilistest kokkulepetest technical arrangements;
viimaste koostamises peavad osalema inimesed, kellel on sisulised teadmised tööst ja GMP nõuetest.