Alminnelige påbud

Ved all fremstilling av legemidler skal det tas de nødvendige forholdsregler for så vidt mulig å sikre at de ferdige preparatene har tilsiktet terapeutisk effekt og ikke er kontaminert med uvedkommende stoffer, mikroorganismer eller andre forurensninger i en grad som etter et faglig skjønn er utilbørlig*.

* Regler og retningslinjer for tilvirkning av farmasøytiske spesialpreparater fremgår av Eudralex Volum 4, offentliggjort av EU-kommisjonen i Brüssel: The rules governing medicinal products in the European Union – Good manufacturing practice (GMP) Guidelines

a) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products.

Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

b) Medicinal products for human and veterinary use: Good manufacturing practice

Part  I - Basic requirements for medicinal products
Part  II - Basic requirements for active substances used as starting materials (revidert pr. 1. september 2014)
Part  III - GMP related documents

• Site master file
• Q9 Quality risk management
• Q10 Note for guidance on pharmaceutical quality system

Part IV - GMP requirements for advanced therapy medicinal products

Annexes

1. Manufacture of sterile medicinal products
2. Manufacture of biological active substances and medicinal products for human use (i kraft fra 26. juni 2018). Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.
3. Manufacture of radiopharmaceuticals
4. Manufacture of veterinary medicinal products other than immunological veterinary medicinal products
5. Manufacture of immunological veterinary medicinal products
6. Manufacture of medicinal gases 
7. Manufacture of herbal medicinal products
8. Sampling of starting and packaging materials
9. Manufacture of liquids, creams and ointments
10. Manufacture of pressurised metered dose aerosol preparations for inhalation
11. Computerised systems (revidert pr. 30. juni 2011)
12. Use of ionising radiation in the manufacture of medicinal products
13. Manufacture of investigational medicinal products
14. Manufacture of products derived from human blood or human plasma (revidert pr. 30. november 2011)
15. Qualification and validation (revidert pr. 1. oktober 2015)
16. Certification by a qualified person and batch release (revidert pr. 15. april 2016)
17. Parametric release (revidert pr. 26. desember 2018)
18.  
19. Reference and retention samples