top of page

EU & MHRA (유럽 & 영국)

[MHRA]

3.

‘GXP’ Data Integrity Guidance and Definitions

[EMA]

2.

Guidance on good manufacturing practice and good distribution practice: Question and answers - Data integrity Guidance

[EudraLex]

1.

Volume 4 Good Manufacturing Practice (GMP) Medicinal Products for Human and Veterinary Use - Annex11 : Computerised Systems

bottom of page