WHO Good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
Title:
WHO Good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions
Short Title:
TRS 1010 - Annex 9
Origin/Publisher:
WHO headquarters, Avenue Appia 20, 1211 Geneva 27, Switzerland Telephone: (+ 41 22) 791 21 11, Facsimile (fax): (+ 41 22) 791 3111, Telex: 415 416, Telegraph: UNISANTE GENEVA
Content:
This guidance aims at providing an approach for use by NRAs for assessing compliance with GMP, GLP or GCP using documentation issued by other NRAs in lieu of conducting an inspection of a specific site