PIC/S ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION (PI 038-2)
Title:
PIC/S ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION (PI 038-2)
Short Title:
PI 038-2
Origin/Publisher:
Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Document Type:
Aide Memoire
Content:
The purpose of this document is to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Parts of this Aide-Memoire may also be useful(with suitable modification) during other GXP inspections where similar principles of QRM also apply