Roles and duties

Question 1

Duties of the QP (General principles)

(General principles)

Answer 1

Each batch is manufactured and checked in compliance with laws in force in the member state where certification takes place, in accordance with the requirements of the Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP)

Question 2

What about medicinal products from third countries?

Answer 2

Each production batch has in a member state undergone full qualitative analysis, a quantitative analysis of at least all of the active substances and all the other tests and checks necessary to ensure the quality of medicinal products in accordance with the requirements of the MA. The QP must certify in a register or equivalent document that each production batch satisfies the requirements of article 51

Question 3

ITS QA VAIDERS MAGIC CATS

Answer 3

Investigations
TSE
Sites
QC
Activities
Validated
API’s
Inspection
Distribution
Excipients
Records
Supply chain
Marketing
Audits
GMP
Import
Changes
Complaints
Agreements
Tampers
Source and Specs