pharmaceutical qaulity 3 Flashcards
1
Q
key components of GMP
A
quality management personell premises and equipment documentation production QC contract manufacture and analysis complaint and product recall self-inspection
2
Q
in quality management the product is made for the
A
intended use
3
Q
in quality management the system should be
A
fully documented
4
Q
in quality management there should be good system with
A
GMP
QC
5
Q
for complaint and product recall :
they are ….. with a written procedure
A
reviewed
6
Q
for complaint and product recall :
self-insepction
A
internal audits can be carried out
7
Q
role of QA
A
effective QMS should be in place
8
Q
Through these processes: what increases
- production of API start material
- intro of API starting material
- production of intermediate
- isolation and purification of product
- physical processing and packaging
A
GMP requirements will increase
