2.7) Quality Assuarance Flashcards
(16 cards)
QC and QA are used
interchangeably to ensure the quality of a service or product
Define QA
administrative and procedural activities implemented to ensure that a service or final product will pass the QC test
Define QC
a way to measure all requirements and goals for a product or service
QA prevents
errors
QC tests
final product or service to confirm that it has no errors
Define QA according to WHO
wide-ranging concept covering all matters that individually or collectively influence the quality of a product
QA plays a role in
-development
-QC
-Production
-Distribution
QA plays a role in which sectors of pharmacy
Manufacturing
Distribution
Wholesale
QA is maintained thru
adherence to GMP and GWDP
How is QA maintained at final service delivery point
thru strict SOPS as prescribed in Rules relating to GPP
Who approves the licencing of pharmaecurtical Manufacturers and WHolesalers
SAHPRA
What does SAPHRA do before granting the licence
conducts an inspection to verify that all processes adhere to GMP or GWDP requirements
Who monitors QA in pharmacutical Manufacturers
QA pharmacist- at least 1
Who monitors QA in pharmaceutical wholesalers/distributors
PAPB or PT
SAPC and its inspectorate are responsible for
inspecting CP and IP to ensure they adhere to GPP
Adhering to GPP ensures
quality in a CP and IP
