QA/QC

Question 1

What are the main responsibilities of a QA department in a Pharmaceutical facility?

Answer 1

QA involves ensuring that the quality requirements are met, by preventing defects from occurring. It is usually considered the first eyes in preventing non-conformances and is process oriented.
QA - responsibilities :
- Management – CAPA, change control of system, Controlled documentation (SOP, master) , regulatory audits/inspections
- Approvals – maintanence and calibration programs, technology transfer, batch/product documentation review and approvals.
- Self inspection (internal audits)
- Control of quarinten system
- Training programs (GMP, GDP)

Question 2

What are the main GMP requirements for the QC department?

Answer 2

CUE, CIA

QA involves ensuring that the quality requirements are met, by preventing defects from occurring. It is usually considered the first eyes in preventing non-conformances and is process oriented.
QC responsibilities (CUE, CIA)
Conduction stability studies
Carrying our sampling and testing of products
Using analytical method validation
Environmental monitoring using qc incubates plates
Investigating test failures such as OOS
Analyse trends, data and reports.