quality assurance

Question 1

role of QA

Answer 1

ensures systems and PROCEDURES in place CONSISTENTLY produce QUALITY
- create implement and maintain QMS to describe how a company complies with GMP

Question 2

roles of QA

Answer 2

1. QMS
2. Audits and Investigations
3. documentation and training
4. manufacturing
5. lab TESTS and CONTROL
6. review and approve/reject all thing GMP related
7. keep MANAGEMENT INFORMED
8. QA responsibilities in writing
9. remain INDEPENDENT

Question 3

QMS

Answer 3

create, maintain and implement a quality management system
describes how a compnay complies with GMP

Question 4

audits and investigations

Answer 4

ensure what’s written on paper is actually happening
report on performance of quality system

Question 5

Documentation and Training

Answer 5

training records on site

Question 6

manufacturing

Answer 6

IN-PROCESS CONTROLS are implemented
need to be performed during manufacturing
separate batch records needed for manufacturing and packaging
manufacturing batch records must contain any inprocess controls

Question 7

lab tests and control

Answer 7

QC = preforms tests
QA = ensure correct documentation using validated test methods
implement a RE-TEST programme to re-test approved components

Question 8

review and approve/reject ALL things GMP - also QC

Answer 8

• any documents that contain instructions or set requirements
• reprocessing or rework procedures
• manufacturing batch records
• make decision to approve product on to market

Question 9

describe responsibilities of QA in writing

Answer 9

written SOPS
need following

Question 10

remain independent

Answer 10

NO conflict of interest between regulatory responsibilities and daily activities
independently review aand approve

Question 11

keep management informed

Answer 11

inform of produce, process and system risks
outcome of regulatory inspections