GMP : Quality Assurance

Question 1

State the GMP objective

Answer 1

To assure quality of product for safety, well-being and patient protection

Question 2

The concept of GMP is to reduce/increase the risk of making mistakes during all stages

Answer 2

reduce

Question 3

Describe the Devonport incident

Answer 3

A 5% drip solution was non-sterile leading to 5 deaths
Total batch = 4000
1/3 of the batch was contaminated
Fault detected 10 months after manufacture

Question 4

What went wrong in the Devonport incident?

Answer 4

Fault temp. recorders in autuoclave drains
Blocked drain + debris found in autoclave
Ran the autoclave for 40 mins at 120 degrees - too long and too high
They did not have adequately trained staff

Question 5

List the findings of the Clothier Report of the Devonport incident

Answer 5

Lack instrument calibration
Lack of maintenance
Inadequate procedures
Poor staff
No batch records
Inadequate equipment and cleaning

Question 6

List the basic requirements of GMP

Answer 6

Consistent manufacturing process
Provided facilities
Trained staff
Records
Systems able to recall batches
Complaints examined

Question 7

List the effects of the Clothier Report

Answer 7

• Ensure critical instruments were functional and calibrated regularly
• Prove SOP’s were accurate
• Prove operators were trained
• Test & prove the process would work time & time again
• Document it had been done

Question 8

List the 4 main aspects of GMP

Answer 8

• Planning
• Documentation
• Equipment & facility
• Quality control

Question 9

What is a qualified person (QP)?

Answer 9

• Responsible for releasing products onto market for clinical trials
• Actively involved in all aspects to quality in organisation
• Well paid job with huge responsibility

Question 10

List the objective of QC

Answer 10

• Defined process that will yield a product complying with its specifications

Question 11

List examples of documentation in GMP

Answer 11

• Equipment cleaning and use recorded
• Record of raw materials, intermediates, API labelling & packaging
• Laboratory control records
• Product review

Question 12

Quality control can only detect extreme _____

Answer 12

failure