GMP: QA

Question 1

What decisions can consumers NOT make about drugs?

Answer 1

When to use, which to use, how to use, potential benefits and risks

Question 2

Why is it important to regulate drugs?

Answer 2

To prevent therapeutic failure, exacerbation of disease, resistance to medicines, and death

(from ineffective, poor quality, harmful meds)

Question 3

Who regulates drugs?

Answer 3

FDA,
EMEA,
Ministry of Health and Welfare,
MHRA, ICH

Question 4

What is an active pharmaceutical ingredient (API)?

Answer 4

A drug in regulatory terms

Question 5

What are the components of a medicine?

Answer 5

API, inactive ingredients (excipients), packaging components

Question 6

What does the pharmaceutical industry do?

Answer 6

Develops medicines, makes a profit, provides therapies, conducts research, has social impact

Question 7

What evidence do governments require for product approval?

Answer 7

Safety,
effectiveness,
suitable quality

Question 8

How is the quality of medicine assured?

Answer 8

Through robust development processes

Question 9

What exists to control the approval of new products?

Answer 9

A regulatory system

Question 10

What is the role of the FDA?

Answer 10

To regulate and supervise the safety and efficacy of pharmaceuticals in the US

Question 11

What is the role of the EMEA?

Answer 11

To evaluate and supervise the safety and efficacy of pharmaceuticals in the EU

Question 12

What is the role of the MHRA?

Answer 12

To ensure that medicines and medical devices meet applicable standards of safety, quality, and efficacy in the UK

Question 13

What is the role of the Ministry of Health and Welfare?

Answer 13

To regulate and supervise the safety and efficacy of pharmaceuticals in their respective countries

Question 14

What is cGMP?

Answer 14

Current Good Manufacturing Practices
- minimum standards for pharmaceutical companies to comply with to ensure products are pure, safe, and effective.

Question 15

Why do we need cGMP?

Answer 15

ensure high level of quality and consistency in manufacture of therapeutic products + protect end user.

Question 16

What are the basic requirements of products in cGMP?

Answer 16

fit end purpose..

Free from contamination.
Contain the correct dose.
Have not deteriorated.
Provide the required therapeutic benefit.

Question 17

Who’s responsibility is it to ensure all processes comply with cGMP?

Answer 17

companies

Question 18

What is the difference between quality assurance and quality control?

Answer 18

QA is responsible for the overall quality of product

QC is responsible for sampling and testing raw materials.

Question 19

What term encompasses GMP and QC?

Answer 19

quality assurance

Question 20

What is the purpose of planned & periodic audits?

Answer 20

Ensure compliance with cGMP

Question 21

What is the responsibility of QC?

Answer 21

Sampling and testing of raw materials, intermediate products, and final products

Question 22

What are the requirements for a QC department?

Answer 22

Trained personnel, approved procedures and testing methods, maintenance of records, sufficient reference samples

Question 23

What is the role of QC in GMP?

Answer 23

Ensure no materials or products are released until quality is evaluated and judged satisfactory

Question 24

what ensures delivery of high quality products?

Answer 24

QA

Question 25

What is ICH Q10?

Answer 25

Pharmaceutical Quality System - captures QA

Question 26

What should Quality Assurance ensure about product design?

Answer 26

Based on sound scientific rationale and with GMP or GLP principles

Question 27

Why are Good Laboratory Practices (GLP) important?

Answer 27

to ensure products are developed that are fit for purpose from the start.

Question 28

What should Quality Assurance ensure about production and control operations?

Answer 28

Clearly specified and GMP is adopted

Question 29

What is the objective of GLP?

Answer 29

Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates

Question 29

What is the objective of GLP?

Answer 29

Promote the quality & validity of data generated in the testing of pharmaceutical products, raw materials, manufacturing intermediates

Question 30

What is the importance of GLP?

Answer 30

Assure regulatory authorities that data submitted are a true reflection of the results obtained during the study & can therefore be relied upon

Question 31

What are the three main goals of drug quality assurance?

Answer 31

Protection of human health & the environment, Time & resource efficiency, Avoidance of non-tariff barriers to trade

Question 32

What is the purpose of Chemistry, Manufacturing and Controls (CMC)?

Answer 32

To build QUALITY into the product by assuring consistency and appropriate standards

Question 33

What connection does CMC help maintain?

Answer 33

Quality between the drug used in clinical trials and the marketed drug.

Question 34

What are some critical elements of CMC?

Answer 34

Raw material quality control, process control, sterilization validation, shelf life/expiry validation

Question 35

What is the connection between CMC and drug quality in clinical studies and marketed drugs?

Answer 35

CMC helps maintain the connection in quality between the drug used in clinical studies and the marketed drug

Question 36

What is the purpose of commercial batches and process validation batches?

Answer 36

To ensure consistency and quality of the product marketed to consumers

Question 37

How is the connection between clinical and commercial batches made?

Answer 37

Through pilot batches and scale-up from engineering batches.

Question 38

What should be consistent across batches at each stage?

Answer 38

Processes and raw materials.

Question 39

What CMC factor is of particular concern for sterile injectable products?

Answer 39

sterility and endotoxin concentration.

Question 40

What CMC factor is of particular concern for controlled-release products?

Answer 40

release profile of API over time

Question 41

What CMC factor is of particular concerns for oral tablets?

Answer 41

dissolution profile

Question 42

What CMC factors are of particular concern for soluble powders for drinking water?

Answer 42

moisture content of powder. solubility in water.

Question 43

What does CMC stand for?

Answer 43

Chemistry, Manufacturing, and Controls.

Question 44

Why is testing alone of the finished drug product insufficient for control of product quality?

Answer 44

The manufacturer should know which steps and variables in the manufacturing process need to be controlled and why.

Question 45

What is the foundation of a controlled manufacturing process?

Answer 45

Process understanding.

Question 46

Why is process understanding vital to quality and consistency?

Answer 46

The manufacturer that understands the sources of variability in its process can preempt problems and quickly find the root cause and fix it.

Question 47

What are the factors that should be constant (or improve) for product quality?

Answer 47

Raw material suppliers, manufacturing sites, manufacturing processes, manufacturing equipment, packaging, specifications, testing procedures.

Question 48

Why are manufacturing changes inevitable over time?

Answer 48

Over time, change is inevitable.

Question 49

What are the stages of the drug development process?

Answer 49

Drug discovery and screening, preclinical testing and IND application, human clinical trials: Phase I, II, III, new drug application, full-scale manufacturing.

Question 50

What is the timeline for drug development?

Answer 50

3 to 6 years for preclinical, 6 to 7 years for clinical, 1 to 3 years for post-market.

Question 51

What are the types of continuous testing?

Answer 51

GLP, GCP, GMP.