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Lab 3 > GMP: QA > Flashcards

GMP: QA Flashcards

1
Q

What decisions can consumers NOT make about drugs?

A

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

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2
Q

Why is it important to regulate drugs?

A

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

(from ineffective, poor quality, harmful meds)

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3
Q

Who regulates drugs?

A

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

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4
Q

What is an active pharmaceutical ingredient (API)?

A

A drug in regulatory terms

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5
Q

What are the components of a medicine?

A

API, inactive ingredients (excipients), packaging components

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6
Q

What does the pharmaceutical industry do?

A

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

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7
Q

What evidence do governments require for product approval?

A

Safety,
effectiveness,
suitable quality

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8
Q

How is the quality of medicine assured?

A

Through robust development processes

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9
Q

What exists to control the approval of new products?

A

A regulatory system

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10
Q

What is the role of the FDA?

A

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

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11
Q

What is the role of the EMEA?

A

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

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12
Q

What is the role of the MHRA?

A

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

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13
Q

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

A

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

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14
Q

What is cGMP?

A

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

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15
Q

Why do we need cGMP?

A

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

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16
Q

What are the basic requirements of products in cGMP?

A

fit end purpose..

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

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17
Q

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

A

companies

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18
Q

What is the difference between quality assurance and quality control?

A

QA is responsible for the overall quality of product

QC is responsible for sampling and testing raw materials.

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19
Q

What term encompasses GMP and QC?

A

quality assurance

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20
Q

What is the purpose of planned & periodic audits?

A

Ensure compliance with cGMP

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21
Q

What is the responsibility of QC?

A

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

22
Q

What are the requirements for a QC department?

A

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

23
Q

What is the role of QC in GMP?

A

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

24
Q

what ensures delivery of high quality products?

A

QA

25
Q

What is ICH Q10?

A

Pharmaceutical Quality System - captures QA

26
Q

What should Quality Assurance ensure about product design?

A

Based on sound scientific rationale and with GMP or GLP principles

27
Q

Why are Good Laboratory Practices (GLP) important?

A

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

28
Q

What should Quality Assurance ensure about production and control operations?

A

Clearly specified and GMP is adopted

29
Q

What is the objective of GLP?

A

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

29
Q

What is the objective of GLP?

A

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

30
Q

What is the importance of GLP?

A

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

31
Q

What are the three main goals of drug quality assurance?

A

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

32
Q

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

A

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

33
Q

What connection does CMC help maintain?

A

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

34
Q

What are some critical elements of CMC?

A

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

35
Q

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

A

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

36
Q

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

A

To ensure consistency and quality of the product marketed to consumers

37
Q

How is the connection between clinical and commercial batches made?

A

Through pilot batches and scale-up from engineering batches.

38
Q

What should be consistent across batches at each stage?

A

Processes and raw materials.

39
Q

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

A

sterility and endotoxin concentration.

40
Q

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

A

release profile of API over time

41
Q

What CMC factor is of particular concerns for oral tablets?

A

dissolution profile

42
Q

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

A

moisture content of powder.
solubility in water.

43
Q

What does CMC stand for?

A

Chemistry, Manufacturing, and Controls.

44
Q

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

A

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

45
Q

What is the foundation of a controlled manufacturing process?

A

Process understanding.

46
Q

Why is process understanding vital to quality and consistency?

A

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

47
Q

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

A

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

48
Q

Why are manufacturing changes inevitable over time?

A

Over time, change is inevitable.

49
Q

What are the stages of the drug development process?

A

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

50
Q

What is the timeline for drug development?

A

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

51
Q

What are the types of continuous testing?

A

GLP, GCP, GMP.

Lab 3 (21 decks)

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