M1 INTRODUCTION TO QUALITY CONTROL AND QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS

Question 1

Dimensions of Quality (Garvin, 1987)

Answer 1

A. Aesthetics
B. Features
C. Perceived Quality
D. Conformance to Standards
E. Performance
F. Reliability
G. Durability
H. Serviceability

Question 2

“How often does the product fail?”

Answer 2

Reliability

Question 3

“Our internet connection never disappoints us.”

Answer 3

Reliability

Question 4

“Will the product do the intended job?”

Answer 4

Performance

Question 5

“The ballpen I bought writes smoothly”.

Answer 5

Performance

Question 6

“How long does the product last?

Answer 6

Durability

Question 7

“Our electric fan is still working since 1989.”

Answer 7

Durability

Question 8

“How easy is it to repair the product?”

Answer 8

Serviceability

Question 9

“I accidentally downloaded a malware in my phone. Good thing the Service Center was able to remove it.”

Answer 9

Serviceability

Question 10

“What does the product look like?”

Answer 10

Aesthetics

Question 11

“The shoes I purchased online looks authentic.”

Answer 11

Aesthetics

Question 12

“Samsung S9 offers iris/fingerprint scanner and fast battery charging.”

Answer 12

Features

Question 13

“What does the product do?”

Answer 13

Features

Question 14

“What is the reputation of the company or its product?

Answer 14

Perceived Quality

Question 15

“Where do you usually buy your medicines?”

Answer 15

Perceived Quality

Question 16

“Is the product made exactly as the designer intended?”

Answer 16

Conformance to Standards

Question 17

“The tailored uniform fits perfectly. ”

Answer 17

Conformance to Standards

Question 18

Quality is fitness for use

Answer 18

– Juran, 1988
– It places emphasis on the consumer aspect of
quality.
– It emphasizes that requirements and
specifications translate fitness for use into
measurable quantities.
– Example: Glucometer

Question 19

Quality is conformance to requirements or specifications.

Answer 19

– Gilmore, 1974
– In order to manage quality adequately, we must be able to quantify and measure it.
– Example: Labeled claim of medicines

Question 20

consumer aspect of
quality

Answer 20

Quality is fitness for use.

Question 21

Quality is fitness for use with customer satisfaction

Answer 21

– ISO 9000, 2000
– ISO- International Organization for standardization
* ISO is NOT an acronym.
* Greek word “isos” – “equal”
– Customer satisfaction is the main determinant of quality.
– Example: Quality education

Question 22

ISO

Answer 22

International Organization for standardization

Question 23

“isos”

Answer 23

“equal

Question 24

Customer satisfaction is the main determinant of quality.

Answer 24

Quality is fitness for use with
customer satisfaction

Question 25

Quality is inversely proportional to variability.

Answer 25

– Montgomery, 2013 – If the variability in a product’s important characteristics decreases, the quality of the product increases. – Thus, quality improvement is the reduction of variability in processes and products.

Question 26

If the variability in a product’s important characteristics decreases

Answer 26

the quality of the product increases

Question 26

is the reduction of variability in processes and products.

Answer 26

quality improvement

Question 27

–Every product possesses a number of elements that jointly describe what the user or consumer thinks of as quality.

Answer 27

Quality Characteristics

Question 27

no two products are ever identical (True or False)

Answer 27

True

Question 27

– characteristics that have discrete values and can be counted (Accept/Reject, Pass/Fail, Go/No-Go)

Answer 27

ATTRIBUTES

Question 28

In order to manage quality adequately, we must be able to?

Answer 28

quantify and measure it.

Question 28

– length, weight, diameter, time

Answer 28

VARIABLES

Question 29

– “Measure”

Answer 29

VARIABLES

Question 29

– “Classify

Answer 29

ATTRIBUTES

Question 29

– characteristics that can be measured

Answer 29

VARIABLES

Question 29

– % defective, number of flaws in a shirt, number of broken eggs in a box, etc.

Answer 29

ATTRIBUTES

Question 30

are often evaluated relative to specifications

Answer 30

Quality Characteristics

Question 31

- the desired value for that quality characteristic

Answer 31

Nominal or target value

Question 31

largest allowable value

Answer 31

Upper specification limit (USL)

Question 32

smallest allowable value

Answer 32

Lower specification limit (LSL)

Question 32

fail to meet one or more of its specifications

Answer 32

Nonconforming products

Question 33

can be counted/classified

Answer 33

ATTRIBUTE

Question 34

(a) Either a student PASS or FAIL

Answer 34

ATTRIBUTE

Question 35

(b) Grades: > 70%  PASS < 70%  FAIL

Answer 35

VARIABLE

Question 36

Accept/Reject

Answer 36

ATTRIBUTE

Question 36

can be measured

Answer 36

VARIABLE

Question 36

Length, width

Answer 36

VARIABLE

Question 36

The tablet is 24 mm thick

Answer 36

VARIABLE

Question 37

11 defective products were detected

Answer 37

ATTRIBUTE

Question 38

The weather can be sunny, cloudy, raining, or snowing.

Answer 38

ATTRIBUTE

Question 39

"regulatory process" through which we measure actual quality performance. (Juran, 1974)

Answer 39

Quality Control

Question 40

Reliance on appropriate "analytical tests"

Answer 40

Quality Control

Question 41

Product Oriented

Answer 41

Quality Control

Question 41

Operational techniques

Answer 41

Quality Control

Question 42

l "planned and systematic activities" implemented within the quality system that can be demonstrated "to provide confidence" that a product or service will fulfill requirements for quality

Answer 42

Quality Assurance (QA)

Question 43

Process

Answer 43

Quality Assurance (QA)

Question 44

Applies at all stages of the manufacturing process.

Answer 44

Quality Assurance (QA)

Question 44

Features of QA Systems - inspection/checking

Answer 44

Audit Process

Question 45

Features of QA Systems - purpose and objective

Answer 45

Quality Policy

Question 45

Features of QA Systems - materials, equipment, personnel

Answer 45

Resources

Question 46

Features of QA Systems – procedures and standards

Answer 46

Documentation

Question 46

Benefits of QA

Answer 46

1. higher standards of production, 2. compliance with regulatory requirements, 3. reduced waste, and 4. loss risk of product defects

Question 47

makes sure that quality control is doing what it should be doing.

Answer 47

Quality assurance

Question 48

proactive

Answer 48

Quality assurance

Question 49

audits

Answer 49

Quality assurance

Question 50

focused on process

Answer 50

Quality assurance

Question 51

prevents defects

Answer 51

Quality assurance

Question 52

focused on products

Answer 52

Quality Control

Question 52

finds defects

Answer 52

Quality Control

Question 53

testing

Answer 53

Quality Control

Question 54

reactive

Answer 54

Quality Control

Question 55

Types of Product

Answer 55

1. Raw material 2. In-process material 3. Finish product

Question 55

"Development of strategic activities" designed to improve the quality of a product.

Answer 55

Quality Planning

Question 55

Drugs are special (True or False)

Answer 55

True

Question 56

Manufacturing Process

Answer 56

1. Personnel 2. Premises & Equipment 3. Procedure 4. Product

Question 57

Warehouse (Stickers)

Answer 57

1. Quarantine (Orange) 2. Approved (Green) 3. Rejected (Red)

Question 58

should not induce further harm

Answer 58

drugs

Question 59

Confirms the existence of active ingredient/s

Answer 59

Identity

Question 60

Should not have significant quantities of other products from cross-contamination

Answer 60

Purity

Question 61

Should contain the declared amount of API

Answer 61

Strength or Potency

Question 62

Specified average content range

Answer 62

Strength or Potency

Question 63

OVERAGE - To ensure long shelf-life, products contain with maximum allowable amount – Margin or safety for slight losses over time

Answer 63

Strength or Potency

Question 64

Consistency, colors, shape and sizes should not vary significantly.

Answer 64

Uniformity of Dosage Forms

Question 65

– may suggest problems with quality parameters. –May not reflect safety or efficacy but could influence product acceptability.

Answer 65

Variation

Question 66

Speed and completeness with which a pharmaceutical administered in a specific form enters the bloodstream.

Answer 66

Bioavailability

Question 67

(rate and extent)

Answer 67

Bioavailability

Question 68

Absorption

Answer 68

Bioavailability

Question 69

– Comparative bioavailability

Answer 69

BIOEQUIVALENCE

Question 70

A pharmaceutical product must retain its properties within specified limits

Answer 70

Stability

Question 71

* Expiration Date * Depends on API – Formulation – packaging

Answer 71

Stability

Question 72

– Physical and chemical deterioration – Reduced potency – Formation of toxic by-products

Answer 72

* Improper storage and distribution

Question 72

LADMER

Answer 72

Liberation Absorption Distribution Metabolism Excretion Response

Question 73

Formulation of dosage form

Answer 73

Liberation

Question 74

Absorption

Answer 74

Bioavailability

Question 75

Efficacy to go to the site of action - active

Answer 75

Distribution

Question 75

to inactivate the drug

Answer 75

Metabolism

Question 76

Removed from the body after deactivating the drug

Answer 76

Excretion

Question 76

Pharmacologic Action - activated drug distribution

Answer 76

Response

Question 77

* Starting materials * Manufacturing process * Equipment * Packaging * Storage * Transportation

Answer 77

Pharmaceutical Quality

Question 78

* Where quality standards are "published periodically" * Provide detailed descriptions of pharmaceutical "characteristics and analytical techniques."

Answer 78

Pharmacopeias

Question 79

– Major manufacturing and exporting countries in EU

Answer 79

* European Pharmacopeia

Question 80

Includes monographs on finished dosage forms

Answer 80

* WHO International Pharmacopeia

Question 80

Qualitative test

Answer 80

Identification

Question 81

– Complex and expensive analytical procedures

Answer 81

* United States Pharmacopeia

Question 81

Provides "detailed parameters" that are used to determine whether a medicine meets key quality attributes 1. the name of the ingredient or preparation; 2. the definition; 3. packaging, storage, and labeling requirements; and 4. the specification.

Answer 81

Pharmacopeial Monograph

Question 82

Quantitative test

Answer 82

Assay

Question 82

Contaminants in trace amounts

Answer 82

Impurities

Question 83

NMT

Answer 83

Not more than

Question 84

NLT

Answer 84

Not less than

Question 85

To ensure that each medicine reaching a patient is –SAFE –EFFECTIVE, and of –ACCEPTABLE QUALITY

Answer 85

Pharmaceutical QA

Question 86

* Toxicity or ADRs * Prolonged illness * Death * Wastes money * Affect health system credibility

Answer 86

Consequences of Poor Quality Pharmaceuticals

Question 87

Most counterfeiting cases occur in less developed and developing countries, where poverty and loose regulatory oversight make marketing counterfeits easier.

Answer 87

Prevalence of Poor Quality Pharmaceuticals