Quality control measures

Question 1

Quality is fitness for purpose
or use. It refers to features
and characteristics that
satisfy consumer needs.

Answer 1

Juran’s Definition

Question 2

Systematic control of
variables in manufacturing
that affect end product
excellence.

Answer 2

Broom’s Definition

Question 3

Techniques to manufacture products of uniform acceptable
quality.

Answer 3

Alford and Beatty’s Definition

Question 4

____focused on preventing defects by
improving development processes. Aims to improve
processes so defects don’t arise during product development. (QA)

Answer 4

proactive process

Question 5

Proactive process focused on preventing defects by
improving development processes. Aims to improve
processes so defects don’t arise during product development.

Answer 5

quality assurance

Question 6

____focused on identifying defects in finished
products before release. Aims to find and correct defects
after development but before release. (QC)

Answer 6

reactive process

Question 7

Reactive process focused on identifying defects in finished
products before release. Aims to find and correct defects
after development but before release.

Answer 7

quality control

Question 8

role of QC in pharmaceuticals

Answer 8

Ensure Safety and
Efficacy, Keep Pace with
Advances, Key Responsibilities

Question 9

Drugs must be safe and
therapeutically active with
consistent, predictable
performance.

Answer 9

Ensure Safety and
Efficacy

Question 10

Evaluate new medicinal
agents using sophisticated
analytical methods.

Answer 10

keep pace with advances

Question 11

Efficacy, safety, quality, and compliance.

Answer 11

key responsibilities

Question 12

Quality Control Areas in
Pharmaceuticals

Answer 12

Raw Materials and API, Packaging Components, Finished Products

Question 13

Techniques: Raman/IR spectroscopy, HPLC
assay, physical tests

Answer 13

raw materials and API

Question 14

Tests: Appearance, spectroscopy, loss on
drying

Answer 14

Packaging components

Question 15

Techniques: HPLC, assay, dissolution,
content uniformity

Answer 15

finished products

Question 16

Errors can occur at any stage from raw material reception to
final packaging. Risk increases with more materials and
complex methods.

Answer 16

quality variation

Question 17

control measures?

Answer 17

Material control
Manufacturing practice control
Packaging control
Distribution control

Question 18

Establish systems for
receiving, testing, and
storing all supplies including
drug substances, excipients,
and packaging materials.

Answer 18

reception and testing (MC)

Question 19

Maintain complete records
of all procedures and tests.

Answer 19

Documentation (MC)

Question 20

Properly store and label materials, conduct laboratory testing, and
mark as “Passed” or “Rejected”.

Answer 20

Storage and labeling (MC)

Question 21

Properly educated and trained
staff in all departments. Regular
training and supervision.

Answer 21

personnel (MPC)

Question 22

Suitable design, size, construction,
and location. Non-reactive, easy to
clean and operate.

Answer 22

Equipment and building (MPC)

Question 23

Maintain master formula records
and batch production records for
each product and batch.

Answer 23

Record control (MPC)

Question 24

Use recommended containers, ensure correct labeling and
batch numbers. Select packaging material based on product
nature and distribution.

Answer 24

packaging control

Question 25

Keep samples of each batch in record for years. Examine or test material for any necessary demand or purpose.

Answer 25

distribution control

Question 26

Objectives of Quality Control

Answer 26

Establish Quality Standards, Locate Quality Deviations, Evaluate Production Methods

Question 27

Economical production of high-quality products at customer-desired levels.

Answer 27

Establish Quality Standards

Question 28

Implement corrective measures to maintain quality.

Answer 28

Evaluate Production Methods

Question 29

Analyze trends and extent of quality deviations using statistical techniques.

Answer 29

Locate Quality Deviations

Question 30

More Objectives of Quality Control

Answer 30

Quick Sale of Quality Goods, Produce Standard Quality Goods, Improve Quality

Question 31

Accelerate sales by supplying only quality goods.

Answer 31

Quick Sale of Quality Goods

Question 32

Manufacture standard quality products and avoid inferior quality.

Answer 32

Produce Standard Quality Goods

Question 33

Create quality consciousness at all organizational levels.

Answer 33

Improve Quality

Question 34

Steps in Quality Control

Answer 34

control raw materials, Set Standards and Specifications, Control Production Operations

Question 35

Ensure quality of raw materials as they largely determine finished product quality.

Answer 35

Control Raw Materials

Question 36

Predetermine standards and specifications for successful quality control.

Answer 36

Set Standards and Specifications

Question 37

Investigate operating methods to execute efficient practices.

Answer 37

Control Production Operations

Question 38

More Steps in Quality Control

Answer 38

Locate Inspection Points, Maintain Equipment Quality, Maintain Records

Question 39

Properly locate points where defects occur to avoid hindering quality control.

Answer 39

Locate Inspection Points

Question 40

Ensure quality of equipment and devices used as they affect final product quality.

Answer 40

Maintain Equipment Quality

Question 41

Keep records related to quality inspection, control, and rejections.

Answer 41

maintain records

Question 42

Advantages of Quality Control

Answer 42

Improved Quality and Cost Reduction, Uniformity and Customer Satisfaction, Reduced Rejections and Increased Exports

Question 43

cost of quality

Answer 43

Prevention Costs - Quality planning, training, process control Appraisal Costs - inspection, testing, quality audits Internal Failure Costs - Scrap, rework, re-inspection External Failure Costs - complaints, returns, warranty claims

Question 44

Total Quality management (TQM)

Answer 44

A process designed to focus on customer expectations, prevent problems, build commitment to quality, and promote open decision- making. Not restricted to goods and services, but applies to all aspects of management. Requires cooperation and involvement from all employees for maintaining efficiency.

Question 45

why TQM is needed?

Answer 45

Customer Satisfaction-Focus on meeting and exceeding consumer expectations. Competitive Edge-Face market competition effectively and create goodwill. Employee Motivation-provide better facilities, training, and participation in decision-making. Industrial Growth-Facilitate economic progress and prosperity for the nation.

Question 46

principles of TQM

Answer 46

Customer Focus-Recognize that customer needs and business goals are inseparable. Continuous Improvement-Never-ending quest for achieving new levels of performance. Employee Involvement-Encourage participation and cooperation at all levels. Management Commitment-Requires total commitment from top management for viable leadership.

Question 47

Quality circle

Answer 47

A small group of volunteers doing similar work, meeting regularly to identify problems, set priorities, discover causes, and propose solutions. Quality, productivity, safety, job structure, and process flow. A form of participative management, human resource development, and problem-solving technique.

Question 48

Advantages of Quality Circle

Answer 48

Productivity and Quality-Promotes productivity and quality mindedness, reduces waste and costs. Employee Development-Increases motivation, job satisfaction, and sense of belongingness. Develops leadership skills. Organizational Benefits-improves communication, creates team spirit, and increases human resource potential.