PRELIM: 2

Question 1

is essential in the pharmaceutical industry to ensure drugs are safe, effective, and consistent.

Answer 1

Quality control

Question 2

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

Answer 2

Juran’s Definition

Question 3

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

Answer 3

Broom’s Definition

Question 4

Techniques to manufacture products of uniform acceptable quality.

Answer 4

Alford and Beatty’s Definition

Question 5

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

Answer 5

Quality Control

Question 6

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

Answer 6

Quality Assurance

Question 7

Role of Quality Control in
Pharmaceuticals

Answer 7

Ensure Safety and Efficacy
Keep Pace with Advances
Key Responsibilities

Question 8

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

Answer 8

Ensure Safety and Efficacy

Question 9

Evaluate new medicinal agents using sophisticated analytical methods.

Answer 9

Keep Pace with Advances

Question 10

Efficacy, safety, quality, and compliance.

Answer 10

Key Responsibilities

Question 11

Quality Control Areas in Pharmaceuticals

Answer 11

Raw Materials and API
Packaging Components
Finished Products

Question 12

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

Answer 12

Raw Materials and API

Question 13

Tests: Appearance, spectroscopy, loss on
drying

Answer 13

Packaging Components

Question 14

Techniques: HPLC, assay, dissolution,
content uniformity

Answer 14

Finished Products

Question 14

Control Measures (4)

Answer 14

Material control
Manufacturing practice control
Packaging control
Distribution control

Question 14

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

Answer 14

Quality Variation

Question 14

Material Control

Answer 14

Reception and Testing
Documentation
Storage and Labeling

Question 14

Maintain complete records of all procedures and tests

Answer 14

Documentation

Question 14

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

Answer 14

Reception and Testing

Question 15

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

Answer 15

Storage and Labeling

Question 16

Manufacturing Practices Control (3)

Answer 16

Personnel
Equipment and Building
Record Control

Question 17

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

Answer 17

Personnel

Question 17

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

Answer 17

Equipment and Building

Question 17

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

Answer 17

Record Control

Question 18

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

Answer 18

Packaging Control

Question 19

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

Answer 19

Distribution Control

Question 20

Objectives of Quality Control (3)

Answer 20

Establish Quality Standards Locate Quality Deviations Evaluate Production Methods

Question 21

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

Answer 21

Establish Quality Standards

Question 22

Analyze trends and extent of quality deviations using statistical techniques.

Answer 22

Locate Quality Deviations

Question 23

Implement corrective measures to maintain quality.

Answer 23

Evaluate Production Methods

Question 24

Accelerate sales by supplying only quality goods.

Answer 24

Quick Sale of Quality Goods

Question 25

Manufacture standard quality products and avoid inferior quality.

Answer 25

Produce Standard Quality Goods

Question 26

Create quality consciousness at all organizational levels.

Answer 26

Improve Quality

Question 27

Steps in Quality Control

Answer 27

Control Raw Materials Set Standards and Specifications Control Production Operations Locate Inspection Points Maintain Equipment Quality Maintain Records

Question 27

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

Answer 27

Control Raw Materials

Question 28

Predetermine standards and specifications for successful quality control.

Answer 28

Set Standards and Specifications

Question 29

Investigate operating methods to execute efficient practices.

Answer 29

Control Production Operations

Question 30

Investigate operating methods to execute efficient practices.

Answer 30

Locate Inspection Points

Question 31

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

Answer 31

Maintain Equipment Quality

Question 32

Keep records related to quality inspection, control, and rejections

Answer 32

Maintain Records

Question 32

Quality planning, training, process control

Answer 32

Prevention Costs

Question 32

Inspection, testing, quality audits

Answer 32

Appraisal Costs

Question 32

Scrap, rework, re-inspection

Answer 32

Internal Failure Costs

Question 33

Complaints, returns, warranty claims

Answer 33

External Failure Costs

Question 34

A process designed to focus on customer expectations, prevent problems, build commitment to quality, and promote open decision making

Answer 34

Total Quality Management (TQM)

Question 35

Principles of TQM

Answer 35

Customer Focus Employee Involvement Continuous Improvement Management Commitment

Question 35

A small group of volunteers doing similar work, meeting regularly to identify problems, set priorities, discover causes, and propose solutions. Focus Areas: Quality, productivity, safety, job structure, and process flow

Answer 35

Quality Circle

Question 35

Recognize that customer needs and business goals are inseparable.

Answer 35

Customer Focus

Question 35

Encourage participation and cooperation at all levels.

Answer 35

Employee Involvement

Question 35

Never-ending quest for achieving new levels of performance.

Answer 35

Continuous Improvement

Question 36

Requires total commitment from top management for viable leadership

Answer 36

Management Commitment