General

Question 1

3 Quality Gurus

Answer 1

Dr. Joseph Duran
Dr. Edward Deming
Philip Crosby

Question 2

1911

Answer 2

Principles of scientific management - First framework for quality in industrial organisations
Frederick Winslow Taylor

Question 3

1920

Answer 3

Manufacturing organisations began to adopt statistical methods for quality

Question 4

1940/50

Answer 4

refined in Japan Deming, Juran

Question 5

1980s

Answer 5

TQM global organisations began adopting quality intitiatives modeled after successful programs in Japan

Question 6

What is Total Quality Management?

Answer 6

A management strategy aimed at embedding awareness of quality in all organisational processes

Question 7

What are the 8 principles of TQM?

Answer 7

1. Customer Focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach
6. Continual improvement
7. Factual approach to decision making
8. Supplier relationships

CLIPS CFS

Question 8

What is ICH10?

Answer 8

A guideline that provides standardized procedures for the management and reporting of safety data in clinical trials and post-marketing surveillance of drugs.
Outlines requirements for the reporting of serious adverse events, provides guidance on the identification and management of safety signals, and emphasizes the importance of consistent and timely reporting of safety data across all regions of the world.
The ultimate goal of ICH10 is to ensure the protection of clinical trial participants and patients receiving marketed drugs from harm.

Question 9

GMP

Answer 9

Good Manufacturing Practices
A set of regulation and guidelines that define the minimum requirements for the manufacture of pharma products.

Question 10

GCP

Answer 10

Good Clinical Practices
* A set of international ethical and scientific quality standards for the design, conduct, recording and reporting of clincial trials involving human subjects.
* Compliance is mandatory to ensure trial subjects are protected.

Question 11

GLP

Answer 11

Good Laboratory Practices
Set of standards and guidelines for the organisational process of non-clinical laboratory studies

Question 12

GTP

Answer 12

Good Tissue Practice
Set of regulations and guidelines that define minimum requirements for production and distribution of human cells, tissues and cellular and tissue based products intended for transplantation

Question 13

GDP

Answer 13

Good Distribution Practice
* Set of guideliens and standards that describe the requirements for the proper distribution of pharmaceutical products.
* Compliance is mandatory

Question 14

Differences between GMP and ISO

Answer 14

GMP
* Mandatory
* Specific to pharma
* Standards rely on testing and inspection
* Ensures public safety
* Monitored by FDA

ISO
* Voluntary
* Applied to any industry
* Standars rely on management commitment
* Satisfy commercial or customer expectations
* Monitored by outside auditors

Question 15

Similarities between GMP and ISO

Answer 15

Both require:
* Establishment and maintenance of QMS
* Creation and maintenance of documentation
* Personnel to be trained and qualified
* Validation of processes & systems used
* Use of a continuous improvement process

Question 16

Differences between GMP testing & GLP testing

Answer 16

GMP testing
* Used to ensure the quality and safety of pharma products
* Focuses on manufacturing and testing
GLP testing
* Used to generate data to support regulatory submission for non-clinical laboratory studies
* Focuses on laboratory procedures and protocols

Question 17

Documentation used in GMP

Answer 17

• Batch Records
• Standard Operating Procedures (SOPs)

Question 18

Batch Records

Answer 18

• Used to record complete manufacturing history of a single batch of a pharmaceutical product.
• Provides a detailed account of the steps involved in the manufacture of a product including materials, equipment and facilities used.
• Important for ensuring quality and consistency
• Can be used to identify source of problem in the case of any issues

Question 19

Standard operating procedures (SOPs)

Answer 19

• Describe the standard methods and procedures that must be followed during the manufacturing process
• Provide clear instructions on each step of the process including the equipment and materials required
• Essential for ensuring consistency and uniformity in manufacturing process as they provide a standardisation approach that is reliable
• Critical for the ensuring of product consistency, identifying & correcting issues, and training personnel