CGMP

Question 1

Many industries are faced with a common phenomenon forcing them to ____________ ________________ in the face of challenges

Answer 1

Reinvent themselves

Question 2

Only companies that are willing to change or modify their strategies followed by _______________ _______________ will have ___________________

Answer 2

Excellent execution

Long-term success

Question 3

Due to increased SCRUTINY and HIGHER SAFETY STANDARDS

Answer 3

1. Decline in the number of new chemical entities (NCEs)

Question 4

At the end of patents, generic drug makes UNDERCUT the profit margin

Answer 4

Increased Generic Competition

Question 5

Driven by the need to improve the regulatory process to meet CURRENT EXPECTATIONS

Answer 5

Regulatory changes

Question 6

Done to demonstrate the VALUE they bring to patients and stakeholders

Answer 6

Regulatory changes

Question 7

Common problems faced by pharmaceutical companies

Answer 7

1. Decline in the number of new chemical entities
2. Increased Generic Competition
3. Regulatory changes

Question 8

Potential significant sources of economic, developmental and drug market growth

Answer 8

E7 countries or non industrialized countries 
China
India
Brazil
Russia
Turkey
South Korea
Poland

Question 9

Having significant business activities OTHER THAN the traditional pharmaceutical arena

Answer 9

Diversification

Question 10

Integrate _________ in all aspects of drug manufacture

Answer 10

Quality

Question 11

Good pharmaceutical quality represents ____________________ to achieve the desired ________________ for the sake of patients

Answer 11

Low risk of failing

Clinical attributes

Question 12

It is the TOTAL of the features and characteristics of a product to SATISFY a given need

Answer 12

Quality before

Question 13

Quality before is

Answer 13

Conformance to requirements and specifications

Fitness of purpose

Question 14

Focus of quality before

Answer 14

Compliance-centered

Question 15

Quality now is a predictable degree of

Answer 15

Uniformity
Dependability
Low cost
Suitability

Question 16

Focus of quality now

Answer 16

Patient-centered

Question 17

PLANNED SYSTEM of activities to ensure effective quality control

Answer 17

Quality assurance

Question 18

It involves ALL aspects of manufacturing

Answer 18

Quality assurance

Question 19

Quality assurance aims to push all practices which will produce

Answer 19

Highest purity, consistency and quality

Question 20

Quality assurance aims to produce

Answer 20

Compliant
Safe
Suitable
Affordable

Question 21

Made while FOLLOWING REQUIREMENTS

Answer 21

Compliance

Question 22

Microbiology issues on sterility

Freedom from pathogens

Answer 22

Safety

Question 23

Integrates QUALITY of raw materials

Answer 23

Suitability

Question 24

Reasonably PRICED and AVAILABLE for all

Answer 24

Affordable

Question 25

Planned COHERENT system of activities

Answer 25

Quality control

Question 26

A part of QA assumed to ensure products are CONSISTENTLY manufactured at quality level

Answer 26

CGMP

Question 27

Scope of CGMP

Answer 27

Starting materials to personal hygiene of staff

Question 28

Evidence of CGMP

Answer 28

Documented proof that procedures were followed

Question 29

From a complex process of industrial SELF-AUDITING and SELF-INSPECTION

Answer 29

Total quality management system (TQMS)

Question 30

TQMS uses a motion of

Answer 30

Culture Communication Commitment

Question 31

Tools needed in TQMS

Answer 31

Flowcharts Check sheets Control charts

Question 32

Quality cannot be tested into products; it has to be BUILT BY DESIGN

Answer 32

Quality mantra

Question 33

Revolution in quality thinking

Answer 33

Testing and inspection Quality control Quality assurance Total quality management systems

Question 34

GMPs tell you ____________ | SOPs tell you _____________

Answer 34

What to do | How to do it

Question 35

CGMP eliminates

Answer 35

100% Destructive testing

Question 36

In organization and personnel, there shall be ______________ that shall approve or reject batches

Answer 36

QC unit

Question 37

Personnel qualifications of organization and personnel

Answer 37

Education Training Experience

Question 38

Building facilities need

Answer 38

Ventilation Air filtration Air heating Cooling

Question 39

Equipment should facilitate operations for its

Answer 39

Intended use Cleaning Maintenance

Question 40

Drug product containers and closures shall

Answer 40

Not be reactive, additive or absorptive Provide adequate protection Clean

Question 41

It should be established and followed

Answer 41

Written procedures

Question 42

Special testing requirements

Answer 42

Sterile or pyrogen-free Ophthalmic Controlled release

Question 43

Written records shall be retained for at least _________ after expiration date or ___________ after distribution.

Answer 43

1 year | 3 years

Question 44

Routine procedure of GENERAL USE

Answer 44

Standard operating procedure

Question 45

Procedure for the preparation of a SPECIFIC PRODUCT

Answer 45

Master production and control record (MPCR)

Question 46

EXACT COPY of the approved MPCR

Answer 46

Batch production and control record (BPCR)