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Manufacture Lab > CGMP > Flashcards

CGMP Flashcards

1
Q

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

A

Reinvent themselves

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2
Q

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

A

Excellent execution

Long-term success

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3
Q

Due to increased SCRUTINY and HIGHER SAFETY STANDARDS

A
  1. Decline in the number of new chemical entities (NCEs)
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4
Q

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

A

Increased Generic Competition

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5
Q

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

A

Regulatory changes

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6
Q

Done to demonstrate the VALUE they bring to patients and stakeholders

A

Regulatory changes

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7
Q

Common problems faced by pharmaceutical companies

A
  1. Decline in the number of new chemical entities
  2. Increased Generic Competition
  3. Regulatory changes
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8
Q

Potential significant sources of economic, developmental and drug market growth

A 
E7 countries or non industrialized countries 
China
India
Brazil
Russia
Turkey
South Korea
Poland
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9
Q

Having significant business activities OTHER THAN the traditional pharmaceutical arena

A

Diversification

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10
Q

Integrate _________ in all aspects of drug manufacture

A

Quality

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11
Q

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

A

Low risk of failing

Clinical attributes

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12
Q

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

A

Quality before

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13
Q

Quality before is

A

Conformance to requirements and specifications

Fitness of purpose

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14
Q

Focus of quality before

A

Compliance-centered

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15
Q

Quality now is a predictable degree of

A

Uniformity
Dependability
Low cost
Suitability

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16
Q

Focus of quality now

A

Patient-centered

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17
Q

PLANNED SYSTEM of activities to ensure effective quality control

A

Quality assurance

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18
Q

It involves ALL aspects of manufacturing

A

Quality assurance

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19
Q

Quality assurance aims to push all practices which will produce

A

Highest purity, consistency and quality

20
Q

Quality assurance aims to produce

A

Compliant
Safe
Suitable
Affordable

21
Q

Made while FOLLOWING REQUIREMENTS

A

Compliance

22
Q

Microbiology issues on sterility

Freedom from pathogens

A

Safety

23
Q

Integrates QUALITY of raw materials

A

Suitability

24
Q

Reasonably PRICED and AVAILABLE for all

A

Affordable

25
Q

Planned COHERENT system of activities

A

Quality control

26
Q

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

A

CGMP

27
Q

Scope of CGMP

A

Starting materials to personal hygiene of staff

28
Q

Evidence of CGMP

A

Documented proof that procedures were followed

29
Q

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

A

Total quality management system (TQMS)

30
Q

TQMS uses a motion of

A

Culture
Communication
Commitment

31
Q

Tools needed in TQMS

A

Flowcharts
Check sheets
Control charts

32
Q

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

A

Quality mantra

33
Q

Revolution in quality thinking

A

Testing and inspection
Quality control
Quality assurance
Total quality management systems

34
Q

GMPs tell you ____________

SOPs tell you _____________

A

What to do

How to do it

35
Q

CGMP eliminates

A

100% Destructive testing

36
Q

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

A

QC unit

37
Q

Personnel qualifications of organization and personnel

A

Education
Training
Experience

38
Q

Building facilities need

A

Ventilation
Air filtration
Air heating
Cooling

39
Q

Equipment should facilitate operations for its

A

Intended use
Cleaning
Maintenance

40
Q

Drug product containers and closures shall

A

Not be reactive, additive or absorptive
Provide adequate protection
Clean

41
Q

It should be established and followed

A

Written procedures

42
Q

Special testing requirements

A

Sterile or pyrogen-free
Ophthalmic
Controlled release

43
Q

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

A

1 year

3 years

44
Q

Routine procedure of GENERAL USE

A

Standard operating procedure

45
Q

Procedure for the preparation of a SPECIFIC PRODUCT

A

Master production and control record (MPCR)

46
Q

EXACT COPY of the approved MPCR

A

Batch production and control record (BPCR)

Manufacture Lab (2 decks)

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