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midterm ! Flashcards

1
Q

a leadership and management philosophy and guiding principles stressing continuous improvement through people involvement and quantitative methods focusing on total customer satisfaction

A

TQM

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2
Q

this set the requirements for quality and can make or break an organization

A

customer focus

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3
Q

one who purchases or uses the product or service or one who influences the sale of the product or service

A

external customer

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4
Q

TRUE OR FALSE

every person in a production process is considered a customer of the preceding operation

A

true

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5
Q

3 categories of an external customer

A
  1. current
  2. prospective
  3. lost
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6
Q

their goal is to make sure that the quality meets the expectations of the next person

A

internal customer

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7
Q

is about collective insight in customer needs, wants, perceptions, and preferences gained through direct and indirect questioning

A

voice of the customer

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8
Q

is a summary of all needs related to a business and its stakeholders, including profitability, revenue, growth, and market share

A

voice of the business

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9
Q

refers to the performance and capability of a process to perform in relation to both customer and business needs

A

voice of the process

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10
Q

takes measure to eliminate discrepancies between customer’s expectations and satisfaction

A

gap analysis

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11
Q

can help determine discrepancies between expectations and satisfaction

A

customer survey

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12
Q

documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose

A

quality standard

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13
Q

ISO 9000, ISO 9001

A

quality management

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14
Q

ISO 19011

A

auditing

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15
Q

ISO 14000, ISO 14001

A

environmental management

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16
Q

ISO 31000

A

risk management

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17
Q

ISO 26000

A

social responsibility

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18
Q

ISO Zt. 9

A

sampling by variables

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19
Q

ISO Zt. 4

A

sampling by attributes

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20
Q

ISO 22000

A

food safety

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21
Q

is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop guidelines

A

ICH

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22
Q

promotes public health through international harmonization

A

ICH

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23
Q

TRUE OR FALSE

clinical trials conducted in one ICH region can be used in other ICH regions

Good Clinical Practice (GCP)

A

true

by setting the common standards on science and ethics

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24
Q

brings together all quality, safety, efficacy information in a common, harmonized format, accepted by regulators in all ICH regions

A

Common Technical Document

CTD or eCTD

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25
Q

it has revolutionized regulatory review process for regulators and industry

A

Common Technical Document

CTD or eCTD

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26
Q

highly specific, standardized medical terminology developed by the ICH to facilitate sharing of regulatory information

A

Medical Dictionary for Regulatory Activities

MedDRA

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27
Q

used for registration, documentation, and safety monitoring of medical products both before and after the marketing authorization

A

Medical Dictionary for Regulatory Activities

MedDRA

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28
Q

ICH

how many safety guidelines are there?

A

15

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29
Q

ICH

how many quality guidelines are there?

A

24

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30
Q

ICH

how many efficacy guidelines are there?

A

21

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31
Q

ICH

how many multidisciplinary guidelines are there?

A

7

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32
Q

an act to ensure the safety and purity of foods and cosmetics and the purity, safety, efficacy, and quality of drugs and devices being made available to the public

A

R.A. 3720

Foods, Drugs and Devices, and Cosmetics Act

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33
Q

an acts strengthening and rationalizing the regulatory capacity of the Bureau of Food and Drugs (BFAD), and renaming it the Food and Drug Administration (FDA)

A

R.A. 9711

Food and Drug Administration (FDA) Act of 2009

34
Q

guidelines on the unified licensing requirements and procedures of the FDA

A

AO no. 2016-0003

35
Q

this states that drugs must undergo current good manufacturing practice in manufacture, processing, packing or holding

A

AO 220 s. 1974

36
Q

this order prescribes the conditions and requirements for good manufacturing practice applied to premises, equipment, personnel, product and warehousing

A

AO 220 s. 1974

37
Q

is defined as a formalized system that documents processes, procedures, and responsibilites for achieving quality policies and objectives

A

Quality Management System

QMS

38
Q

helps coordinate and direct an organization’s activities to meet the customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis

A

Quality Management System

QMS

39
Q

principles of quality management system

A
  1. customer focus
  2. leadership
  3. engagement of people
  4. process approach
  5. improvement
  6. evidence-based decision making
  7. relationship management
40
Q

the primary focus of the quality management

A

to meet the customer requirements

41
Q

are based on seven quality management principles that senior management can apply for organizational improvements

A

ISO 9000:2015, ISO 9001:2015

42
Q

competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value

A

engagement of people

43
Q

consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system

A

process approach

44
Q

decisions based on the analysis and evaluation of data and information

A

evidence-based decision making

45
Q

for sustained success, an organization manages its relationships with interested parties, such as suppliers

A

relationship management

46
Q

examples of interested parties or stakeholders

A
  • customers
  • employees
  • vendors
  • regulatory agencies
47
Q

the QMS should be influenced by:

A
  • organization’s varying objectives
  • needs
  • products
  • services provided
48
Q

is a four-step model for carrying out change

A

plan-do-check-act

PDCA

49
Q

steps on PDCA

A
  1. plan (P)
  2. perform (D)
  3. monitor (C)
  4. improve (A)
50
Q

steps in implementing quality management design

A
  1. design
  2. build
  3. deploy
  4. control
  5. measure
  6. review
  7. improve
51
Q

serve to develop the structure of a QMS, its processes, and plans for implementation

A

design and build

52
Q
  • breaking each process down into subprocesses
  • educating staff on documentation, education, training tools, and metrics
  • to assist in the deployment of quality management systems
A

deploy

53
Q

are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system

A

control and measure

54
Q

is defined as the on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements

A

auditing

55
Q
  • detail how the results of an audit are handled
  • goals are to determine the effectiveness and efficiency of each process toward its objectives
  • to communicate these findings to the employees
  • to develop new best practices and processes based on the data collected during the audit
A

review and improve

56
Q

a series of QMS standards that provide guidance and tools for companies and organizations to ensure that their products and services consistently meet customer’s requirements for consistent improvement in quality

A

ISO 9000

57
Q

this specifies the fundamentals and vocabulary used in all these ISO 9000 standards

A

ISO 9000:2015

58
Q

this is the requirement standard that provides directions on how to achieve quality requirements

A

ISO 9001:2015

59
Q

is the only auditable standard for which third party certification and auditing organizations provide independent confirmation that the requirements of that standard are met

A

ISO 9001

60
Q

procedures employed to ensure that the drug product or substance is manufactured under a quality management system and meets the claimed requirements for purity, identity, safety, and quality

A

Good Manufacturing Practice

GMP

61
Q

continuously evolving feasible and valuable industry practices

A

Good Manufacturing Practices

GMP

62
Q

part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use

A

Good Manufacturing Practices

GMP

63
Q

TRUE OR FALSE

product testing is a reliable way to assure product quality

A

false

not a reliable way

64
Q

TRUE OR FALSE

production and quality control functions should be dependent of each other

A

false

independent of each other

65
Q

TRUE OR FALSE

rejected materials should be returned to the suppliers or to be destroyed

A

true

66
Q

TRUE OR FALSE

all waste materials should be stored properly and in a safe place

A

true

67
Q

part of GMP that is concerned with sampling, specification, and testing

A

quality control

68
Q

TRUE OR FALSE

quality control should be independent from production and other departments

A

true

69
Q

items concerned in quality control

A
  • starting materials
  • packaging materials
  • bulk products
  • intermediate and finished products
  • environmental conditions
70
Q

a reliable evidence for GMP compliance which establish, monitor, and record quality for all aspects of the production, quality control and quality assurance

A

documentation

71
Q

its objective is to provide understanding regarding general requirements of the personnel in pharmaceutical manufacturing facilities

A

personnel

72
Q

its objective is to be able to disseminate the information on the organization structure

A

personnel

73
Q

what is the number 1 source of contaminants?

A

people

74
Q

this aim to eliminate all potential sources of contamination and cross-contamination from all areas where the product quality is at risk

A

sanitation and hygiene

75
Q

should be practiced to avoid contamination from personnel during the manufacture of products

A

sanitation and hygiene

76
Q

shall be performed in a manner to prevent contamination of materials and products

A

cleaning operations

77
Q

division of cleaning practices

A
  1. deep cleaning
  2. housekeeping cleaning
  3. maintenance cleaning
78
Q

design of the appropriate clean attire should not have the following

A
  • fiber materials
  • pocket at upper part of the waist
79
Q

TRUE OR FALSE

personal items such as pens, pencils, or thermometers shall be carried in pockets or pouches below the waist when employees are in production areas

A

true

80
Q

TRUE OR FALSE

cleaning and sanitation alone can assure a hygienic standard in production

A

false

cannot assure; process and personal hygiene are also important

81
Q

examples of sanitary facilities

A
  • water supply
  • plumbing
  • toilet facilities
  • handwashing facilities
  • rubbish disposal
  • changing facility or locker

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