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midterm ! Flashcards

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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
it has **revolutionized regulatory review** process for regulators and industry
Common Technical Document | **CTD or eCTD**
26
highly specific, standardized **medical terminology** *developed by the ICH* to facilitate sharing of regulatory information
Medical Dictionary for Regulatory Activities | **MedDRA**
27
used for registration, documentation, and safety monitoring of medical products both before and after the marketing authorization
Medical Dictionary for Regulatory Activities | **MedDRA**
28
# ICH how many safety guidelines are there?
15
29
# ICH how many quality guidelines are there?
24
30
# ICH how many efficacy guidelines are there?
21
31
# ICH how many multidisciplinary guidelines are there?
7
32
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
R.A. 3720 | Foods, Drugs and Devices, and Cosmetics Act
33
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)**
R.A. 9711 | Food and Drug Administration (FDA) Act of 2009
34
**guidelines on the unified** licensing requirements and procedures of the FDA
AO no. 2016-0003
35
this states that drugs must undergo **current good manufacturing practice** in manufacture, processing, packing or holding
AO 220 s. 1974
36
this order prescribes the conditions and requirements for **good manufacturing practice** applied to premises, equipment, personnel, product and warehousing
AO 220 s. 1974
37
is defined as a **formalized system** that documents processes, procedures, and responsibilites for achieving quality policies and objectives
Quality Management System | **QMS**
38
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
Quality Management System | **QMS**
39
principles of quality management system
1. customer focus 2. leadership 3. engagement of people 4. process approach 5. improvement 6. evidence-based decision making 7. relationship management
40
the **primary focus** of the quality management
to meet the customer requirements
41
are **based on seven quality management principles** that senior management can apply for organizational improvements
ISO 9000:2015, ISO 9001:2015
42
competent, empowered and **engaged people** at all levels throughout the organization are essential to enhance its capability to create and deliver value
engagement of people
43
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
process approach
44
**decisions based on the analysis and evaluation** of data and information
evidence-based decision making
45
for sustained success, an organization manages its **relationships with interested parties**, such as suppliers
relationship management
46
examples of interested parties or stakeholders
* customers * employees * vendors * regulatory agencies
47
the QMS should be influenced by:
* organization's varying objectives * needs * products * services provided
48
is a four-step model **for carrying out change**
plan-do-check-act | **PDCA**
49
steps on PDCA
1. plan (P) 2. perform (D) 3. monitor (C) 4. improve (A)
50
steps in implementing quality management design
1. design 2. build 3. deploy 4. control 5. measure 6. review 7. improve
51
serve to **develop the structure** of a QMS, its processes, and plans for implementation
design and build
52
* breaking each process down into **subprocesses** * **educating staff** on documentation, education, training tools, and metrics * to **assist in the deployment** of quality management systems
deploy
53
are two areas of establishing a QMS that are **largely accomplished through routine**, systematic audits of the quality management system
control and measure
54
is defined as the **on-site verification activity**, such as inspection or examination, of a process or quality system, to ensure compliance to requirements
auditing
55
* 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
review and improve
56
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
ISO 9000
57
this **specifies the fundamentals and vocabulary** used in all these ISO 9000 standards
ISO 9000:2015
58
this is the requirement standard that **provides directions** on how to achieve quality requirements
ISO 9001:2015
59
is **the only auditable standard** for which third party certification and auditing organizations provide independent confirmation that the requirements of that standard are met
ISO 9001
60
**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
Good Manufacturing Practice | **GMP**
61
continuously evolving **feasible and valuable** industry practices
Good Manufacturing Practices | **GMP**
62
**part of quality assurance** which ensures that products are **consistently produced and controlled** to the quality standards appropriate to their intended use
Good Manufacturing Practices | **GMP**
63
# TRUE OR FALSE product testing is a **reliable way** to assure product quality
false | not a reliable way
64
# TRUE OR FALSE production and quality control functions should be **dependent** of each other
false | independent of each other
65
# TRUE OR FALSE **rejected materials** should be returned to the suppliers or to be destroyed
true
66
# TRUE OR FALSE all **waste materials** should be **stored properly** and in a safe place
true
67
part of GMP that is concerned with **sampling, specification, and testing**
quality control
68
# TRUE OR FALSE quality control should be **independent** from production and other departments
true
69
items concerned in quality control
* starting materials * packaging materials * bulk products * intermediate and finished products * environmental conditions
70
a **reliable evidence for GMP** compliance which establish, monitor, and record quality for all aspects of the production, quality control and quality assurance
documentation
71
its objective is to **provide understanding** regarding general requirements of the personnel in pharmaceutical manufacturing facilities
personnel
72
its objective is to be able to **disseminate the information** on the organization structure
personnel
73
what is the number 1 source of contaminants?
people
74
this aim to **eliminate** all potential **sources of contamination and cross-contamination** from all areas where the product quality is at risk
sanitation and hygiene
75
should be practiced **to avoid contamination from personnel** during the manufacture of products
sanitation and hygiene
76
shall be **performed** in a manner **to prevent contamination** of materials and products
cleaning operations
77
division of cleaning practices
1. deep cleaning 2. housekeeping cleaning 3. maintenance cleaning
78
design of the appropriate **clean attire** should not have the following
* fiber materials * pocket at upper part of the waist
79
# 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
true
80
# TRUE OR FALSE cleaning and sanitation alone **can assure** a hygienic standard in production
false | cannot assure; process and personal hygiene are also important
81
examples of sanitary facilities
* water supply * plumbing * toilet facilities * handwashing facilities * rubbish disposal * changing facility or locker

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