TOPIC 2 Standards and Quality Variation Flashcards

WEEK 2

1
Q

are defined as 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 standards

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2
Q

defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. ____ are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval

A

Specification

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3
Q

defined
as 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

Standards
(ASQ)

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4
Q

is a list of detailed
requirements (acceptance
criteria for the prescribed test
procedures) with which the
substance or pharmaceutical
product has to conform to
ensure suitable quality.

A

Specification

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5
Q

To avoid producing a defective
product, 1.__& 2. ___ are developed to
serve as basis for accepting or
rejecting a product.
Example of this is 3.___

A

Standards and Specifications

1-2. standards and
specifications
3. Drug Reference Standard
(RS)

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6
Q

is a standardized substance which is
used as a measurement base for similar
substances. Where the exact active
substances of a new drug are not known, a
reference standard provides a calibrated
level of biological effects against which new
preparations of the drug can be compared.

A

Drug Reference Standard
(RS)

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7
Q

This is concise and precise statement of the
ingredients that comprise the product, together with the
percentage and/or weight of each.

A

Formula

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8
Q

This should enumerate
the characteristics of all the materials that go into the
product and the permissible range of purity of each
ingredient. Standard compendia like the USP, NF, BP,
BPC, Merck Index, etc., provide this valuable
information.

A

Raw Material Specification

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9
Q

This is a
step by step method on how to go about a
job. It must spell out all information and
instructions that assure that variations in
production from day to day and week to
week will be held to within acceptable
established ranges.

A

Standard Operating Procedure.

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10
Q

This should
be set for everything that goes around the
product, i.e., bottles, cans, aluminum foil,
cellophane, jars, caps, cap liners, labels,
printed inserts, cartons, wrapping papers,
and shipping cases.

A

Packaging Material Standard

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11
Q

This
should cover all characteristics that affect
the proper performance, purity, safety and
stability of the product.

A

Finished Product Specification

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12
Q

These are indispensable
in assuring conformity to standards. Since
they play such a vital role, testing
procedures must be standardized so that
they yield results of comparable precision
and accuracy in the hands of different
operators and laboratories. The tests must
be validated to ensure precision and
accuracy on application.

A

Testing Methods

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13
Q

What are the Official References: (primary)

A

v United States Pharmacopoeia and National Formulary
v Japan Pharmacopeia
v British Pharmacopeia
v European Pharmacopeia
v International Pharmacopeia

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14
Q

is a legally
binding collection, prepared by a
national or regional authority of
standards and quality
specifications for medicines used
in that country or region

A

Pharmacopoeia

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15
Q

a is used to furnish quality
specifications for active pharmaceutical
ingredients (APIs), FPPs and general
requirements.

A

Pharmacopoeia

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16
Q

presents the basic assumptions,
definitions, and default conditions for the
interpretation and application of the USPNF

A

General Notices Section

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17
Q

Requirements stated apply to all
articles recognized in the USP and NF
and to all general chapters unless
specifically stated otherwise.

A

General Notices Section

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18
Q

General Chapters 1 to 999

Example is 1.__

A

Physical tests and determinations,
microbiological tests, Chemical tests and
assays, Biological tests and assays

  1. ENFORCEABLE
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19
Q

General Chapters 1000 to 1999

A

General Information (no
mandatory requirement)

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20
Q

General Chapter Above 2000

A

apply to articles classified as
Dietary ingredient or supplements

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21
Q

<1>

A

Injections

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22
Q

<2>

A

Oral Drug Products—Product Quality Tests

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23
Q

<231>

A

Heavy Metals

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24
Q

<621>

A

Chromatography

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25
Q

<671>

A

Containers

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26
Q

<761>

A

Nuclear Magnetic Resonance

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27
Q

<851>

A

Spectrophotometry

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28
Q

<781>

A

Optical Rotation

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29
Q

<1160>

A

Pharmaceutical Calculations in
Prescription Compounding

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30
Q

<1176>

A

Prescription Balances and Volumetric
Apparatus Used in Compounding:

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31
Q

<2232>

A

Elemental Contaminants in Dietary
Supplements

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32
Q

<2750>

A

Manufacturing Practices for Dietary
Supplements

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33
Q

is a combination of two official compendia:

A

The USP–NF

1-2. United States Pharmacopeia (USP) and the National
Formulary (NF).

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34
Q

Monographs for drug substances and preparations are
featured in the 1.__

A
  1. USP
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35
Q

Monographs for 1-2. __
appear in a separate section of the USP.

A
  1. dietary supplements and ingredients
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36
Q

Excipient monographs are found in the 1.___

A

NF.

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37
Q

Year of creation to signing of the first Philippine
Pharmacopeia in cooperation with the Japanese
Government through the initiatives of 2-3.___

A
  1. 1996
    2-3. Dr. Conrado S.
    Dayrit and Prof Akira Hamada.
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38
Q
  1. When was the creation of Pharmacopeia Organization
    for the preparation and publication of the Phil
    Pharmacopeia thru 2
  2. Declaring and adopting the Phil Pharmacopeia as the Official book of Standards
    nd Reference for Pharmaceutical Products and Crude plant drugs in the Philippines
A
  1. May 26, 1999
  2. Department Order no. 216-F
  3. Exec. Order 302 (2004)
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39
Q

approved Standard Setting Organization
or its foreign equivalent

A
  1. ANSI
    Standards Setting Organization (SSO)
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40
Q

a government sponsored organization
(where sponsorship is not based solely on financial
contributions by the government), a multimember consortia or industry recognized
organization Standards Setting Organization (SSO)

A

Standards Setting Organization (SSO)

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41
Q

(Guidelines: Norms and Standards for Pharmaceuticals)

A

WHO

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42
Q

Current Good Manufacturing Practice (CGMP) Regulations

A

FDA

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43
Q

Adoption and Implementation of the
Pharmaceutical Inspection and Scheme )PIC/S) Guides for the
Good manufacturing practice for medicinal products

A

AO 2012 – 0008

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44
Q

Guidelines for The Classification of
Deficiencies Observed During Inspection of Drug Manufacturers

A

Circular No.2019-003

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45
Q

is the
leading the international development, implementation and
maintenance of harmonized GMP standards and quality systems of
Inspectorates in the field of medicinal products

A

PIC/S - Pharmaceutical Inspection Cooperation Scheme Guides

◎ICH - International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use:

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46
Q

Establish a uniform set of standards for drug
registration

non-profit Association under Swiss law on
2.___

A
  1. International Council for Harmonisation of Technical
    Requirements for Pharmaceuticals for Human Use
  2. October 23, 2015
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47
Q

Brings the regulatory authorities and pharmaceutical
industry to discuss about scientific and technical aspects
about drug registration.

A

International Council for Harmonisation

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48
Q

Reduction of unnecessary animal testing without
compromising safety and effectiveness accomplished
through 1.__ that are implemented by the
regulatory authorities.

A

Technical Guidelines

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48
Q

Main goal of International Council for Harmonisation is to

A

achieve greater harmonization worldwide.

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48
Q

ICH - Purpose
Promotion of public health through international
harmonisation that contributes to: 1-4.

A
  • Prevention of unnecessary duplication of clinical trials and
    post market clinical evaluations
  • Development and manufacturing of new medicines
  • Registration and supervision of new medicines
  • Reduction of unnecessary animal testing without
    compromising safety and effectiveness accomplished
    through Technical Guidelines that are implemented by the
    regulatory authorities
49
Q

ICH – Founding members
1-5.

A
  1. Europe
  2. European Commission
  3. Japan
  4. Ministry of Health, Labor and Welfare (MHLW)
  5. or Pharmaceuticals and Medical Devices Agency (PMDA)
    US
50
Q

ICH – Standing Observers

A
  1. WHO
  2. International Federation of Pharmaceutical Manufacturers and
    Associations (IFPMA) Observers

Regulatory authorities

Regional Harmonisation Initiatives

international industry pharmaceutical organisations

international organisations regulated or affected by ICH Guidelines

51
Q

Clinical trials conducted in one ICH region can be used in
other ICH regions by setting the common standards on
science and ethics.

A

GCP (Good Clinical Practice)

52
Q

brings together all Quality, Safety and Efficacy
information in a common, harmonised format, accepted
by regulators in all ICH regions. It has revolutionised
regulatory review processes for regulators and industry.

A

CTD/eCTD (Common Technical Document)

53
Q

Highly specific, standardised medical terminology
developed by ICH to facilitate sharing of regulatory
information

A

MedDRA (Medical Dictionary for Regulatory Activities)

54
Q

It is used for registration, documentation and safety
monitoring of medical products both before and after
marketing authorisation

A

MedDRA (Medical Dictionary for Regulatory Activities)

55
Q

ICH Guidelines

A

› Quality – 14 Guidelines
› Safety - 23 Guidelines
› Efficacy – 21 Guidelines
› Multidisciplinary - 6 Guidelines

56
Q

14 Guidelines

A

Quality

57
Q

Safety - 23 Guidelines

A

Safety

58
Q

21 Guidelines

A

Efficacy

59
Q

6 Guidelines

A

Multidisciplinary

60
Q

stability studies,
defining relevant
thresholds for impurities
testing and a more
flexible approach to
pharmaceutical quality

A

Quality

61
Q

potential risks
like carcinogenicity,
genotoxicity and
reprotoxicity

A

Safety

62
Q

conduct,
safety and reporting
of clinical trials

A

Efficacy

63
Q

ICH medical
terminology (MedDRA), the Common
Technical Document (CTD) and the
development of Electronic Standards for
the Transfer of Regulatory Information
(ESTRI).

A

Multidisciplinary

64
Q

Q
S
E
M

A

QUALITY
SAFETY
EFFICACY
MULTIDISCIPLINARY

65
Q

Q4B-Annex 7

A

Dissolution Test General Chapter

66
Q

ICH QUALITY GUIDELINES

A
  1. Finished Product Control
    Compendial Requirements for Liquid and Solid Dosage Forms (ICH Q6)
  2. Statistical Quality Control (ICH Q9, Annex I.9- Supporting Statistical Tools)
  3. Stability Studies (ICH Q1)
  4. Validation (ICH Q2)
67
Q

(ICH Q6)

A

Finished Product Control
Compendial Requirements for Liquid and Solid Dosage Form

68
Q

(ICH Q9, Annex I.9- Supporting Statistical Tools)

A

Statistical Quality Control

69
Q

(ICH Q1)

A

Stability Studies

70
Q

is an undesirable characteristic of a
product.

A

defect

71
Q

(ICH Q2)

A

Validation

72
Q

It is defined as a failure to conform to
specifications.

A

defect

73
Q

A unit of a product which contains one or
more defects is called a ___.

A

defective

74
Q

Any unwanted event that represents a departure from
approved processes or procedures or instruction
or specification or established standard or from
what is required. Deviations can occur during
manufacturing, packing, sampling and testing of drug
products.

A

Deviation

75
Q

change in data, expected
outcomes, or slight
changes in production
quality

A

VARITION

76
Q

Examples of Defects: 1-13

A

› Mottling
› Chipping
› Lamination
› Telescoping
› Caking
› Coalescence
› Creaming
› Off-color
› Capping
- wrong volume
- missing label
- misplaced dropper
- sub potent

77
Q

– a defect which can be measured
directly by instruments.

Examples are: 1-8

A

Variable defect

Ex. length, weight, height, thickness, concentration,
volume, viscosity, pH or size particles.

78
Q

– a defect which cannot be measured
directly by instruments. It shows mainly the conformance
or nonconformance.

Examples are: 1-6

A

Attribute defect

Ex. Functional, Texture, presence of dents, cracks,
missing buttons, cracks

79
Q

Attribute defect can be ___

A

Counted

80
Q

a defect which may endanger life or
property and may render the product non – functional.

Examples are: 1.

A

Critical defect

Ex: Absence of a warning in a label for a potent drug
or disintegration time of one hour for an analgesic.

80
Q

a defect which may affect the function
of the object and therefore, may render the product
useless or aesthetically objectionable

A

Major defect

Ex: Presence of a crack in a bottle.

81
Q

Stains that may appear

A

Major defect

82
Q

a defect which does not
endanger life or property nor will it affect
the function but nevertheless remains a
defect since it is outside the prescribed
limits.

Examples are: 1

A

Minor defect

Ex: slight deviation of the color of the label from the color standards.

83
Q

Scratches or dents

A

Minor defect

83
Q

What are defect According to measurability: 1-2

A

Variable defect
Attribute defect

84
Q

According to seriousness or gravity:

A

Critical defect
Major defect
Minor defect

85
Q

According to nature:

A

Ocular defect
Internal defect
Performance defect

85
Q

a defect that is visible.

A

Ocular defect

e.g., foreign particulate contamination.

86
Q

a defect which is not seen although
present.

A

Internal defect

e.g., a sub – potent drug product.

87
Q

a defect in function.

A

Performance defect

e.g., suppository that does not melt at body
temperature.

88
Q

is the method of withdrawing or correcting
unsafe or hazardous health products from the
distribution chain that may present a health hazard
to the consumer or user.

A

Recall

89
Q

a situation in which there is a reasonable
probability that the use of or exposure to a violative product will
cause serious adverse health consequences or death.

A

Class I recall

90
Q

a situation in which use of or exposure to a
violative product may cause temporary or medically reversible
adverse health consequences or where the probability of
serious adverse health consequences is remote.

A

Class II recall

91
Q

a situation in which use of or exposure to a
violative
product is not likely to cause adverse health consequences

A

Class III recall

92
Q

Class I Pathogens:

A

I- Salmonella, Listeria monocytegenes, E.
coli, Clostridium

93
Q

Class II Pathogens:

A

II – Shigella, Cyclospora, Cryptosporidium,
hepatitis A

94
Q

Class III Pathogens:

A

III – Low levels of pesticide residue

95
Q

Type of Defects
Adverse reactions related to a product
defect.

A

}Packaging, bottling/filling and labelling.
}Deviations from specifications
}Contamination
}Packaging defects

96
Q

Other deviations: Other deviations typically
concern reports of non-compliance with GMP,
counterfeit medicines, authorized variation
applications and the suspension of marketing
authorizations leading to withdrawals, as well as
defects related to the product itself, e.g. precipitation,

A
97
Q

Product Recall
Examples:

A

› wrong (potent) product (label and contents are different products) with serious medical
consequences
› chemical or microbial contamination with serious
medical consequences or in sterile preparations
› wrong active ingredient in a multi-component
product with serious medical consequences.
› Defective pacemaker, defibrillator
› Hot/cold packs containing toxic substances
› Software and hardwares (used for critical conditions) defects

98
Q

Product Recall
Examples:

A

› mislabeling (for example, incorrect or missing text
or figures)
› non-compliance with specification, such as in an
assay, stability, fill or weight resulting in medical
consequences
› insecure or incorrect closures for medicines such
as cytotoxics, potent products and medicines
requiring child-resistant packaging resulting in medical consequences.
› faulty packaging, such as wrong or missing batch
number or expiry date
› faulty closure not resulting in any medical
consequences
› contamination with no medical consequences

99
Q

Sources and Control of
Quality Variation

manufacturing processes become more
complex –>

A

The risk of errors increases

100
Q

material control, GMP, packaging control,
automation and statistical sampling plans
are employed –>

A

To minimize and
eliminate the sources of errors which can
cause product quality variation

101
Q

Sources of Variation:

A

materials
machines
methods
men

102
Q

Variation between suppliers of same
substance.

A

materials

103
Q

Variation of equipment for the same
process.

A

machines

104
Q

Inexact procedures.

A

methods

105
Q

Variation between batches from same
supplier.

A

materials

106
Q

Aging and improper care.

A

machines

106
Q

Negligence by chance.

A

methods

107
Q

Inadequate procedures.

A

methods

107
Q

Difference in adjustment of equipment.

A

machines

108
Q

Variation within a batch.

A

materials

109
Q

Improper working conditions.

A

men

110
Q

Inadequate training, and understanding.

A

men

111
Q

Dishonesty, fatigue and carelessness.

A

men

112
Q

a visualization tool for categorizing the
potential causes of a problem in order to
identify its root causes.

A
113
Q

A fishbone diagram,____
diagram or Ishikawa diagram

A

“cause and effect”

114
Q

› Dr. Kaoru Ishikawa, a Japanese quality
control expert: 1-2

A

Quality improvement is a continuous process

Customer continued service

115
Q

4P’s

A

(Policies, Procedures, People and
Plant

116
Q
A