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PRELIMS > PMQA - PRELIMS > Flashcards

PMQA - PRELIMS Flashcards

1
Q

_____ is presently considered as an advance
course, it deals with the “technology
various official and non-official products
manufactured in a semi-commercial and commercial scale.”

A

MANUFACTURING PHARMACY

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2
Q

refers to pharmaceutical research and
manufacturing companies providing
pharmacists with medicines in prefabricated or ready-to-take forms.

A

INDUSTRIAL PHARMACY

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3
Q

INDUSTRIAL PHARMACY relates to the following (2):

A
  1. Practice of pharmacy in some
    hospitals
  2. Large scale production carried
    out in modern pharmaceutical plants
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4
Q

NABP

A

National Association of Boards of Pharmacy

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5
Q

is the preparation, mixing, assembling,
packaging, or labeling of drug or device
as the result of a
prescription drug order or initiative based
on the pharmacist or patient or prescriber
relationship in the course of professional
practice

A

Compounding

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6
Q

also includes the preparation of drugs and
devices in anticipation of prescription
drug orders based on routine, regularly
observed patterns

A

Compounding

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7
Q

for the purpose of, as an incident to
research, teaching, or chemical analysis
and not for sale or dispensing

A

Compounding

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8
Q

for the purpose of, as an incident to
research, teaching, or chemical analysis
and not for sale or dispensing

A

Compounding

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9
Q

has been defined as the production,
preparation, propagation, conversion or
processing of a drug or device, either by
directly or indirectly, by extraction from
substances of natural origin or
independently by means of chemical or
biological synthesis.

A

Manufacturing

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10
Q

and includes any packaging or
repackaging of the substances or labeling
or relabeling of its container, and the
promotion and marketing of such drugs
or devices

A

Manufacturing

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11
Q

and includes any packaging or
repackaging of the substances or labeling
or relabeling of its container, and the
promotion and marketing of such drugs
or devices

A

Manufacturing

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12
Q

also includes the preparation and
promotion of commercially available
products from bulk compounds for resale
by pharmacies, practitioners, or other
persons.

A

Manufacturing

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13
Q

USP

A

United States Pharmacopeia

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14
Q

is used to refer to
compounded
prescriptions

A

preparation

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15
Q

is used to refer to
manufactured
pharmaceuticals

A

products

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16
Q

compounded
preparations are
assigned a _____ date

A

beyond-use

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17
Q

while manufactured
products are
assigned an _____ date

A

expiration

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18
Q

a mechanism for determining and
assigning duties to people, in order to
work effectively

A

Organization

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19
Q

combination of manpower, money,
machines and methods

A

Business Organization

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20
Q

Elements of Business Organization

A

Manpower, Money, Machine, Methods

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21
Q

Basic Elements of an Organization

A
  1. Division of Responsibility (Obligation or
    Duty)
  2. Delegation of Authority
  3. Determination of the Interrelationship
    among the functions of each of the
    component of the organizational plan
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22
Q

 Responsibility must be delegated.
 The company objectives must be determined and the organizational plan must be consulted with the aim of achieving them.

A

Division of Responsibility
(Obligation or Duty)

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23
Q

Authority must be defined and delegated
to avoid negligence of duty

A

Delegation of Authority

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24
Q

To promote harmonious teamwork.

A

Determination of the Interrelationship
among the functions of each of the component of the organizational plan

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25
Q

Basic Tools in an Organization

A

I. Organizational Planning
II. Position Description
III. Organizational Manual

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26
Q
  1. It lists all important positions and functions
    of each divisions or department
  2. It is a means of quickly showing the shape
    or structure of the company to employees
    and other interested parties outside the
    company
A

Characteristics of an Organizational Chart

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27
Q
  1. Can analyze organizational problems like
    overlapping of functions
  2. Can assess the strengths and weaknesses in the
    functions and personnel
  3. Can plan changes in the structure, if not
    applicable
A

Importance of a Chart

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28
Q
  1. Cannot reveal company objectives and policies
  2. Cannot indicate a delegated authority
  3. Reveals little about working relationships
A

Some Drawbacks in the Chart

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29
Q

It combines the chart and position
descriptions, with description materials
about the organization

A

Management Guide

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30
Q

Functions:
1. To protect and make the most effective
use of the assets of the company
2. Establishes objective and determines
the basic policies and general course of the
business
3. Represents and safeguards the interests
of the stockholders.

A

Level I- Board of Trustees or Board of
Directors

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31
Q

Function:
Active planning, direction, coordination
and control of the business within the scope
of policies established and authorized by
Level I management.

A

Level II- President

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32
Q

Functions:
1. Manages the major departments of the
company
2. They are fully responsible and accountable to
the Level II management for the success of their
respective operations.
3. They embraces the topmost level of
executives concerned with a particular division of
the company rather than the enterprise, as a whole.

A

Level III- Vice President, General
Managers and Department Managers

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33
Q
  • it groups all activities on the basis of the
    functions alone. This is more appropriate for a small company or one with closely related products.
A

Functional Structure

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34
Q
  • All production, sales, and financial activities are under one head. It is flexible, facilities and coordination, and encourages specialization in the field.
A

. Functional Structure

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35
Q
  • it combines into one unit, all different kinds of work necessary to accomplish a specific
    result. The kinds of work necessary may be
    grouped on a geographical basis or more
    commonly on a product basis.
A

Divisionalized Structure

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36
Q
  • it is identified as the chain of command from top to
    the bottom of the organization.
  • constitutes the framework of the organizational
    structure
  • have direct responsibility to accomplish the
    objectives of the enterprise
  • have the power or authority to initiate and carry
    through other primary activities necessary to reach the
    stated goal of the company
A

LINE

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37
Q

constitutes the work functions or the
organization component that are required
to supply information and services to the “line” components

A

STAFF

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38
Q

FIVE (5) MAJOR DEPARTMENTS

A

I. Personnel
II. Finance
III. Marketing
IV. Technical Director
1. Research & Product Development and QC
V. Plant

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39
Q

-coordinates labor and management
relationship

A

Personnel department

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40
Q

consist of cost accounting, forecast and
budget and general accounting

A

Finance department

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41
Q

consist of market research, sales and
detailing and advertising

A

Marketing department

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42
Q

research and product development,
quality control of drugs and
cosmetics

A

Technical director

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43
Q

production control, warehouse,
manufacture of pharmaceuticals,
manufacture of cosmetics and
maintenance

A

Plant department

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44
Q

Research & Product Development Types (3)

A

1) Chemical research
2) Biological research
3) Pharmaceutical research

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45
Q

Biological Research (3)

A

1) Pharmacology
2) Animal Research
3) Microbiology

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46
Q

3 STAGES OF RESEARCH

A

Preliminary Stage
Applied Research Stage
Clinical Research Stage

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47
Q

consist of market research, literature
review, patent search and raw
materials.

A

Preliminary stage

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48
Q
  • consist of chemical studies,
    development of chemical process and
    cost research.
A

Applied research stage

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49
Q

consist of manufacturing requirements,
research on label, review of basic
information, product control, contract
with therapeutic trial committee, patent
application, and cost of clinical trial.

A

Clinical research stage

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50
Q

PURPOSE:
1) Conform to appropriate standards of
identity, purity, potency, quality,
physiological availability and therapeutic
activity
2) meet government rules and regulations
3) prevent potential hazard to public health

A

I. Specification & Assay Development Section

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51
Q

A. Raw materials & containers
specifications
B. Finished product specifications

A

I. Specification & Assay Development Section

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52
Q

Usual criteria: description, solubility, ID,
melting point, loss on ignition, residue on
ignition, specific rotation, refractive index,
specific gravity, assay.

*Additional: particle size, crystal shape,
surface tension, viscosity, irritation, foreign
substance, allergenic substance, toxicity

A

Raw Materials

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53
Q

1) Physical changes of containers upon
prolonged contact with product
2) Moisture & gaseous permeability
3) Compatibility between container &
product
4) Toxicity and safety considerations

A

Containers

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54
Q

FINISHED PROUCT SPECIFICATION
* Developed jointly by

A
  • QC
    – Research and Product Development
    – Sales or Marketing Production
    – Management Individuals
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55
Q

2 Kinds of Impurities

A

1) Product specific impurities
2) Product unspecific impurities

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56
Q

Ex. degradation

A

Product specific impurities

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57
Q

External

A

Product unspecific impurities

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58
Q

-is a staff function as a service department
supporting but not subordinate to
production supervision

–Responsibility for quality is shared by all,
but QC has ultimate jurisdiction over the
release of every product manufactured
and/or filled and packaged

A

QUALITY CONTROL

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59
Q

requisitioned items for the company,
both from local and imported sources

A

Purchasing

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60
Q

watches closely and records all
materials used in production; controls the stock of both
raw materials and finished products; in charge of
checking stocks regularly

A

Inventory control

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61
Q

coordinates with marketing
on what products are required for supply and then plans
and schedules the manufacturing order (MO);
manufacturing at the time limit allowed.

A

Planning & Scheduling -

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62
Q

Raw material consists of 3 subdivisions

A

– Quarantined area
– Approved for use area
– Rejected area

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63
Q

consists of products which have been
bottled or stripped, packed but not
yet labeled, or packed into boxes or
cartons because they are awaiting QC
tests and assays for final disposition

A

In-process

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64
Q

this area contains the products
packaged and finished and are ready
for distribution and sale

A

Finished Product:

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65
Q

In as much as returns cannot be
avoided, goods returned are stored in
a section of the warehouse pending
disposition by QC control

A

Returned goods

66
Q

area where raw materials for use in production
are weighed and/or measured.

A

Dispensing

67
Q

should be pharmacist, checker is
required to avoid errors

A

Supervisor

68
Q

do routine checks on all areas of
warehouse

A

QC inspectors

69
Q

care and maintenance of all machines
used in the plant department
including electric lines, water lines,
repair of defective equipment.

A

Engineering & Maintenance section

70
Q

Prepares master formula

A

Manufacturing of Pharmaceuticals

71
Q

______ are regulations developed by the FDA.
_______are minimum requirement that the industry
must meet when manufacturing, processing, packing,
or holdGOOD MANUFACTURING
PRACTICES (GMPs)ing human and veterinary drugs

A

GOOD MANUFACTURING
PRACTICES (GMPs)

72
Q

These regulations. Also known as _______
establish criteria for personnel, facilities, and
manufacturing processes to ensure that the
finished drug product has the correct identity,
strength, quality, and purity characteristics

A

cGMPs,

73
Q

Group within the manufacturer that is responsible for establishing process and product specifications

A

QUALITY CONTROL

74
Q

criteria to which a drug product should
conform to be considered acceptable quality for its
intended use

A

Specifications

75
Q

tests the product and verifies that the
specifications are met .

A

QC unit

76
Q

includes the acceptance and rejection of
the incoming raw materials, packaging components,
drug products, water system, and environmental
conditions that exist during the manufacturing
process.

A

QC Testing

77
Q

is the group within the manufacturer that determines
that the systems and facilities are adequate, and that
the written procedures are followed to ensure that the
finished drug product meets the applicable
specifications for quality

A

QUALITY ASSURANCE

78
Q

Ensures that products are
consistently produced. The standard
of quality must be suitable for use.

A

Good Manufacturing Practice

79
Q

This administrative order was patterned after
the guidelines developed in 1963 by the USFDA with the participation of drug
companies

A

USFDA, Administrative Order no. 220 s. 1974

80
Q

Good Manufacturing Practices (GMP) is a
responsibility of:

A

1) Quality control
2) Production control

81
Q

Functions of the QUALITY CONTROL in
the GMP:

A
82
Q

Functions of the QUALITY CONTROL in
the GMP:

A

To audit or to inspect periodically

To detect non-compliance

83
Q

Objective of cGMP

A

To produce a product that is safe,
pure and effective.

84
Q

for drug firms manufacturing both ________
products, use of
the same area/premises, same equipment
and personnel is conductive to cross-contamination!

A

penicillin and non-penicillin

85
Q

means any ingredient intended for use in the
manufacturing of drugs, including those that may
not appear in the finished product.

A

Component (raw material)

86
Q

means a specific homogenous quantity of a
drug or in case of drug produced according to
single manufacturing order during the same
cycle of manufacture.

A

Batch

87
Q

means a batch or any portion of
a batch of a drug, produced by a
continuous process

A

Lot

88
Q

means any distinctive combination of
letters and/or numbers, or both, by
which the complete history of the
manufacture, control, packaging and
distribution of a batch or lot of a drug is
determined.

A

Lot number or control number

89
Q

means any substance of a drug, which is
intended to furnish
pharmacological activity

A

Active Ingredient

90
Q

means any
substance other than “Active
Ingredient” present in the drug
formulation.

A

Inactive Ingredient

91
Q

means any
organizational element having the
authority and responsibility to approve
or reject raw materials, in-process
materials, packaging components and
final products.

A

Materials Approval Unit

92
Q

means (a) the concentration
of a known active drug substance in the
formulation (b) potency, that is, the
specific ability or capacity of the product
as indicated by appropriate lab.

A

Strength

93
Q

At least _____ the quantity necessary for
all the required tests of identity, purity and
strength

A

twice

94
Q

For Components:
– At least ___ years after the distribution of
the last lot of the product incorporating
the components has been completed
or;

A

Two

95
Q

For Components:

____ year after the expiration date of
this last lot incorporating the
components.

A

One

96
Q

For Records
Cosmetics: at least____ years after the
manufacture is completed.

A

Three

97
Q

A Master formula records shall be
retained for a period of at least ___
years after the distribution of the
last drug batch produced using the
master-formula records;

A

Two

98
Q

Master Formula must be retained at least ___ year
after the expiration date of the
drug’s last batch, or whichever is
the shortest.

A

One

99
Q

For equipment and lines, the placement of
identification shall include;

A
  • input lines
  • output lines
  • operator controls
100
Q

Defined as the capability of
a particular formulation, in a
specific container/closure
system, to remain within its
physical, chemical,
microbiological, therapeutic, and
toxicological specifications.

A

Stability

101
Q

agreement among
repeated means

A

Precision

102
Q

closeness of
means to the true value

A

Accuracy

103
Q

ability to
distinguish intact drug from the
composition product

A

Specificity

104
Q

multiples of a
concentration will elicit a
corresponding response

A

Linearity

105
Q

Each active ingredient retains its
chemical integrity and labeled potency,
within the specified limits.

A

Chemical Stability

106
Q

The original physical properties,
including appearance, palatability,
uniformity, dissolution, and
suspendability

A

Physical Stability

107
Q

are found in specific
areas in the label and carton for
identification purposes

A

Bar marks

108
Q

It should be kept in mind that
____ is an aid and not a
substitute for a good total quality
assurance program.

A

GMP

109
Q
  • Acid-Base reaction
  • Precipitation reaction
  • Redox reaction
  • Complexation reaction
  • Anion-Cation reaction
A

Titrimetric Method

110
Q

A. Weighing Drug after
Separation
B. Weighing a Derivative after
Separation
C. Weighing a Residue after
Ignition

A

Gravimetric Method

111
Q

the measurement
of the amount of light absorbed by a
solution

A

Spectrophotometry

112
Q

the measurement of the
amount of light absorbed by a suspension

A

Turbidimetry

113
Q

the amount of light
scattered by a suspension

A

Nephelometry

114
Q
  • the intensity of the
    light emitted by an element when
    subjected to high temperatures
A

Flame Photometry

115
Q

the measurement of light in
the visible region

A

Colorimetry

116
Q

chroma

A

color

117
Q

graphein

A

to write

118
Q

is a procedure by
which solutes are separated by a differential
migration process in a system consisting of two or
more phases, one of which moves continuously in
a given direction and in which the individual
substances exhibit different mobilities by reason of
differences in adsorption, partition,
solubility, vapor pressure, molecular
size, or ionic charge density

A

Chromatography (USP)

119
Q

depend
on the measurement of the volume of a
gas liberated under the conditions that are
described in the assay

A

Gasometric Methods of analysis

120
Q

is meant the
determination of the amount of any
organic constituent that may be present in
any vegetable drug or plant to which its
value or therapeutic activity is attributed

A

Proximate Assay

121
Q

Refers to the duration of time
during which a drug preparation will
remain physically, chemically,
therapeutically, toxicology and
microbiology stable (possessing NLT
90% of the labeled potency)

A

Shelf Life

122
Q

Time interval required for the
active ingredient to be reduced to ½
of its initial value.

A

Half Life

123
Q

The time in which a drug
product in a specific packaging
configuration will remain stable
when stored under recommended
conditions

A

Expiration Date

124
Q

It is the sum of shelf life and the
date of manufacture.

A

Expiration Date

125
Q

It is expressed traditionally in terms
of month and year, denotes the last day
of the month. The expiration date should
appear on the immediate container and
the outer retail package

A

Expiration Date

126
Q

– a device that holds a drug and is,
or may be, in direct contact with the
drug.

A

Container

127
Q

it protects the
contents from
extraneous solids and
from loss of the drug
under ordinary
conditions of handling,
shipment, storage and
distribution

A

Well-closed

128
Q

protects the contents
from contamination by
extraneous liquids,
solids or vapors from
loss of the drug and
from efflorescence,
deliquescence or
shipment, storage and
distribution

A

Tight container

129
Q

– containers that
prevent photochemical
decomposition of
substances that are
photosensitive

A

Light-resistant
containers

130
Q

container that is
impervious to air or any
other gas under the
ordinary or customary
conditions of handling,
shipment, storage and
distribution

A

Hermetic container

131
Q

25°C and -10°C
(-13 and -14o

A

Freezer

132
Q

Not exceeding 8°C
(46oF)

A

Cold

133
Q

Controlled 2-8°C
(36 & 46oF)

A

Refrigerator

134
Q

8-15°C
(46 and 59oF)

A

Cool

135
Q

30C-40C

A

Warm

136
Q

Above 40C

A

Excessive heat

137
Q

Protect below 0C

A

Protection from
freezing:

138
Q

Food, Drug and Cosmetic Act

A

R.A. 3720 (1963)

139
Q

Revenue Regulation 16-67

A

Narcotic Drug Regulation

140
Q

General regulations for the Enforcement of
the Food, Drug, Cosmetic Act (A-7
Operation for drug establishment, A-8
Requirements for cosmetic laboratory

A

A.O. 60 s. 1968

141
Q

General regulations for the Enforcement
of the Food, Drug, and Cosmetic Act
(C-3 Misbranding: Drug and Devices)

A

A.O. 61 s. 1968

142
Q

Regulation Part C-9:
Drugs: Registration of drugs and
pharmaceutical Specialties

A

A.O. 101 s. 1969

143
Q

Regulation Part C-1
Drug labeling:
Prescription drug
Label symbol

A

A.O. 109 s. 1969

144
Q

Regulation Part C-10
* Statement of Lot number
* Expiration date
* Registration number
* Storage conditions of pharmaceutical
Specialties

A

A.O. 126 s. 1970

145
Q

Regulation Part D-4:
Cosmetic: Registration of Cosmetic
Specialties

A

A.O. 150 s. 1971

146
Q

Regulation Part C-3.2:
Drug: Prohibition of the use of more than
one name for a given formulation

A

A.O. 132 s. 1970

147
Q

Regulation Part C-7
Drug and Devices:
Certification of Antibiotics

A

A.O. 151 s. 1971

148
Q

Restricted Use of Boric acid and Sodium
Borate (Borax)

A

A.O. 195 s. 1973

149
Q

CGMP in Manufacture, Processing, Packing and
Holding

A

A.O. 220 s. 1974

150
Q

Ban on the Use of Chloroform
(Trichloromethane)

A

A.O. 341 s. 1978

151
Q

Banning Tetracycline for Children under 8 yrs.
Old

A

A.O. 342 s. 1978

152
Q

The need and role for a MEDICAL
DIRECTOR in the Pharmaceutical
Industries

A

A.O. 34 s. 1979

153
Q

Restriction on the use of several BRAND
NAMES for formulation of a drug or
pharmaceutical specialty

A

A.O. 38 s. 1979

154
Q

also known as ICH Q10 model
◦ describes one comprehensive model for an effective
pharmaceutical quality system that is based on International
Organization for Standardization (ISO) quality concepts
◦ a model for a pharmaceutical quality system that can be
implemented throughout the different stages of a product
lifecycle

A

PHARMACEUTICAL QUALITY SYSTEM

155
Q

CAPA

A

Corrective Action and Preventive
Action

156
Q

damage to health, including the damage that can occur from loss of
product quality or availability.

A

Harm

157
Q

the potential source of harm (ISO/IEC Guide 51)

A

Hazard

158
Q

all phases in the life of the product from the initial
development through marketing until the product’s discontinuation.

A

Product lifecycle

159
Q

the degree to which a set of inherent properties of a product, system or
process fulfills requirements (see ICH Q6A definition specifically for “quality” of
drug substance and drug (medicinal) products.)

A

Quality

160
Q

a systematic process for the assessment, control,
communication and review of risks to the quality of the drug (medicinal) product
across the product lifecycle

A

Quality Risk Management

161
Q

the combination of the probability of occurrence of harm and the severity
of that harm

A

Risk

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