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
2
Q
refers to pharmaceutical research and
manufacturing companies providing
pharmacists with medicines in prefabricated or ready-to-take forms.
A
INDUSTRIAL PHARMACY
3
Q
INDUSTRIAL PHARMACY relates to the following (2):
A
- Practice of pharmacy in some
hospitals - Large scale production carried
out in modern pharmaceutical plants
4
Q
NABP
A
National Association of Boards of Pharmacy
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
6
Q
also includes the preparation of drugs and
devices in anticipation of prescription
drug orders based on routine, regularly
observed patterns
A
Compounding
7
Q
for the purpose of, as an incident to
research, teaching, or chemical analysis
and not for sale or dispensing
A
Compounding
8
Q
for the purpose of, as an incident to
research, teaching, or chemical analysis
and not for sale or dispensing
A
Compounding
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
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
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
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
13
Q
USP
A
United States Pharmacopeia
14
Q
is used to refer to
compounded
prescriptions
A
preparation
15
Q
is used to refer to
manufactured
pharmaceuticals
A
products
16
Q
compounded
preparations are
assigned a _____ date
A
beyond-use
17
Q
while manufactured
products are
assigned an _____ date
A
expiration
18
Q
a mechanism for determining and
assigning duties to people, in order to
work effectively
A
Organization
19
Q
combination of manpower, money,
machines and methods
A
Business Organization
20
Q
Elements of Business Organization
A
Manpower, Money, Machine, Methods
21
Q
Basic Elements of an Organization
A
- Division of Responsibility (Obligation or
Duty) - Delegation of Authority
- Determination of the Interrelationship
among the functions of each of the
component of the organizational plan
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)
23
Q
Authority must be defined and delegated
to avoid negligence of duty
A
Delegation of Authority
24
Q
To promote harmonious teamwork.
A
Determination of the Interrelationship
among the functions of each of the component of the organizational plan
25
Basic Tools in an Organization
I. Organizational Planning
II. Position Description
III. Organizational Manual
26
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
Characteristics of an Organizational Chart
27
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
Importance of a Chart
28
1. Cannot reveal company objectives and policies
2. Cannot indicate a delegated authority
3. Reveals little about working relationships
Some Drawbacks in the Chart
29
It combines the chart and position
descriptions, with description materials
about the organization
Management Guide
30
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.
Level I- Board of Trustees or Board of
Directors
31
Function:
Active planning, direction, coordination
and control of the business within the scope
of policies established and authorized by
Level I management.
Level II- President
32
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.
Level III- Vice President, General
Managers and Department Managers
33
- 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.
Functional Structure
34
- All production, sales, and financial activities are under one head. It is flexible, facilities and coordination, and encourages specialization in the field.
. Functional Structure
35
- 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.
Divisionalized Structure
36
- 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
LINE
37
constitutes the work functions or the
organization component that are required
to supply information and services to the "line" components
STAFF
38
FIVE (5) MAJOR DEPARTMENTS
I. Personnel
II. Finance
III. Marketing
IV. Technical Director
1. Research & Product Development and QC
V. Plant
39
-coordinates labor and management
relationship
Personnel department
40
consist of cost accounting, forecast and
budget and general accounting
Finance department
41
consist of market research, sales and
detailing and advertising
Marketing department
42
research and product development,
quality control of drugs and
cosmetics
Technical director
43
production control, warehouse,
manufacture of pharmaceuticals,
manufacture of cosmetics and
maintenance
Plant department
44
Research & Product Development Types (3)
1) Chemical research
2) Biological research
3) Pharmaceutical research
45
Biological Research (3)
1) Pharmacology
2) Animal Research
3) Microbiology
46
3 STAGES OF RESEARCH
Preliminary Stage
Applied Research Stage
Clinical Research Stage
47
consist of market research, literature
review, patent search and raw
materials.
Preliminary stage
48
- consist of chemical studies,
development of chemical process and
cost research.
Applied research stage
49
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.
Clinical research stage
50
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
I. Specification & Assay Development Section
51
A. Raw materials & containers
specifications
B. Finished product specifications
I. Specification & Assay Development Section
52
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
Raw Materials
53
1) Physical changes of containers upon
prolonged contact with product
2) Moisture & gaseous permeability
3) Compatibility between container &
product
4) Toxicity and safety considerations
Containers
54
FINISHED PROUCT SPECIFICATION
* Developed jointly by
- QC
– Research and Product Development
– Sales or Marketing Production
– Management Individuals
55
2 Kinds of Impurities
1) Product specific impurities
2) Product unspecific impurities
56
Ex. degradation
Product specific impurities
57
External
Product unspecific impurities
58
-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
QUALITY CONTROL
59
requisitioned items for the company,
both from local and imported sources
Purchasing
60
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
Inventory control
61
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.
Planning & Scheduling -
62
Raw material consists of 3 subdivisions
– Quarantined area
– Approved for use area
– Rejected area
63
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
In-process
64
this area contains the products
packaged and finished and are ready
for distribution and sale
Finished Product:
65
In as much as returns cannot be
avoided, goods returned are stored in
a section of the warehouse pending
disposition by QC control
Returned goods
66
area where raw materials for use in production
are weighed and/or measured.
Dispensing
67
should be pharmacist, checker is
required to avoid errors
Supervisor
68
do routine checks on all areas of
warehouse
QC inspectors
69
care and maintenance of all machines
used in the plant department
including electric lines, water lines,
repair of defective equipment.
Engineering & Maintenance section
70
Prepares master formula
Manufacturing of Pharmaceuticals
71
______ 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
GOOD MANUFACTURING
PRACTICES (GMPs)
72
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
cGMPs,
73
Group within the manufacturer that is responsible for establishing process and product specifications
QUALITY CONTROL
74
criteria to which a drug product should
conform to be considered acceptable quality for its
intended use
Specifications
75
tests the product and verifies that the
specifications are met .
QC unit
76
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.
QC Testing
77
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
QUALITY ASSURANCE
78
Ensures that products are
consistently produced. The standard
of quality must be suitable for use.
Good Manufacturing Practice
79
This administrative order was patterned after
the guidelines developed in 1963 by the USFDA with the participation of drug
companies
USFDA, Administrative Order no. 220 s. 1974
80
Good Manufacturing Practices (GMP) is a
responsibility of:
1) Quality control
2) Production control
81
Functions of the QUALITY CONTROL in
the GMP:
82
Functions of the QUALITY CONTROL in
the GMP:
To audit or to inspect periodically
To detect non-compliance
83
Objective of cGMP
To produce a product that is safe,
pure and effective.
84
for drug firms manufacturing both ________
products, use of
the same area/premises, same equipment
and personnel is conductive to cross-contamination!
penicillin and non-penicillin
85
means any ingredient intended for use in the
manufacturing of drugs, including those that may
not appear in the finished product.
Component (raw material)
86
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.
Batch
87
means a batch or any portion of
a batch of a drug, produced by a
continuous process
Lot
88
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.
Lot number or control number
89
means any substance of a drug, which is
intended to furnish
pharmacological activity
Active Ingredient
90
means any
substance other than “Active
Ingredient” present in the drug
formulation.
Inactive Ingredient
91
means any
organizational element having the
authority and responsibility to approve
or reject raw materials, in-process
materials, packaging components and
final products.
Materials Approval Unit
92
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.
Strength
93
At least _____ the quantity necessary for
all the required tests of identity, purity and
strength
twice
94
For Components:
– At least ___ years after the distribution of
the last lot of the product incorporating
the components has been completed
or;
Two
95
For Components:
____ year after the expiration date of
this last lot incorporating the
components.
One
96
For Records
Cosmetics: at least____ years after the
manufacture is completed.
Three
97
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;
Two
98
Master Formula must be retained at least ___ year
after the expiration date of the
drug’s last batch, or whichever is
the shortest.
One
99
For equipment and lines, the placement of
identification shall include;
* input lines
* output lines
* operator controls
100
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.
Stability
101
agreement among
repeated means
Precision
102
closeness of
means to the true value
Accuracy
103
ability to
distinguish intact drug from the
composition product
Specificity
104
multiples of a
concentration will elicit a
corresponding response
Linearity
105
Each active ingredient retains its
chemical integrity and labeled potency,
within the specified limits.
Chemical Stability
106
The original physical properties,
including appearance, palatability,
uniformity, dissolution, and
suspendability
Physical Stability
107
are found in specific
areas in the label and carton for
identification purposes
Bar marks
108
It should be kept in mind that
____ is an aid and not a
substitute for a good total quality
assurance program.
GMP
109
* Acid-Base reaction
* Precipitation reaction
* Redox reaction
* Complexation reaction
* Anion-Cation reaction
Titrimetric Method
110
A. Weighing Drug after
Separation
B. Weighing a Derivative after
Separation
C. Weighing a Residue after
Ignition
Gravimetric Method
111
the measurement
of the amount of light absorbed by a
solution
Spectrophotometry
112
the measurement of the
amount of light absorbed by a suspension
Turbidimetry
113
the amount of light
scattered by a suspension
Nephelometry
114
- the intensity of the
light emitted by an element when
subjected to high temperatures
Flame Photometry
115
the measurement of light in
the visible region
Colorimetry
116
chroma
color
117
graphein
to write
118
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
Chromatography (USP)
119
depend
on the measurement of the volume of a
gas liberated under the conditions that are
described in the assay
Gasometric Methods of analysis
120
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
Proximate Assay
121
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)
Shelf Life
122
Time interval required for the
active ingredient to be reduced to ½
of its initial value.
Half Life
123
The time in which a drug
product in a specific packaging
configuration will remain stable
when stored under recommended
conditions
Expiration Date
124
It is the sum of shelf life and the
date of manufacture.
Expiration Date
125
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
Expiration Date
126
– a device that holds a drug and is,
or may be, in direct contact with the
drug.
Container
127
it protects the
contents from
extraneous solids and
from loss of the drug
under ordinary
conditions of handling,
shipment, storage and
distribution
Well-closed
128
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
Tight container
129
– containers that
prevent photochemical
decomposition of
substances that are
photosensitive
Light-resistant
containers
130
container that is
impervious to air or any
other gas under the
ordinary or customary
conditions of handling,
shipment, storage and
distribution
Hermetic container
131
25°C and -10°C
(-13 and -14o
Freezer
132
Not exceeding 8°C
(46oF)
Cold
133
Controlled 2-8°C
(36 & 46oF)
Refrigerator
134
8-15°C
(46 and 59oF)
Cool
135
30C-40C
Warm
136
Above 40C
Excessive heat
137
Protect below 0C
Protection from
freezing:
138
Food, Drug and Cosmetic Act
R.A. 3720 (1963)
139
Revenue Regulation 16-67
Narcotic Drug Regulation
140
General regulations for the Enforcement of
the Food, Drug, Cosmetic Act (A-7
Operation for drug establishment, A-8
Requirements for cosmetic laboratory
A.O. 60 s. 1968
141
General regulations for the Enforcement
of the Food, Drug, and Cosmetic Act
(C-3 Misbranding: Drug and Devices)
A.O. 61 s. 1968
142
Regulation Part C-9:
Drugs: Registration of drugs and
pharmaceutical Specialties
A.O. 101 s. 1969
143
Regulation Part C-1
Drug labeling:
Prescription drug
Label symbol
A.O. 109 s. 1969
144
Regulation Part C-10
* Statement of Lot number
* Expiration date
* Registration number
* Storage conditions of pharmaceutical
Specialties
A.O. 126 s. 1970
145
Regulation Part D-4:
Cosmetic: Registration of Cosmetic
Specialties
A.O. 150 s. 1971
146
Regulation Part C-3.2:
Drug: Prohibition of the use of more than
one name for a given formulation
A.O. 132 s. 1970
147
Regulation Part C-7
Drug and Devices:
Certification of Antibiotics
A.O. 151 s. 1971
148
Restricted Use of Boric acid and Sodium
Borate (Borax)
A.O. 195 s. 1973
149
CGMP in Manufacture, Processing, Packing and
Holding
A.O. 220 s. 1974
150
Ban on the Use of Chloroform
(Trichloromethane)
A.O. 341 s. 1978
151
Banning Tetracycline for Children under 8 yrs.
Old
A.O. 342 s. 1978
152
The need and role for a MEDICAL
DIRECTOR in the Pharmaceutical
Industries
A.O. 34 s. 1979
153
Restriction on the use of several BRAND
NAMES for formulation of a drug or
pharmaceutical specialty
A.O. 38 s. 1979
154
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
PHARMACEUTICAL QUALITY SYSTEM
155
CAPA
Corrective Action and Preventive
Action
156
damage to health, including the damage that can occur from loss of
product quality or availability.
Harm
157
the potential source of harm (ISO/IEC Guide 51)
Hazard
158
all phases in the life of the product from the initial
development through marketing until the product’s discontinuation.
Product lifecycle
159
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.)
Quality
160
a systematic process for the assessment, control,
communication and review of risks to the quality of the drug (medicinal) product
across the product lifecycle
Quality Risk Management
161
the combination of the probability of occurrence of harm and the severity
of that harm
Risk
