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PSMB > ANALYSIS 2 | Part 1 > Flashcards

ANALYSIS 2 | Part 1 Flashcards

1
Q

The basic document from where the master formula and batch
production records are based

A

MANUFACTURING MONOGRAPH

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2
Q

CGMP OR AO___

A

AO No. 220 s. 1974

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3
Q

The document which provides the basis for accepting the quality of each and every component used in the manufacture of the
product in accordance with the specifications and methods

A

QUALITY CONTROL MONOGRAPHS

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4
Q

The document generated to explain in detail the reason behind a
procedure and proper sequence of steps to be done, and how
equipment are to be operated for maximum performance

A

STANDARD OPERATING PROCEDURES

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5
Q

-The original document used as the key in the manufacture of
products
-Being the prototype, it is kept in a secured documentation room,

A

MASTER FORMULA RECORD

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6
Q

is an accurate reproduction of the master formula record
-After being used as the guide to production and actual data of what has been done are recorded therein

A

BATCH REPRODUCTION RECORD

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7
Q

Specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture

A

BATCH

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8
Q

A batch, a portion of a batch, or a
combination of batches

A

LOT

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9
Q

-Should be identified as such on the label
- Differences in format and content of batch
production records from

A

Control codes

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10
Q

Any distinctive combination of marking, letters, or numbers by which the history of the manufacture and control of a batch or lot of a product can be determined (e.g., for documentation and
product recall)

A

BATCH NUMBER, LOT NUMBER, CONTROL NUMBER

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11
Q

tests are performed to
determine if the product meets specifications throughout the
entire processing and particularly during critical stages of manufcaturing

A

IN-PROCESS CONTROL

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12
Q

Minimum attributes common to general categories of products are enumerated below. Where necessary, some of these tests are performed during processing (IPQC) of the product and
repeated in the final product

A

CONTROL TESTS

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13
Q

All operations, including filling and labelling, which a bulk product
has to undergo in order to become a finished product

A

PACKAGING

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14
Q

Tool for determining error and wastage, as well by comparing
actual yield (AY) and theoretical yield (TY)

A

MATERIAL RECONCILIATION

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15
Q

-The procuring, purchasing, holding, storing, selling, supplying,
importing, exporting, or movement of pharmaceutical production

A

DISTRIBUTION CONTROL

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16
Q

_____ and ____ should be withheld until batch
certification from FDA is received

A

Antibiotics and Insulin

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17
Q

Aids in the monitoring of stocks either received or dispatched

A

STOCK CARDS

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18
Q

-The ability of a particular formulation in a specific container or closure system to remain within its physical, chemical, microbiological, therapeutic, and toxicological specifications or best state

A

STABILITY

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19
Q

 The period of stability of a preparation is the time from the date
of manufacture of the formulation until its chemical or biological act and is _____ of the labelled potency

A

NLT 90%

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20
Q

Duration of time during which the drug prep will remain stable

A

SHELF LIFE

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21
Q

Limits the period during which a preparation may be expected to have its labeled potency

A

EXPIRATION DATE

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22
Q

TYPE OF STABILITY STUDIES
For 3 mos, use of exaggerated conditions

A

SHORT TERM / ACCELERATED STABILITY STUDIES

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23
Q

TYPE OF STABILITY STUDIES
For 2 YEARS, normal conditions, makes use of climatic zone

A

LONG TERM / REAL TIME STABILITY STUDIES

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24
Q

TYPE OF STABILITY STUDIES
For 6-12 months, involves 10 deg increment of those in ASS

A

STRESS TESTS

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25
Q

The voluntary introduction of a specific excess during the manufacture of pharmaceutical forms of medicaments that are
unstable by nature

A

OVERAGE

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26
Q

ALLOWABLE OVERAGE
Dry Dosage Form

A

NMT 15%

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27
Q

ALLOWABLE OVERAGE
Liquid Dosage Form

A

NMT 20%

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28
Q

ALLOWABLE OVERAGE
Ointment
Suppositories
Aerosols
Creams
Foams

A

NMT 25%

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29
Q

ICH meaning

A

International Council for Harmonization

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30
Q
  1. STERILITY TEST
    A. Primary Method
A

Membrane Filtration

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31
Q
  1. STERILITY TEST
    B. Direct Transfer
A

DIRECT INOCULATION

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32
Q

Culture Media
-fungi, aerobic bacteria

A

SOYBEAN CASEIN DIGEST (TRYPTONE SOYA BROTH)

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33
Q

Culture Media
-anaerobes

A

FLUIDTHIOGLYCOLLATE

34
Q
  1. TEST FOR PYROGENS
    A. Bacterial Endotoxin Test
A

LAL Reagent

35
Q

Two Methods of BET

A
  1. Gel Clot Formation & Turbidimetric Method
  2. (+) Formation of gel/dev of color presence of material endotoxins
36
Q

Pyrogen Test
Dose:

A

10mL per Kg unless otherwise specified

37
Q

Corticotrophin inj

A

Rat (either male or female)

38
Q

COD Liver Oil

A

Rachitic rat

39
Q

Vasopressin Inj

A

Male Rat

40
Q

Chorionic Gonadotropin

A

Female rat (2-23 days old)

41
Q

Digitalis

A

Pigeon

42
Q

Glucagon

A

Cat

43
Q

Oxytocin

A

Chicken

44
Q

Heparin and Protamine

A

Sheep Blood Plasma

45
Q

Parathyroid Inj

A

DOG

46
Q

Insulin, Metocurine & Tubocurarine Inj.

A

Rabbit

47
Q

Leaker’s Test
Dye:

A

1% Methylene Blue

48
Q

Combination of attributes or characteristics of a product which, when compared to standard, serves as a basis for measuring uniformity of the product and determines its degree of acceptability

A

QUALITY

49
Q

Refers to measure or step used to prevent or eliminate drug risks/hazards to make it safe and effective

A

CONTROL

50
Q

Is a tool, which gives the assurance that a product conforms to standards and specifications through the system of inspection, analysis and action

A

QUALITY CONTROL

51
Q

sum total of organized activities performed with the intent to ensure that all active pharmaceutical ingredients are of the quality required for their intended use

A

QUALITY ASSURANCE

52
Q

process inside an organization with the aim to improve its performance by learning about good practices for primary and/or support processes through looking at those processes in other…

A

BENCHMARKING

53
Q

A management approach for an organization centered on quality…

A

TOTAL QUALITY MANAGEMENT

54
Q

Quality assessment with an attached judgement that the evaluated unit (programme or organization) is good enough to have the right to exist in a particular system

A

ACCREDITATION

55
Q

A voluntary, non-treaty federation of standards setting bodies of some 130 countries.

A

ISO International Organization for Standardization

56
Q

An undesirable characteristics of a product

A

DEFECTS

57
Q

Unit of a product which contains one or more defects

A

DEFECTIVE

58
Q

are ingredients intended for use in the manufacture of drugs and cosmetics, including those that may not appear in the final product

A

RAW MATERIALS

59
Q

Assigned to each batch received from the supplier

A

RECEIVING NUMBER

60
Q

Completed upon receipt of the material
Concerns the: QC, warehouse, purchasing, accounting

A

RECEIVING TALLY REPORT

61
Q

Re-Assay Date
Vitamins, Flavorants

A

6 months

62
Q

Re-Assay Date
Active Ingredients, Dyes

A

12 months

63
Q

Re-Assay Date
Excipients

A

24 months

64
Q

QC TEST FOR DF
-determines the material type, assembly, special properties and integrity

A

PACKAGING TEST

65
Q

QC TEST FOR DF
-determines the physical & chemical reactions particular for the compound, gives the gross physical appearance

A

IDENTIFICATION TEST

66
Q

QC TEST FOR DF
-determines presence of impurities: gross, chemical, and biological

A

LIMIT TESTS

67
Q

QC TEST FOR DF
-determines conformance of DF when compared to label claim; this may be instrumental, chemical, or biological

A

ASSAYING

68
Q

QC TEST FOR DF
-tests for properties, fx of particular DF

A

DF-Specific Test

69
Q

Test for electronic Particle Counters

A

LIGHT OBSTRUCTION PARTICLE COUNT TEST

70
Q

Test for Membrane Filtration

A

MICROSCOPIC PARTICLE COUNT TEST

71
Q

Ideal size of particles

A

2um

72
Q

amount of force necessary to redisperse

A

REDISPERABILITY

73
Q

determines the repulsive forces bet particles

A

ZETA POTENTIAL

74
Q

 Contains 50 mg or more of an active ingredient comprising 50%
or more by weight of the formulation

A

WEIGHT VARIATION

75
Q

Perform assay from pooled sample and calculate individual content of active ingredient in each of the 10 units

A

CONTENT UNIFORMITY

76
Q

Defined as the state in which any residue of the unit remain on
the screen of the test apparatus or adhering to the lower surface
of the disk, if used, is a soft mass having no palpably firm core

A

COMPLETE DISINTEGRATION

77
Q

Determine compliance with the dissolution paramaters for dosage form administered orally

A

DISSOLUTION

78
Q

Friability maximum weight loss

A

FRIABILITY

79
Q

Tablets must withstand the rigors of handling and transportation
experience in the manufacturing plant

A

HARDNESS

80
Q

Measures the mechanical integrity of the tablet. It is the force that required to cause them to fail

A

BREAKING FORCE

81
Q

Crushing Strength

A

HARDNESS

PSMB (20 decks)

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