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Pharm Ana 1 LEC > (Prelim) Quality Control [Pharm Ana 1 LEC] > Flashcards

(Prelim) Quality Control [Pharm Ana 1 LEC] Flashcards

1
Q

Types of Analysis

A

A. Based on Sample Size
B. Based on Extent of Determination
C. Based on Nature of Methods

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2
Q

Based on Sample Size

A

Ultramicro
Micro
Semi-micro
Macro

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3
Q

Ultramicro

A

<1 mg

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4
Q

Micro

A

1 - 10mg

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5
Q

Semi-micro

A

10 - 100mg

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6
Q

BASED ON EXTENT OF DETERMINATION

A
  • Proximate
  • Ultimate
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6
Q

Macro

A

100 - 1000 mg

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7
Q

Proximate

A

total amount of a class or group of
active constituents

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8
Q

Ultimate

A

amount of a single chemical species
in a sample

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9
Q

Classical

A

Titrimetric, Gravimetry

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9
Q

BASED ON NATURE OF METHODS

A
  • Classical
  • Instrumental
  • Miscellaneous
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10
Q

Miscellaneous

A

Water content, Ash content,
Acid value, Iodine value, etc

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11
Q

USP/NF

A

A book of pharmacopoeial standard.

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11
Q

Instrumental

A

Spectrometry, Polarimetry

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11
Q

USP/NF

A

Contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements

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12
Q

General Principles in Quality Control (Standards and Monographs)

A

A. USP/NF
B. Parts of Monograph

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13
Q

General Principles in Quality Control (Accuracy,
Precision, and Errors)

A

A. Accuracy (Validity)
B. Precision (Reliability)
C. Types of Errors
D. Defects

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14
Q

The degree to which information matches true or accepted value

A

ACCURACY (VALIDITY)

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15
Q

Degree to which the results of a measurement
estimated underlying true value.

A

ACCURACY (VALIDITY)

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16
Q

An issue pertaining to the quality of data and the number of errors contained in a dataset

A

ACCURACY (VALIDITY)

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17
Q

Degree to which measurements fluctuates
around the central measurement

A

PRECISION (RELIABILITY)

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18
Q

Reproducibility or repeatability

A

PRECISION (RELIABILITY)

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19
Q

TYPES OF ERRORS

A

● INDETERMINATE ERRORS
● DETERMINATE ERRORS

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20
Q

INDETERMINATE ERRORS

A

(Random/Accidental error)

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21
Q

DETERMINATE ERRORS

A

(Systematic/Constant)

22
Q

Sources of Variation

A
  • Materials
  • Machines
  • Methods
  • Men
23
Q

Example of Materials

A
  1. Variation between suppliers of same
    substance.
  2. Variation between batches from same
    supplier.
  3. Variation within a batch.
24
Q

Examples of Machines

A
  1. Variation of equipment for the same
    process.
  2. Difference in adjustment of equipment.
  3. Aging and improper care
25
Q

Examples of Men

A
  1. Improper working conditions.
  2. Inadequate training and
    understanding.
  3. Dishonesty, fatigue, and carelessness.
26
Q

Examples of Methods

A
  1. Inexact procedures.
  2. Inadequate procedures
  3. Negligence by chance.
27
Q

undesired characteristic of a product

A

Defects

27
Q

failure to conform to specification

A

Defects

28
Q

Types of Defects

A

▸ According to measurability
▸ According to seriousness or gravity
▸ According to nature

29
Q

According to measurability

A

⬩ Variable defect
⬩ Attribute defect

30
Q

According to seriousness or gravity

A

⬩ Critical defect
⬩ Major defect
⬩ Minordefect

31
Q

According to nature

A

⬩ Ocular defect
⬩ Internal defect
⬩ Performance defect

32
Q

A substance or bulk pharmaceutical chemical
that is intended to furnish pharmacological activity.

A

Active ingredient

32
Q

A material that has either been contaminated with a foreign substance or not manufactures using good manufacturing practices.

A

Adulterated substance

33
Q

provide an exact result, which allows an accurate statement on the content or potency of the analyte in the sample.

A

Assay

34
Q

A distinctive combination of numbers or
letters from which the complete history of the manufacture, processing, packing, coding, and distribution of a batch can be determined

A

Batch number (Lot number)

34
Q

A defined quantity of raw material, intermediate material, packaging components, or final products processed so that it expected to be homogenous.

A

Batch (Lot)

35
Q

A standard operating procedure (SOP) describing the details of assigning batch numbers

A

Batch numbering system

36
Q

The determination is to be conducted using
the same quantities of the same reagents treated in the same manner as the solution or mixture containing the portion of the
the substance under assay or test, but with the substance itself omitted

A

Blank Determination

37
Q

Documentation that provides the history of a batch from the raw material stage to completion of the batch or lot.

A

Batch record

38
Q

The use of tightly closed container of suitable size and design that maintains an atmosphere of low moisture content by means of silica gel or other suitable desiccant.

A

Desiccator

38
Q

regulatory guidelines promulgated by the FDA which made the strongest impact on the drug and cosmetic industry. As the word implies current means dynamic, changing as the occasion arises (the need for technical improvement and for greater protection of the consumer)

A

CGMP- (Current Good Manufacturing Practice)

39
Q

is one that maintains the low-moisture atmosphere at a reduced pressure of not more than 20 mm of mercury or at the pressure designated in the individual monograph.

A

Vacuum Desiccator

40
Q

two consecutive weighting do not differ by more than 0.5 mg/g of substances taken for the determination, the second weighing following an additional hour of drying

A

Dried to constant weight

40
Q

The date beyond which the product may
no longer conform to the relevant
specifications

A

Expiration date

41
Q

This term indicates a quantity not
exceeding 0.50 mcg

A

Negligible

42
Q

Laboratory equipment designed to limit
person’s exposure to hazardous fumes

A

Fume Hood

43
Q

The number of linear openings per
square inch.

A

Mesh

44
Q

The containers, closures, and labels
employed in the packaging of the product

A

Packaging Material

45
Q

A piece of a soft rubber tubing fitted to the
end of a glass rod

A

Policeman

46
Q

A measure of reproducibility of data
within a series of results

A

Precision

47
Q

The status of any material isolated
physically or by other effective means
while awaiting a decision on its use

A

Quarantine

48
Q

Finished products sent back to the
manufacturer

A

Returned Products

49
Q

The length of time during which the
product exhibits stability

A

Shelf Life

50
Q

The quality parameters that serve as a
basis for quality evaluation and to which
the products or materials must conform

A

Specifications

51
Q

Ability to assess unequivocally the
analyte in the presence of components
that maybe expected to be present such
as impurities, degradation products, and
matrix components

A

Specificity

Pharm Ana 1 LEC (5 decks)

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