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DDS > WEEK 4 (CHAPTER 3) > Flashcards

WEEK 4 (CHAPTER 3) Flashcards

1
Q
  • regulations are established by FDA
  • To ensure that minimum standards are met for drug product quality in the US
  • this regulations establish requirements for all aspects of pharmaceutical manufacture
  • ensure compliance-FDA inspects
A

CURRENT GOOD MANUFACTURING
PRACTICE (cGMP)

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2
Q
  • Requirement for “Current Good Manufacturing Practice
    for Finished Pharmaceuticals”
  • Additional cGMP requirements for biologic products,
    medicated articles and medical device
A

CODE OF FEDERAL REGULATIONS

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3
Q

Contains the minimum requirements for the preparation of finished pharmaceutical product

A

CGMP FOR FINISHED
PHARMACEUTICALS

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4
Q

-Any component that is intended to furnish pharmacologic activity

A

Active ingredients

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5
Q

A specific quantity of a drug uniform specified quality produced accdg to a single manufacturing order

A

Batch

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6
Q

The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the batch concerned

A

Batchwise control

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7
Q

Documented testimony by qualified authorities that a system qualification has been performed appropriately

A

Certification

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8
Q

Determination through inspection in which a manufacturer is acting in accordance to the regulation

A

Compliance

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9
Q

A finished form that contains active or inactive ingredients

A

Drug product

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10
Q

Any other component other than the active ingredient in a drug product

A

Inactive ingredient

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11
Q

Any portion of a batch having uniform specified quality

A

Lot

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12
Q

Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug may be determined

A

Lot number, control number, batch number

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13
Q

provision to all concerned the evidence needed to establish confidence that the activities relating to quality
are performed adequately

A

Quality assurance

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14
Q

A documented activity performed in accordance with established procedures to ensure compliance

A

Quality Audit

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15
Q

The regulatory process through which industry measures actual quality performance, compares it with
standards, and acts on the difference

A

Quality control

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16
Q

an area that is marked, designated or set aside for the holding of incoming components prior to acceptance
testing and qualification for use

A

Quarantined

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17
Q

concentration of a drug substance per unit dose or volume

A

Strength

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18
Q

document evidence that a system does what it purports to do

A

Validation

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19
Q
  • documented evidence that a process does what it purports to do
A

Process validation

20
Q
  • a prospective experimental plan to produce documented evidence that the system has been validated
A

Validation protocol

21
Q

Deals with the responsibilities of the quality control unit, employees, and consultants

  • All personnel engage in the manufacture required to have the education, training, and experience to fulfill the
    assigned responsibility
A

Organization and Personnel

22
Q

authority and responsibility for all
functions that may affect product quality

A

Quality control unit

23
Q

must be planned for easy cleaning, maintenance, and freedom from congestion and traffic

A

Buildings

24
Q

used for the manufacture, processing, packaging, holding, testing, or
control of drug and cosmetics

A

Equipment

25
Q

required for production and process controls to ensure that the drug products have the correct identity, strength, quality, and purity

A

Written procedures

26
Q

destroyed

A

Obsolete labels

27
Q
  • Determined by appropriate
    stability testing
  • Assure that a drug product meets
    applicable standards of identity,
    strength, quality, and purity at the
    time of use
A

Expiration dating

28
Q
  • “one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected
    to provide visible evidence to consumers that tampering has occurred”
A

TAMPER-EVIDENT PACKAGING

29
Q

important to maintain the physical and chemical stability of the product by being an effective barrier to light, moisture, oxygen, bacteria, volatiles and etc

A

Packaging

30
Q

Accdg to USP: holds the article and it may come in direct contact with the article

  • must not interact physically or chemically with the drug so as to alter strength, quality or purity
A

Container

31
Q
  • protects the contents from extraneous solids and loss of the article under ordinary conditions of handling, shipment, storage and distributions.
A

Well-closed container

32
Q
  • protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article under ordinary conditions
A

Tight container

33
Q

impervious to air or any other gas under ordinary conditions

A

Hermetic container

34
Q

one that holds a quantity of drug intended as a single dose

A

Single dose container

35
Q
  • hermetic container that permits
    withdrawal of successive portions of contents without changing
    the strength or endangering the quality or purity
A

Multiple dose container

36
Q
  • amber glass/opaque
    plastics will reduce light transmission
    sufficiently to protect a light sensitive product
A

Light-resistant containers

37
Q

Highly resistant Borosilicate Glass
SiO2 + B2O3

A

TYPE I

37
Q
A
38
Q

Treated Soda Lime Glass
Na2O + CaO
SO2 Treatment

A

TYPE II

39
Q

Soda Lime Glass for Dry Products
Na2O + CaO

A

TYPE III

40
Q

General Purpose Soda Lime Glass
Na2O + CaO
Non parenteral

A

TYPE NP

41
Q

High molecular polymers such as Polyethylene, Polystyrene,
Polypropylene, Polyvinyl chloride

A

Plastic containers

42
Q

-binding of drug molecule to the
polymer material

A

Sorption (ab or ad)

43
Q
  • describe the movement of components of a container into the contents
A

Leaching

44
Q

binding of molecules to polymer
materials includes both adsorption and absorption.

A

Sorption

45
Q

STORAGE

A
  • Freezer: -25ºC and -10ºC
  • Cold: Any temperature not exceeding 8ºC
  • Cool: 18ºCand 15ºC
  • Room temperature: temperature prevailing in a working area
  • Controlled Room temp: 20ºC to 25ºC
  • Warm: 30ºC and 40ºC
  • Excessive Heat: Above 40ºC

DDS (10 decks)

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