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Compounding Training > Concepts for Compounding > Flashcards

Concepts for Compounding Flashcards

1
Q

STAR

A

Morally, Ethically, Legally, Politically & Clinically sound decision making

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2
Q

Vision Ready

A

Plan Work - Work Plan

Plan Market - Market Plan

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3
Q

Quality Driven

A

Quality, Risk, Verification

SOPs

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4
Q

Balance Concept

A

Stability - Suitability

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5
Q

Appropriate Compromise

A

Change route/ delivery system - Ensure that stability/ suitability compromise is safe and acceptable

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6
Q

Efficiency and Effectiveness

A

Do the Right thing Right

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7
Q

Competency and Compliance

A

Knowledge Base & Learned skill set is your base

Practice for growth

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8
Q

Best Practice

A

Practical strategies for implementing required standards - Maintain/ improve operations & quality.
Save time and money. Reduce risk.

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9
Q

Rationale for Compounding

Concept: STAR

A

> Commercial availability.
Dose, dosage form, content, administration method.
Excipient Allergy

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10
Q

Compounding Considerations

Concept: STAR

A 
> BUD
> Duration of Therapy vs. BUD
> Efficacy, Reliability, Validity 
> QA and QC
> Documentation in association & support
> Availability of support documentation
> Criteria for assessing patient outcome
> Pharmacokinetic drug assessment vs. bioequivalence
> Legislative/ regulatory restrictions.
> Appropriateness of Primary & Secondary Engineering controls
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11
Q

Continuous Quality Improvement plan

Concept: Quality Driven

A
  • Compound
  • Personnel
  • Environment & Others with direct/ indirect contact
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12
Q

Quality Initiatives

Concept: Quality Driven

A

Quality Assurance
Quality Control
Quality Improvement

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13
Q

Quality Assurance

Concept: Quality Driven

A

A way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.

Focused on providing confidence that quality requirements will be fulfilled

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14
Q

Quality Control

Concept: Quality Driven

A

Procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer.

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15
Q

Quality Improvement

Concept: Quality Driven

A

A systematic, formal approach to the analysis of practice performance and efforts to improve performance.

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16
Q

Quality Assurance VS Quality Control

Concept: Quality Driven

A

Prevent vs Identify
Proactive vs Reactive
Process based vs. Product based
Manage vs Verify

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17
Q

PH

Concept: Balance

A

Neglect: Instability
Variable: Stability

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18
Q

Solubility & Ionization

Concept: Balance

A

Neglect: Precipitation leads to under/ over dose
Variable: Stability

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19
Q

Ability to Suspend

Concept: Balance

A

Neglect: Inconsistent Dosing
Variable: Stability

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20
Q

Oxidation and Reduction

Concept: Balance

A

Neglect: Drug Degradation
Variable: Stability

21
Q

Photosensitivity

Concept: Balance

A

Neglect: Drug Degradation sometimes catalytic
Variable: Stability

22
Q

Phase inversion

Concept: Balance

A

Neglect: Drug concentration too high
Variable: Stability

23
Q

Adsorption & Reactivity

Concept: Balance

A

Neglect: Interactions with Container
Variable: Stability

24
Q

Temperature Sensitivity

Concept: Balance

A

Neglect: Decomposition if heat labile
Variable: Stability

25
Q

Hygroscopicity

Concept: Balance

A

Neglect: Dosage form integrity compromise
Variable: Stability

26
Q

Hydrolysis

Concept: Balance

A

Neglect: Microbial proliferation
Variable: Stability

27
Q

Microbial Proliferation

Concept: Balance

A

Neglect: Increases the risk of harm to patient
Variable: Stability

28
Q

Polarity

Concept: Balance

A

Neglect: Phase Separation
Variable: Stability

29
Q

Tonicity

Concept: Balance

A

Neglect: Relationship with hyper/hypo - tonicity in body
Variable: Stability

30
Q

Buffering Capacity

Concept: Balance

A

Neglect: Ability to pH moderate
Variable: Stability

31
Q

Taste

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

32
Q

Texture

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

33
Q

Smell

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

34
Q

Color

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

35
Q

Flavor

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

36
Q

Consistency

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

37
Q

Washable

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

38
Q

Ease of Use

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

39
Q

Chemical/ Physiological Sensitivities

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

40
Q

Pourability

Concept: Balance

A

Neglect: Non-Compliance
Variable: Suitability

41
Q

Tissue (Skin) Damage

A

Neglect: Potential for new ADE
Variable: Suitability

42
Q

Customization

Concept: Appropriate Compromise

A

Balance Stability with Suitability with Compliance with Compatibility

43
Q

Efficiency

Concept: Efficiency & Effectiveness

A

Doing The Thing Right

44
Q

Effectiveness

Concept: Efficiency & Effectiveness

A

Doing the Right Thing

45
Q

Competency

Concept: Competency & Compliance

A

Initial and ongoing training

46
Q

Compliance

Concept: Competency & Compliance

A

Actual behaviour and ability to maintain a level of performance

47
Q

Compliance Indicators

Concept: Competency & Compliance

A

Set of chronological steps that make up a task

48
Q

Risk Assessment

Concept: Competency & Compliance

A

Compliance indicator that breaks down tasks to their smallest components

49
Q

Best Practices applies another concept by asking the question, “are you doing the right thing right?”

A

Efficiency and Effectiveness

Compounding Training (4 decks)

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