Concepts for Compounding Flashcards by Morenike Olaosebikan

STAR

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

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Vision Ready

Plan Work - Work Plan

Plan Market - Market Plan

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Quality Driven

Quality, Risk, Verification

SOPs

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Balance Concept

Stability - Suitability

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Appropriate Compromise

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

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Efficiency and Effectiveness

Do the Right thing Right

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Competency and Compliance

Knowledge Base & Learned skill set is your base

Practice for growth

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Best Practice

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

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Rationale for Compounding

Concept: STAR

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

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Compounding Considerations

Concept: STAR

> 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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Continuous Quality Improvement plan

Concept: Quality Driven

Compound
Personnel
Environment & Others with direct/ indirect contact

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Quality Initiatives

Concept: Quality Driven

Quality Assurance
Quality Control
Quality Improvement

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Quality Assurance

Concept: Quality Driven

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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Quality Control

Concept: Quality Driven

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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Quality Improvement

Concept: Quality Driven

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

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Quality Assurance VS Quality Control

Concept: Quality Driven

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

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Concept: Balance

Neglect: Instability
Variable: Stability

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Solubility & Ionization

Concept: Balance

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

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Ability to Suspend

Concept: Balance

Neglect: Inconsistent Dosing
Variable: Stability

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Oxidation and Reduction

Concept: Balance

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Neglect: Drug Degradation
Variable: Stability

Photosensitivity

Concept: Balance

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Neglect: Drug Degradation sometimes catalytic
Variable: Stability

Phase inversion

Concept: Balance

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Neglect: Drug concentration too high
Variable: Stability

Adsorption & Reactivity

Concept: Balance

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Neglect: Interactions with Container
Variable: Stability

Temperature Sensitivity

Concept: Balance

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Neglect: Decomposition if heat labile
Variable: Stability

Hygroscopicity | Concept: Balance

Neglect: Dosage form integrity compromise Variable: Stability

Hydrolysis | Concept: Balance

Neglect: Microbial proliferation Variable: Stability

Microbial Proliferation | Concept: Balance

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

Polarity | Concept: Balance

Neglect: Phase Separation Variable: Stability

Tonicity | Concept: Balance

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

Buffering Capacity | Concept: Balance

Neglect: Ability to pH moderate Variable: Stability

Taste | Concept: Balance