Concepts for Compounding Flashcards
STAR
Morally, Ethically, Legally, Politically & Clinically sound decision making
Vision Ready
Plan Work - Work Plan
Plan Market - Market Plan
Quality Driven
Quality, Risk, Verification
SOPs
Balance Concept
Stability - Suitability
Appropriate Compromise
Change route/ delivery system - Ensure that stability/ suitability compromise is safe and acceptable
Efficiency and Effectiveness
Do the Right thing Right
Competency and Compliance
Knowledge Base & Learned skill set is your base
Practice for growth
Best Practice
Practical strategies for implementing required standards - Maintain/ improve operations & quality.
Save time and money. Reduce risk.
Rationale for Compounding
Concept: STAR
> Commercial availability.
Dose, dosage form, content, administration method.
Excipient Allergy
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
Continuous Quality Improvement plan
Concept: Quality Driven
- Compound
- Personnel
- Environment & Others with direct/ indirect contact
Quality Initiatives
Concept: Quality Driven
Quality Assurance
Quality Control
Quality Improvement
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
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.
Quality Improvement
Concept: Quality Driven
A systematic, formal approach to the analysis of practice performance and efforts to improve performance.
Quality Assurance VS Quality Control
Concept: Quality Driven
Prevent vs Identify
Proactive vs Reactive
Process based vs. Product based
Manage vs Verify
PH
Concept: Balance
Neglect: Instability
Variable: Stability
Solubility & Ionization
Concept: Balance
Neglect: Precipitation leads to under/ over dose
Variable: Stability
Ability to Suspend
Concept: Balance
Neglect: Inconsistent Dosing
Variable: Stability
Oxidation and Reduction
Concept: Balance
Neglect: Drug Degradation
Variable: Stability
Photosensitivity
Concept: Balance
Neglect: Drug Degradation sometimes catalytic
Variable: Stability
Phase inversion
Concept: Balance
Neglect: Drug concentration too high
Variable: Stability
Adsorption & Reactivity
Concept: Balance
Neglect: Interactions with Container
Variable: Stability
Temperature Sensitivity
Concept: Balance
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
Neglect: Non-Compliance
Variable: Suitability
Texture
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Smell
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Color
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Flavor
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Consistency
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Washable
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Ease of Use
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Chemical/ Physiological Sensitivities
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Pourability
Concept: Balance
Neglect: Non-Compliance
Variable: Suitability
Tissue (Skin) Damage
Neglect: Potential for new ADE
Variable: Suitability
Customization
Concept: Appropriate Compromise
Balance Stability with Suitability with Compliance with Compatibility
Efficiency
Concept: Efficiency & Effectiveness
Doing The Thing Right
Effectiveness
Concept: Efficiency & Effectiveness
Doing the Right Thing
Competency
Concept: Competency & Compliance
Initial and ongoing training
Compliance
Concept: Competency & Compliance
Actual behaviour and ability to maintain a level of performance
Compliance Indicators
Concept: Competency & Compliance
Set of chronological steps that make up a task
Risk Assessment
Concept: Competency & Compliance
Compliance indicator that breaks down tasks to their smallest components
Best Practices applies another concept by asking the question, “are you doing the right thing right?”
Efficiency and Effectiveness
