Quality Assurance and Risk Assessment

  • Differentiate between qualification, quality assurance and quality control
  • Summarize quality assurance and quality control program requirements
  • Explain quality assurance, quality control, and corrective and preventive action measures applicable to…    
    • Personnel 
    • Environment
    • Inventory control 
    • Compounded sterile preparation 
  • Apply best practice principles to sterile compounding
  • Apply risk management approaches to sterile compounding
    • Ishikawa Method
    • Failure Mode and Effects Analysis Method

Immediate-use CSP 

  • Define immediate-use compounding
  • Identify exclusion criteria of immediate-use compounding
  • Explain immediate-use aseptic techniques
  • Outline inspection, labeling and documentation requirements of immediate-use compounding

Category 1 CSPs

  • Discuss parameters of practice (aka conditions) surrounding Category 1 Compounded Sterile Preparations
    • Personnel competency
    • Facility design and certification
    • Environmental quality assurance and quality control
    • Compounded Sterile Preparation quality assurance and quality control

Category 2 CSPs

  • Discuss parameters of practice (aka conditions) surrounding Category 2 Compounded Sterile Preparation
    • Personnel competency
    • Facility design and certification
    • Environmental quality assurance and quality control
    • Compounded Sterile Preparation quality assurance and quality control

Category 3 CSPs

  • Discuss parameters of practice (aka conditions) surrounding Category 3 Compounded Sterile Preparations
    • Personnel competency
    • Facility design and certification/recertification
    • Environmental quality assurance and quality control
    • Compounded Sterile Preparation quality assurance and quality control

Cleaning and Disinfecting

  • Identify personnel roles and responsibilities
  • List standard operating procedure requirements 
  • Discuss cleaning and disinfecting agent selection
  • List cleaning and disinfecting supplies 
  • Identify cleaning and disinfecting procedure frequencies
  • Explain best practice cleaning and disinfecting procedures
    • Primary engineering controls
    • Secondary engineering controls
    • Equipment and supplies

Depyrogenation

  • Explain the depyrogenation process and its operational parameters
  • Describe depyrogenation qualification and cycle validation tests
    • Endotoxin challenge vials (endotoxin indicators)
  • Describe temperature mapping procedures to verify uniform heat distribution
  • Describe the depyrogenation by rinsing process

Total Airborne Particle Sampling

  • Discuss the purpose of total airborne particle sampling
  • Develop a site sampling plan
  • Identify circumstances for which sampling is required
  • Identify action levels of ISO classified rooms
  • Identify trends over time while results fall within acceptable levels
  • List possible corrective actions

Master Formulation and Compounding Record 

  • Identify Master Formulation Record requirements
  • Identify Compounding Record requirements
  • Outline how to document formulation records 
  • Differentiate between record types
    • Process Development Record
    • Stock Formulation Record
    • Batch Formulation Record
    • Master Formulation Record
    • Compounding Record
  • Identify formulation overage requirements

Beyond-Use Dating

  • List factors that affect beyond-use dates    
  • Establish beyond-use dates of Category 1, 2 and 3 Compounded Sterile Preparations
  • Establish special circumstance formulation beyond-use dates
    • Multiple dose
    • Non-preserved
    • Aqueous topical
    • Topical ophthalmic

Aseptic Techniques (Non-HD & HD)

  • Define parameters of aseptic technique
  • Discuss the impact of the human body as a source of contamination
  • Employ compliance indicators to assess aseptic technique applications
  • Apply appropriate body position and posture while performing aseptic manipulations
  • Organize the direct compounding area and surrounding area of the primary engineering control
  • Discuss the movement and placement of equipment and supplies in classified environments
  • Show correct methods of performing commonly used aseptic manipulations

Calculation Basics

  • Manipulate numbers and units of measure
    • Metric system conversions
    • Rules of notation
    • Rounding fractional components of decimals
    • Expressing percent error
    • Density, area, and volume calculations
    • Alligation method

Concentration and Strength

  • Manipulate concentration, strength, and percent expressions 

Adjusting MFRs and CRs

  • Perform base-to-salt and salt-to-base conversions
  • Interpret a USP Monograph
  • Interpret a Certificate of Analysis
  • Calculate Certificate of Analysis adjustments
  • Calculate overage adjustments

Osmolarity and Isotonicity

  • Calculate the osmolarity of a solution
  • Perform isotonicity adjustments

Endotoxin Limits

  • Calculate endotoxin limits

Filtration Sterilization

  • Identify factors that affect filtration sterilization
  • Identify procedures that affect filtration sterilization
  • Indicate filter membrane porosity and function
  • Differentiate between pre-filtration and filtration sterilization
  • Discuss filtration process strategies
    • Single sterilizing filter
    • Pre-filter and sterilizing filter in series
    • Two sterilizing filters in series
  • Explain post-filtration integrity testing
  • Interpret bubble point test results
  • Explain failed bubble point test results
  • Restate filtration sterilization procedures
    • Ampule withdrawal
    • Single syringe filter use
    • Dual syringe filter use
    • Pump with a single filter
    • Performing a bubble point test
  • Apply logic in selecting an appropriate filter(s) for use in clinical practice

Steam Heat Sterilization

  • Explain the steam heat sterilization cycle process
  • Describe steam heat sterilization cycle validation tests
    • Biological indicators
    • Physicochemical indicators
  • Restate incubation parameters of biological indicator validation
  • Interpret the results of the biological indicator
  • Relate failed cycles to corrective action and preventive action

Dry Heat Sterilization

  • Explain the dry heat sterilization cycle process
  • Describe dry heat sterilization cycle validation tests
    • Biological indicators
    • Physicochemical indicators
  • Restate incubation parameters of biological indicator validation
  • Interpret the results of the biological indicator

Release Inspections and Testing

  • Discuss visual inspection criteria of the compounded sterile preparation and container closure
  • List release inspection and testing procedures
  • Explain designated person or assigned compounding pharmacist responsibilities regarding release testing

Sterility Testing

  • Discuss the purpose of compounded sterile preparation sterility testing
  • Describe structural, functional, and operational parameters of sterility testing
  • Summarize key elements of the sterility test
    • Sample selection
    • Membrane filtration method
    • Direct inoculation method
    • Method suitability
  • Explain sterility test procedures
    • Membrane filtration method
    • Direct inoculation method
  • Interpret the results of the sterility test
  • Relate failed tests to corrective action and preventive action

Endotoxin Testing

  • Define endotoxin test types
    • Gel clot test
    • Turbidimetric test
    • Chromogenic test
  • Indicate when endotoxin testing must be performed    
  • Describe the endotoxin test procedure

CSP Handling and Labeling (Non-HD & HD) 

  • Identify labeling requirements of the compounded sterile preparation
  • Describe how compounded sterile preparations must be handled
    • Storage
    • Packaging
    • Shipping and transport

Recall

  • Identify out-of-specification notification and recall requirements
    • Standard operating procedure detailing
    • Product and ingredient recall and quarantine
    • Prescriber notification

API Risk Management (HD)

  • Describe types of exposure to hazardous drugs
  • Identify potential opportunities of exposure during compounding-related activities
  • Interpret a safety data sheet
  • Classify the risk associated with an active pharmaceutical ingredient

Containment-Engineering Controls (HD)

  • Detail primary and secondary engineering controls of hazardous drug compounding
  • Describe strategies for hazardous drug compounding while working in C-SCAs, C-PECs and C-SECs.
  • Describe the use of supplemental engineering controls
    • Closed system transfer devices

Deactivating and Decontaminating (HD)

  • Discuss deactivating and decontaminating agent selection
  • Identify deactivating and decontaminating procedure frequencies
  • Explain best practice deactivating and decontaminating procedures
    • Primary engineering controls
    • Secondary engineering controls 
    • Equipment and devices