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 

Regulatory Framework and Standards of Practice

• Discuss the Drug Quality and Security Act
• Compare the Traditional Compounder (503A) to the Outsourcing Facility (503B)
• Outline the Food and Drug Administration’s role in sterile compounding
• Describe the United States Pharmacopeia General Chapters applicable to sterile compounding
• Differentiate Federal and State jurisdictional authority in regulating sterile compounding
• Identify key matters of noncompliance as documented in FDA Form 483 inspection reports
• Explain the corrective action and preventive action plan in response to an FDA inspection

Roles and Responsibilities (Non-HD & HD)

• Identify roles and responsibilities of compounding facility personnel
  • Designated person
  • Compounding personnel with direct oversight
  • Compounding personnel
  • Restocking, cleaning, and disinfecting personnel
  • Assigned trainer

Standard Operating Procedures

• List required and best practice standard operating procedures
• Discuss the subsections of a standard operating procedure
• Apply a classification system to standard operating procedures

Documentation

• Classify document types by qualification, quality assurance and quality control activities
• Apply good documentation practice principles to…
  • Standard operating procedures
  • Personnel training logs and competency assessments
  • Personnel ongoing compliance assessments
  • Environmental management and monitoring
  • Equipment, supplies, and components
  • Master Formulation/Compounding Records
  • Quality controlled product release documents

Competency Requirements (Non-HD & HD)

• Identify training and competency assessment skill sets
  • Theoretical
  • Practical
• Develop a structured training and competency assessment plan
• Relate daily performance data to ongoing compliance assessments

Personal Hygiene and Behavior

• Learn strategies essential to maintaining microbial control of the classified environment
• Identify high risk personal circumstances or conditions that impact the classified environment

Garbing and Hand Hygiene Competency Evaluation

• Discuss the Garbing and Hand Hygiene Competency Evaluation
• Perform proper hand hygiene techniques
  • Hand washing procedures
  • Hand sanitizing procedures
• Summarize donning and doffing techniques of non-hazardous sterile compounding
• Describe personal protective equipment requirements of…
  • Immediate-use compounding
  • Preparing Category 1 Compounded Sterile Preparations
  • Preparing Category 2 Compounded Sterile Preparations
  • Preparing Category 3 Compounded Sterile Preparations

Aseptic Manipulation Competency Evaluation

• Discuss the Aseptic Manipulation Competency Evaluation
• Discuss procedure-related design strategies of the Aseptic Manipulation Competency Evaluation

Segregated Compounding Area

• Describe design features of the segregated compounding area
• Identify requirements of the segregated compounding area

Primary Engineering Controls

• Describe pre-sterilization containment primary engineering controls
• Describe functional principles of the ISO Class 5 primary engineering control
  • Laminar Airflow Systems
  • Restricted-Access Barrier Systems
  • Pharmaceutical Isolators
• Describe principles of high-efficiency particulate air-filtered unidirectional airflow within the ISO Class 5 environment

Secondary Engineering Controls

• Describe structural, functional, and operational parameters
  • Anteroom
  • Pre-sterilization room (optional)
  • Buffer room
• Determine relative position and function of engineering controls
  • Fan filter units
  • Intake grilles and plenums
  • Primary engineering controls
  • Doors
  • Pass-through
• Determine relative position of equipment to engineering controls
  • Sinks
  • Storage units
• Summarize primary and secondary engineering control operational parameters relative to each other
  • Air changes per hour (ACPH)
  • Dynamic airflow patterns
• Discuss common errors in cleanroom design
• Relate air quality-related operational parameters to potential challenges and verification methods

Certification

• Interpret certification reports
• Summarize certification test types
  • Airflow
  • HEPA Filter integrity
  • Total particle count
  • Dynamic airflow smoke pattern
  • Site installation assessment (CAI and CACI)
  • Chamber pressure (CAI and CACI)
  • Preparation ingress and egress (CAI and CACI)
  • Particle containment integrity and enclosure leak (CACI only)

Equipment, Supplies and Components

• Select equipment and supplies based on performance parameters
• Relate analytical parameters to electromechanical equipment function
  • Efficacy
  • Reliability
  • Validity
• Discuss equipment calibration and verification
• Perform accuracy and precision verifications of automated compounding devices

Waste Management (Non-HD & HD)

• Detail the waste management cycle of a sterile compounding facility
• Identify Environmental Protection Agency color codes used for waste management receptacles
• Explain waste management program requirements of non-hazardous and hazardous drug compounding
• Summarize disposal strategies of non-hazardous and hazardous drugs

Vendor Qualification

• Identify vendors that require qualification
• Discuss vendor qualification strategies
• Identify vendor qualification requirements

Inventory Handling (Non-HD & HD)

• Identify component handling requirements
  • Receiving
  • Unpacking
  • Inspection
  • Storing
  • Shipping and transporting
• Summarize strategies for component safe handling

Spills and Contamination (Non-HD & HD)

• Recognize hazards associated with chemical spills
• Relate different types of spill kits to chemical spills
• Design procedures to manage chemical spills

Microbiological Surface Sampling

• Discuss the purpose of microbiological surface sampling
• List microbiological surface sampling requirements of Category 1, 2 and 3 Compounded Sterile Preparations
• Develop a site sampling plan
• Apply microbiological surface sampling procedures
• Identify circumstances for which sampling is required
• Identify action levels of ISO classified rooms
• Identify trends over time while results fall within acceptable levels
• Identify microbiological surface sampling recording requirements
• List possible corrective actions

Microbiological Air Sampling

• Discuss the purpose of viable impact volumetric airborne particulate sampling
• List microbiological air sampling requirements of Category 1, 2 and 3 Compounded Sterile Preparations
• Develop a site sampling plan
• Apply microbiological air sampling procedures  
• Identify circumstances for which sampling is required
• Identify action levels of ISO classified rooms
• Identify trends over time while results fall within acceptable levels
• Identify microbiological air sampling recording requirements
• List possible corrective action measures

Formulation Ingredients

• Identify characteristics of active pharmaceutical ingredients and excipients that affect formulation integrity
• Group active pharmaceutical ingredients by classification and management considerations
• Recognize high-alert medications in the acute care setting
• Discuss excipient function in sterile formulations

Electrolytes, mmol, mEq and Gram Conversions

• Perform electrolyte, mmol, mEq and gram conversions

Age, Weight, and Body Surface Area

• Perform dosing adjustments based on…
  • Body weight
  • Body surface area
  • Drug-specific dosing requirements

Parenteral Delivery

• Calculate infusion amounts, rates, and duration based on the method of infusion

Total Parenteral Nutrition

• Calculate total parenteral nutrition requirements

Complaints and Adverse Events

• Identify compounding facility responsibilities surrounding complaints and adverse events
  • Standard operating procedure detailing
  • Designated person investigation
  • Corrective action
  • Documentation
• Identify adverse event reporting requirements              

Hazard Communication Program (HD)

• Explain the purpose of a hazard communication program
• List the responsibilities of personnel in hazardous drug management
• List personnel training requirements of hazardous drug compounding
• Describe the components of a hazard communication program
• Identify standard operating procedure requirements of hazardous drug compounding

Medical Surveillance (HD)

• Recognize appropriate preventive strategies related to hazardous drug compounding
• Recognize appropriate responses to known or suspected hazardous drug exposure
• Detail an action plan for an initial and ongoing medical surveillance strategy

Personal Protective Equipment (HD)

• Describe personal protective equipment requirements of hazardous drug handling and compounding

Environmental Wipe Sampling (HD)

• Discuss the purpose of environmental wipe sampling
• List environmental wipe sampling requirements  
• Develop a site sampling plan
• Establish the frequency with which environmental wipe sampling is required
• List possible corrective actions

Allergenic Extracts

• Define allergenic extracts
• List personnel qualifications
  • Designated person
  • Compounding personnel
• Outline facility requirements
• Outline cleaning and disinfecting procedures
• Establish beyond-use dates
• Describe labeling requirements
• Outline shipping and transportation requirements
• List documentation requirements
• List compounding record requirements