All personnel who compound or have direct oversight of compounding sterile and/or non-sterile (CSPs & CNSPs) must be initially trained and qualified by demonstrating knowledge and competency according to the requirements before being allowed to perform their job functions independently.
Designated person(s) are responsible for creating and implementing a training program that describes the required training, the frequency of training, and the process for evaluating the competency of personnel. This program must equip personnel with knowledge and training in the required skills necessary to perform their assigned tasks. Personnel who compound or have direct oversight of compounding personnel must complete training initially and at least every 12 months at least the following:
For Sterile Products Compounding
- Hand hygiene
- Garbing
- Cleaning and disinfection
- Calculations, measuring, and mixing
- Aseptic technique
- Achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile components)
- Use of equipment
- Documentation of the compounding process (e.g., master formulation and compounding records)
- Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area
- Proper use of PECs
- Principles of movement of materials and personnel within the compounding area
For Non-Sterile Products Compounding
- Hand hygiene
- Garbing
- Cleaning and sanitizing
- Handling and transporting components and CNSPs
- Measuring and mixing
- Proper use of equipment and devices selected to compound CNSPs
- Documentation of the compounding process
Read also:
- Metrology in Pharmacy
- Master Formulation and Compounding Records
- Documentation for Compounded Nonsterile and Sterile Preparations
- Medications Considered Safe to Use during Breast Feeding
References:
- USP 〈795〉 PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS
- USP 〈797〉 PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS
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