A master formulation record (MFR) is a detailed record of procedures that describes how the CNSP or CSP is to be prepared. An MFR must be created for each unique formulation of a CNSP or CSP. CNSPs or CSPs are to be prepared according to the MFR, and the details of each preparation are to be documented on a compounding record. Any changes or alterations to the MFR must be approved and documented according to the facility’s SOP.
An MFR must include at least the following information:
- Name, strength or activity, and dosage form
- Identities and amounts of all ingredients; if applicable, relevant characteristics of components (e.g., particle size, salt form, purity grade, solubility)
- Type and size of container closure system(s)
- Complete instructions for preparing the CSP or CNSP, including equipment, supplies, a description of the compounding steps, and any special precautions
- Physical description of the final CSP or CNSP
- Beyond-use date (BUD) and storage requirements
- Reference source to support the assigned BUD or stability of the CSP or CNSP
- If applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s) for CSPs or CNSPs
- Labeling requirements (e.g., shake well)
- Quality control (QC) procedures (e.g., pH testing, filter integrity testing)
- Other information as needed to describe the compounding process and ensure repeatability (e.g., adjusting pH and tonicity; sterilization method, such as steam, dry heat, irradiation, or filter)
A compounding record (CR) documents the compounding of each CNSP or CSP. A CR must be created for all CNSPs or CSPs. Each CR must be reviewed for completeness before the CNSP or CSP is released. The name or other unique identifier of the person completing the review and the date of the review must be documented on the CR. The CR must permit traceability of all components in the case of a recall or known quality issue.
A CR must include at least the following information:
- Name, strength or activity, and dosage form
- Date and time of preparation
- Assigned internal identification number (e.g., prescription, order, or lot number)
- A method to identify the individuals involved in the compounding process and individuals verifying the final CNSP or CSP
- Name, vendor or manufacturer, lot number, and expiration date of each component
- Weight or measurement of each component
- Total quantity of the CNSP or CSP compounded
- Assigned beyond-use date (BUD) and storage requirements
- If applicable, calculations to determine and verify quantities and/or concentrations of components and strength or activity of the API(s)
- Physical description of the final CNSP or CSP
- Results of quality control procedures (e.g., pH testing and visual inspection)
- MFR reference for the CNSP or CSP
Read also:
- Metrology in Pharmacy
- Knowledge and Competency Core Skill for Compounding
- Documentation for Compounded Nonsterile and Sterile Preparations
References:
- USP 〈795〉 PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS
- USP 〈797〉 PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS
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