Documentation for Compounded Nonsterile and Sterile Preparations

All facilities where compounded nonsterile preparations (CNSPs) are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements. This documentation must include, but is not limited to, the following:

• Personnel training, competency assessments, and qualification records including corrective actions for any failures
• Equipment records (e.g., calibration, verification, and maintenance reports)
• COAs and all documentation required for components not conventionally manufactured
• Receipt of components
• SOPs, MFRs (Master Formulations), and CRs (Compounding Records)
• Release inspection and testing records
• Information related to complaints and adverse events including corrective actions taken
• Results of investigations and corrective actions
• Records of cleaning and sanitizing the designated compounding area
• Temperature logs
• Accommodations to personnel compounding CNSPs
• Any required routine review (e.g., yearly review of QA and QC programs, yearly review of chemical hazard and disposal information)

All facilities where compounded sterile preparations (CSPs) are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements. This documentation must include, but is not limited to, the following:

• Personnel training, competency assessments, and qualification records including corrective actions for any failures
• Certification reports, including corrective actions for any failures
• Environmental air and surface monitoring procedures and results
• Equipment records (e.g., calibration, verification, and maintenance reports)
• Receipt of components
• SOPs, MFRs (if required), and CRs (if required)
• Release inspection and testing records
• Information related to complaints and adverse events including corrective actions taken
• Results of investigations and corrective actions

Documentation must comply with all laws and regulations of the applicable regulatory jurisdiction. Records must be legible and stored in a manner that prevents their deterioration and/or loss. All required CRs for a particular CNSP (e.g., MFR, CR, and release inspection and testing results) must be readily retrievable for at least 2 years after preparation or as required by the laws and regulations of the applicable regulatory jurisdiction, whichever is longer.

Read also:

• Metrology in Pharmacy
  
• Master Formulation and Compounding Records
• Knowledge and Competency Core Skill for Compounding
• Common Abbreviations Used in Pharmacy
  

References:

• USP 〈795〉 PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS
• USP 〈797〉 PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS