©2019 by McKenzies Compounding Chemist

Quality Assurance 

Every compounding pharmacy should have a well maintained record collection for quality assurance. Here is a list we follow to keep our compounding pharmacy standards:

  • Good Documentation Practices - All staff are required to permanently record all data accurately and promptly.

  • Corrective and Preventative Action Management - All staff are able to identify and correct a nonconformity in procedures and document any changes in processes.

  • Formula Worksheet - Compounding worksheets should be completed before being dispensed to a patient. The medication should have patient details and medication details listed.

  • Product Quarantine, Storage and Release - Each preparation should be stored in the strict accordance with the specific storage requirements of that preparation. The responsible pharmacist shall review the compounding record and medication before release. 

  • Destruction of Expired Product Requirements - All Raw and compounded materials should be checked for expiration dates at regular intervals. If an item is expired it should be placed in a box labelled "Expired, Not For Distribution"

  • Recall of Compounded Product - In the event that a compounded product is suspected or confirmed to have caused patient harm, all facilities or patients must be notified immediately with a formal recall letter to follow. A comprehensive list of lot numbers affected shall be retrieved from data devices. 

  • Proper Hand Washing Procedure - Before operation in the clean room facility, personnel must thoroughly wash their hands with antimicrobial skin cleanser to protect product integrity and sterility. 

  • Required GARB for Non-sterile compounding area - Compounding personnel must be properly gowned to protect product integrity. 

  • Non-Sterile Compounding Process Validation - Each no -sterile compounder shall perform this procedure at least annually. 

  • Non-Sterile Compounding finished preparation testing - This process is designed for planned testing top verify and demonstrate the effectiveness of procures and stability of products. 

  • Safety Procedures - All staff are familiar with safety procedures and aware of hazardous materials.