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:
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Good Documentation Practices - All staff are required to permanently record all data accurately and promptly.
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Corrective and Preventative Action Management - All staff are able to identify and correct a nonconformity in procedures and document any changes in processes.
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Formula Worksheet - Compounding worksheets should be completed before being dispensed to a patient. The medication should have patient details and medication details listed.
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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.
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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"
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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.
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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.
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Required GARB for Non-sterile compounding area - Compounding personnel must be properly gowned to protect product integrity.
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Non-Sterile Compounding Process Validation - Each no -sterile compounder shall perform this procedure at least annually.
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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.
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Safety Procedures - All staff are familiar with safety procedures and aware of hazardous materials.