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

Coorective & 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 & Release

Each preparation should be stored in 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 cleanroom facility, personnel must thoroughly wash their hands with an 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 non-sterile compounded shall perform this procedure at least annually.

Non-Sterile Compounding Finished Preparation Testing

This process is designed for planned testing to 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.