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Pharmacy Compounding Safety Audit Checklist

A comprehensive checklist for auditing compounding safety practices in pharmacies, covering sterile and non-sterile procedures, equipment maintenance, and personnel training to ensure product quality and patient safety.

Pharmacy Compounding Safety Audit Checklist

by: audit-now
4.1

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About This Checklist

Pharmacy compounding is a critical service that requires strict adherence to safety protocols and quality standards. This Pharmacy Compounding Safety Audit Checklist is designed to help healthcare professionals systematically evaluate and improve compounding practices. By addressing key areas such as sterile and non-sterile compounding procedures, equipment maintenance, and personnel training, this checklist helps identify potential risks, ensure regulatory compliance, and maintain the highest standards of patient safety. Regular use of this checklist can significantly reduce the risk of contamination, improve product quality, and ultimately contribute to better patient outcomes in specialized medication needs.

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Industry

Healthcare

Standard

USP Compounding Standards

Workspaces

Pharmacies

Occupations

Compounding Pharmacists
Pharmacy Technicians
Quality Assurance Specialists
Sterile Compounding Supervisors
Pharmacy Managers
1
Is the aseptic technique being followed correctly during compounding?
2
Is there an active environmental monitoring program in place?
3
What is the total number of training hours provided to personnel on compounding safety?
Min: 0
Target: 20
Max: 100
4
Is the compounding equipment regularly maintained?
5
Are regular quality assurance checks being conducted on compounded products?
6
Please provide details of any incidents related to compounding safety in the last month.
7
Rate the cleanliness of the compounding area.

1

2

3

4

5

8
What was the date of the last training session on compounding safety?
9
Are procedures for handling hazardous materials being followed correctly?
10
What emergency equipment is available in the compounding area?
11
How often is the compounding equipment calibrated (in months)?
Min: 1
Target: 6
Max: 12
12
When was the last safety audit conducted in the compounding area?

FAQs

The audit should be conducted at least quarterly, with more frequent checks for high-risk compounding areas or as required by state regulations.

The audit is typically performed by specially trained pharmacists, compounding specialists, or quality assurance personnel with expertise in compounding practices.

The checklist covers areas such as environmental monitoring, equipment calibration, aseptic technique, documentation practices, and personnel training and competency.

Audit results can be used to identify areas for improvement, update standard operating procedures, enhance staff training programs, and implement corrective actions to ensure compliance and safety.

Yes, the checklist is designed to be adaptable for various pharmacy settings that offer compounding services, including hospital, community, and specialty pharmacies, with adjustments based on the specific type and scale of compounding performed.

Benefits of Pharmacy Compounding Safety Audit Checklist

Ensures compliance with USP <797> and <795> standards for sterile and non-sterile compounding

Reduces the risk of contamination and medication errors in compounded products

Improves the quality and consistency of compounded medications

Enhances staff competency and adherence to proper compounding techniques

Facilitates continuous improvement in compounding practices and workflows