Single logo

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

Get Template

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.

Learn more

Industry

Healthcare

Standard

USP <797> and <795> Guidelines

Workspaces

Pharmacies

Occupations

Compounding Pharmacists
Pharmacy Technicians
Quality Assurance Specialists
Sterile Compounding Supervisors
Pharmacy Managers

Compounding Safety Practices

(0 / 4)

1
Is the compounding equipment regularly maintained?

Select equipment maintenance status.

To ensure that all compounding equipment is functioning properly and safely.
2
What is the total number of training hours provided to personnel on compounding safety?

Enter the total training hours.

To assess whether personnel are adequately trained in compounding safety practices.
Min: 0
Target: 20
Max: 100
3
Is there an active environmental monitoring program in place?

Indicate if an environmental monitoring program exists.

To verify that the compounding environment is consistently monitored for contamination.
4
Is the aseptic technique being followed correctly during compounding?

Select compliance status.

To ensure that sterile compounding is performed in a manner that prevents contamination.
5
What was the date of the last training session on compounding safety?

Enter the last training date.

To track the frequency of training sessions for personnel involved in compounding.
6
Rate the cleanliness of the compounding area.

Rate from 1 (Very Poor) to 5 (Excellent).

To evaluate the hygiene and cleanliness standards in the compounding area.

1

2

3

4

5

7
Please provide details of any incidents related to compounding safety in the last month.

Describe any incidents or issues.

To document and review any safety incidents that may affect compounding practices.
8
Are regular quality assurance checks being conducted on compounded products?

Select the quality assurance status.

To ensure that compounded products meet the required quality standards.
9
When was the last safety audit conducted in the compounding area?

Enter the date of the last safety audit.

To track the frequency of safety audits and ensure compliance with safety standards.
10
How often is the compounding equipment calibrated (in months)?

Enter the calibration frequency in months.

To ensure that compounding equipment is regularly calibrated for accuracy.
Min: 1
Target: 6
Max: 12
11
What emergency equipment is available in the compounding area?

List available emergency equipment.

To verify that appropriate emergency equipment is accessible in case of incidents.
12
Are procedures for handling hazardous materials being followed correctly?

Select compliance status for hazardous material handling.

To ensure safety protocols for hazardous material handling are effectively implemented.

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

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