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This document provides guidelines and procedures for conducting a GAP analysis in a compounding pharmacy to ensure compliance with USP Chapter standards for nonsterile preparations.
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How to fill out The GAP Analysis for Nonsterile Compounding
01
Identify the scope of the nonsterile compounding practices to be analyzed.
02
Gather existing policies and procedures related to nonsterile compounding.
03
Evaluate current compliance with regulatory standards and best practices.
04
Identify gaps between current practices and required standards.
05
Document findings clearly, noting specific areas where improvements are necessary.
06
Develop an action plan to address identified gaps, including timelines and responsible parties.
07
Review and update the GAP analysis regularly to ensure ongoing compliance.
Who needs The GAP Analysis for Nonsterile Compounding?
01
Pharmacies that perform nonsterile compounding.
02
Compounding pharmacists and technicians.
03
Quality assurance teams.
04
Regulatory compliance officers.
05
Healthcare organizations to ensure patient safety and care standards.
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People Also Ask about
What is a nonsterile compounding?
A. Non-sterile compounding is defined as the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation (adapted from USP <795>).
What pharmacy resource states requirements for compounding of non-sterile products?
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations.
What PPE is required for non-sterile compounding?
For compounding non-hazardous products, compounding personnel must wear powder-free gloves (nitrile or neoprene gloves are preferred) and either a disposable gown (preferred) or a clean lab coat. If needed, compounding personnel should also wear a mask, head/hair covers, and eye protection.
What are the requirements for a non-sterile compounding room?
Proper temperature and humidity control within the compounding area or facility is desirable. Work areas should be well lighted, and work sur- faces should be level and clean. The work surface should be smooth, impervious, free of cracks and crevices (preferably seamless), and nonshedding.
What is non-sterile compounding?
Non-sterile compounding are medications made in a clean environment that's not completely free from all microorganisms. This type of compounding is for drugs to be taken orally or topically.
What does CNSP stand for in pharmacy?
compounding quality nonsterile preparations. — CNSP = Compounded Non-Sterile Preparation.
Which USP chapter concerns nonsterile compounding?
USP General Chapter <795> provides standards for compounding quality nonsterile preparations.
What are the minimum requirements in compounding non-sterile preparations?
The overall areas for non-sterile compounding should be kept clean. All components, equipment and containers must be stored off the floor (i.e. the scale must not be stored on the floor). Requirements include a separate compounding area. The area must be a designated area dedicated only to non-sterile compounding.
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What is The GAP Analysis for Nonsterile Compounding?
The GAP Analysis for Nonsterile Compounding is a systematic evaluation tool used to identify and assess the differences between current practices and the required standards for nonsterile compounding to ensure compliance with regulations and safety protocols.
Who is required to file The GAP Analysis for Nonsterile Compounding?
Pharmacies and compounding facilities that engage in nonsterile compounding are required to file The GAP Analysis to demonstrate their adherence to established standards and regulations.
How to fill out The GAP Analysis for Nonsterile Compounding?
To fill out The GAP Analysis for Nonsterile Compounding, practitioners should gather relevant documentation, assess current practices against benchmark standards, complete the provided template by identifying gaps, and propose corrective actions.
What is the purpose of The GAP Analysis for Nonsterile Compounding?
The purpose of The GAP Analysis for Nonsterile Compounding is to ensure that compounding facilities meet necessary compliance requirements, improve safety, and enhance the quality of compounded medications by identifying areas for improvement.
What information must be reported on The GAP Analysis for Nonsterile Compounding?
The GAP Analysis must report information such as current practices, identified gaps against standards, compliance issues, proposed improvements, and any actions taken to address deficiencies in nonsterile compounding practices.
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