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GAP ANALYSIS SURVEY COMPOUNDING STERILE PREPARATIONS

GAP ANALYSIS SURVEY COMPOUNDING STERILE PREPARATIONS 2025

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The document is a comprehensive survey designed to assess compliance with USP Chapter <797> regarding Pharmaceutical Compounding-Sterile Preparations. It outlines various requirements and best practices for compounding sterile preparations, including personnel training, environmental controls, risk levels, quality assurance, and patient monitoring. The survey serves as a tool for pharmacies to evaluate their adherence to standards aimed at ensuring the safety and efficacy of compounded sterile products.

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What is a gap analysis in pharma?

Medical Affairs Professional Society (MAPS) | 2023. Gap Analyses: A Strategic Planning Tool. Systematic process of comparison. Identifies deficiencies, needs, or improvements that may be required to. reach a goal for a product in a specific therapy area.

How many risk levels when it comes to compounding sterile preparations?

As outlined in the table below, the revised chapter changed the categorization of compounded sterile preparations (CSPs) from microbial contamination risk levels (i.e., low-, medium-, and high-risk levels) to Category 1 and Category 2 CSPs.

What are the USP chapter 797 procedures that must be performed when compounding pediatric medications?

Regular staff training for USP Antiseptic hand washing procedures and personnel preparation. Use of appropriate protective garb, such as gloves, gowns, and masks. How to clean, disinfect, and maintain the compounding environment. Calculations and measurement of ingredients.

What are examples of compounded sterile preparations?

We can compound sterile ophthalmic drops, ointments, sprays, injections and pre-op solutions, including anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, ophthalmic decongestants, miotics, mydriatics, and lubricants.

What is gap analysis in pharmacy?

Gap analysis is a crucial process for identifying areas of discrepancies in clinical research processes or documents and ensuring compliance with regulatory requirements.

What is a sterile compounding of products?

In sterile compounding, drug formulations are prepared in a clean-room environment using aseptic techniques to ensure preparations are free of microorganisms.

What is the gap in pharmacology?

Clinical pharmacology gap analysis is a tool for outlining your drug programs needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs.

What is a gap analysis in medicine?

A gap analysis in healthcare is intended to identify gaps in services or processesinstances in which what is happening is falling short of what should be happeningand shine a light on why these gaps exist. Such an analysis is crucial for improving care delivery and outcomes.

What is the purpose of a gap analysis?

A gap analysis is a method of assessing the performance of a business unit to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them.

GAP ANALYSIS SURVEY COMPOUNDING STERILE PREPARATIONS 2025

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