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 Compounding Sterile Preparations. It outlines the responsibilities of compounding personnel, risk levels for microbial contamination, and various standard operating procedures (SOPs) necessary for ensuring the safety and efficacy of compounded sterile preparations. The survey includes detailed requirements for training, environmental controls, quality assurance, and patient monitoring related to sterile compounding practices.
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  1. Click ‘Get Form’ to open the GAP ANALYSIS SURVEY in our editor.
  2. Begin with the 'Introduction' section. Answer each question regarding your pharmacy's compliance with USP Chapter <797> by selecting 'YES' or 'NO' and providing comments where necessary.
  3. Move to the 'Requirements' section. Here, ensure that all personnel involved in compounding CSPs are documented as having received formal training. Fill in the required fields accurately.
  4. Continue through each section, including definitions, responsibilities of compounding personnel, and risk levels. For each item, indicate compliance status and add comments for clarity.
  5. Once all sections are completed, review your entries for accuracy. Use our platform’s editing tools to make any necessary adjustments before finalizing.

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

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

Compounding Sterile Preparations Pdf

Sterile compounding involves mixing, diluting, or reconstituting drugs under strict aseptic conditions within a controlled environment such as a laminar airflow

Learn more
YAFI 1SEP2023 IMMEDICATE USE MEDICATIONS draft

Sep 1, 2023 These guidelines affect not only sterile medications compounded in pharmacy clean rooms, but also injectable medications that may be compounded

Learn more
FINAL REPORT

May 5, 2017 Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply

Learn more

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