Pharmacy pre-opening inspection report - College of 2026

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The document is a Pharmacy Compounding Declaration that collects essential information about a pharmacy, including its contact details, staff members, and the types of compounding services it offers. It requires the pharmacy manager's signature and submission of a gap analysis checklist to a specified contact.
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  1. Click ‘Get Form’ to open the pharmacy pre-opening inspection report in the editor.
  2. Begin by entering your pharmacy information, including the name, SCPP Permit number, address, and contact details. Ensure all fields are accurately filled to avoid any delays.
  3. Next, specify your hours of operation for each day of the week. This section is crucial for compliance and operational transparency.
  4. In the Pharmacy Staff section, list all relevant personnel including the Pharmacy Manager and Compounding Supervisor along with their SCPP License numbers. Include details about pharmacists, technicians, and assistants on staff.
  5. Proceed to indicate the compounding services you will provide. Clearly mark whether you will be compounding at Level B or C and specify if you will engage in non-hazardous or hazardous sterile compounding.
  6. Finally, ensure that the Pharmacy Manager signs the declaration before submitting it along with any required checklists via email or fax as indicated.

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Its primary goal is to find and rectify defects or deviations in real time, so that only quality products are made and delivered to customers. This proactive approach enables manufacturers to maintain consistent quality, reduce waste, and improve efficiency by addressing potential issues before they escalate.
The objectives of inspection include detecting faulty raw materials or products, preventing substandard products from docHubing customers, and promoting the reputation of a companys quality. While inspection is necessary, it also has some drawbacks such as adding costs and being partially subjective.
The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization to manufacture specific pharmaceutical products, usually in relation to an application for marketing authorization.

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Inspections Help Ensure Drug Safety and Quality FDA works to ensure the medications that are available to hospitals, health systems and patients are safe, effective and of high quality. For application products, typically prescription drugs, FDAs approval process is the first step.
During an inspection visit the Inspector will examine how the pharmacy operates with the aim of ensuring that the supply of medicines and the provision of pharmacy services to patients from a registered pharmacy are safe and appropriate.

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