Inspections

The PSI conducts various types of inspections to ensure compliance with pharmacy and medicines legislation as well as the PSI guidance.  These inspections aim to protect patients and the wider public by ensuring safe and effective pharmacy practice.

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We inspect pharmacies to assess if they are complying with pharmacy and medicines legislation, as well as the PSI guidance. Our responsibility is to maintain high standards in pharmacies, ensuring public health, safety and confidence in pharmacy care and services. 

Role of our Authorised Officers

Our Authorised Officers, who are also referred to as Quality Assessors, have the authority to conduct inspections and investigations of pharmacies. During an inspection, Quality Assessors have the right to: 

  • Enter a pharmacy premises 
  • Search the premises 
  • Take samples and seize evidence 
  • Inspect and take copies of books and records 

Our Quality Assessors are committed to upholding a strict Code of Practice. Their identities can be verified by requesting their PSI Identity Card and Authorised Officer Warrant. 

Types of Inspections

As part of the registration process with the PSI, we conduct a notified inspection for new pharmacy openings, changes in ownership, relocations and applications for continued registration. For comprehensive details on the application process and requirements for first-time registration, we invite you to click here and explore further. 

Following the inspection, our Quality Assessors will provide a comprehensive report detailing the standards and requirements, along with any areas requiring attention and a timeline for their resolution.  

Preparing for a new pharmacy opening inspection

During routine inspections, our Quality Assessors look for evidence that the pharmacy is complying with medicines and pharmacy legislation, as well as the PSI guidelines. 

Unannounced inspection 

These inspections are not notified to the pharmacy in advance. This ensures that pharmacies consistently comply with the legislation and maintain high standards of practice, even without prior notice. 

Typically, an inspection takes approximately two hours. The presence of the superintendent or supervising pharmacist is not a prerequisite for the inspection and it will proceed even if a locum or another pharmacist is on duty. Communication regarding the inspection with the superintendent or supervising pharmacist is managed internally by the pharmacy staff on the day of the inspection.  

Actions following inspection 

After an inspection, the PSI’s Quality Assessors will provide a detailed report of the inspection findings, highlighting areas of compliance and identifying any issues that need to be addressed.  This report is issued to the superintendent pharmacist.  

Preparing for a routine inspection 

  • Continue to use the Pharmacy Assessment System. This will ensure the pharmacy is prepared for the PSI inspections, reducing the risk of non-compliance and facilitating smoother inspection processes. Keep the Action Plan booklet updated, approved and signed by the relevant individuals. 
  • Refer to our comprehensive Checklist for Routine Pharmacy Inspections  
  • Watch our ‘Inspections’ Video for an introduction to what happens during an inspection. 

We also conduct themed inspections from time to time to evaluate adherence to legislative requirements concerning e.g., professional cover, the Falsified Medicines Directive, and vaccination services. 

We also carry out mystery shopper specialist surveyor exercises to assist with our risk-based approach to inspection and enforcement. 

Explore the findings from our mystery shopper exercise/specialist surveyor exercise on Domperidone and Codeine and evaluate your practice to comply with regulatory standards: 

What happens after an inspection?

Inspection Report

The inspection process is designed to help pharmacists and pharmacy owners address their practice standards and compliance with medicines and pharmacy legislation. Inspection reports are not currently published by the PSI, but each year we highlight the main findings and statistics from inspections.

Following all pharmacy inspections, a report is prepared by the PSI inspector. The report is sent to the superintendent pharmacist who is invited to provide their comments on the report.

The report outlines the observations made by the inspector at the inspection, and also includes reference to medicines and pharmacy legislation and PSI guidance. The report will also include a number of required actions or findings, which will need to be addressed in the pharmacy to ensure the pharmacy’s compliance.

Responding to an Inspection Report

The superintendent pharmacist to requested to respond to the matters outlined in the report. This response should outline the actions that have been taken to resolve the issues identified, and to ensure the pharmacy’s ongoing compliance.

For routine inspections, once all matters outlined in the inspection report have been addressed appropriately and completely by the pharmacy, the inspection process is considered complete. The superintendent pharmacist will receive a letter stating that the inspection file is closed.

It is within the PSI's power to take action if necessary in response to matters of concern found during an inspection or investigation, and you can read more about the PSI's enforcement role.

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