Hearing the phrase «The PSI is here» can instantly spike your stress levels, whether you’re the Supervising Pharmacist running the dispensary or a locum covering a busy weekend shift.
In reality, an inspection by the Pharmaceutical Society of Ireland (PSI) shouldn’t require a last-minute scramble. If your daily systems, logs and SOPs are maintained in real time, your dispensary is ready for an inspection on any given day.
Here is a practical look at what to expect during a PSI inspection, the different types of visits you might encounter and how to stay compliant.
Who conducts the inspection?
PSI Inspections are carried out by Quality Assessors. These are authorised officers who carry a PSI Identity Card and Warrant (which you are always entitled to ask to see when they arrive).
Under Irish pharmacy legislation, Quality Assessors have broad statutory powers to:
- Enter and inspect retail pharmacy premises.
- Review and copy registers, SOPs, books and electronic records.
- Take samples or seize evidence where non-compliance is suspected.
While Quality Assessors are there to assess legal compliance, they also follow a formal Code of Practice designed to offer guidance and practical feedback.
Types of PSI inspections
The nature of an inspection often depends on your pharmacy’s current registration status or practice focus:
- Routine inspections: Periodic visits to review day-to-day operations, standard operating procedures, storage conditions and dispensary register maintenance.
- Unannounced visits: These usually take around two hours and occur without notice. Important for locums: An unannounced inspection will proceed even if the Superintendent or Supervising Pharmacist is off-site. The pharmacist on duty handles the inspection locally while internal management is notified.
- Registration and relocation inspections: Pre-announced visits conducted before opening a new pharmacy or relocating. The assessor verifies that the physical building layout, security measures and operational governance meet statutory standards before approval.
- Themed inspections: Targeted checks on specific practice areas, such as vaccination protocols, Falsified Medicines Directive (FMD) compliance or sole-trader professional cover.
- Mystery shopping exercises: Risk-based monitoring focused on non-prescription medicine sales (like OTC codeine or domperidone) to test protocol compliance in real-world scenarios.
Staying ready day-to-day
Rather than trying to audit everything right before an announced visit, incorporate these steps into regular pharmacy routines:
- Work the Pharmacy Assessment System (PAS). Treat the PAS as a regular working document rather than a quick box-ticking exercise. Make sure the Action Plan booklet is signed off and that corrective steps noted in previous audits have actually been carried out.
- Use official PSI resources. Run periodic internal checks against the PSI’s Routine Pharmacy Inspection Checklist (checking Controlled Drug registers, duty logs and fridge temperature logs) and their joint Garda security assessment template.
- Brief your whole team (Including locums). Because unannounced visits can happen anytime, make sure locums and support staff know where SOPs are kept, how to access duty logs and who to contact if an assessor walks in.
What happens after the visit?
Once the Quality Assessor finishes their inspection, the formal review process includes:
- The inspection report: A detailed report listing findings, areas of good practice, and any non-compliance issues is sent to the Superintendent Pharmacist.
- The response: The Superintendent must reply within the set timeframe with an action plan showing proof that any issues have been resolved.
- Closure: Once the PSI reviews and accepts the remedial actions, they issue an official closure letter to complete the process.
Individual routine reports aren’t published online, but the PSI does periodically share aggregated data and trends to help pharmacies review their own processes.
Summary
An inspection doesn’t need to be a crisis. By keeping SOPs updated, maintaining logs daily and using tools like the PAS, your team can handle any PSI visit with total confidence.
For official checklists and forms, you can visit the PSI Inspections Portal.