Inspections relating to controlled drugs

We inspect operators of controlled drugs. We make sure that they comply with the requirements of the Misuse of Drugs Legal Framework. We may perform an inspection as part of the application process for a new licence or registration.

A risk-based approach to planning

We plan our inspections based on the compliance risk. This is the level of compliance observed in previous inspections. We also plan our inspections on the intrinsic risk. This is how complex the operations are at the site. We also consider what schedule, or category, the controlled drug or precursor chemical is in.

For example, an operation with a controlled drug in schedule 2 would have a higher risk than an operation with a controlled drug in schedule 5.

We perform two types of inspections:

  • Routine inspection
  • Non-routine (for cause) inspection

Frequency of inspection

How often we perform an inspection will depend on the activities at the site and the findings of previous inspections.

The process for routine inspections

Notification
Normally, the company will be notified via email six weeks before the proposed inspection date.

The notification will include:

  • A list of the inspectors.
  • The duration of the inspection.
  • A list of documents to be prepared in advance of the inspection.
Inspection
The inspection will be performed by the HPRA Inspection Team. The duration of the inspection and how many inspectors will be present can vary. This depends on the risk that is related to the operation.

The HPRA Inspection Team will focus on:

  • The quality management system that is in place at the site.
  • A review of the storage areas at the site.
  • A review of the equipment validation (if it needs to be validated).
The team will review records to check whether the operation is compliant. They will also interview staff that work in controlled drugs or precursor chemicals at the site.
Issuance of a report
An inspection report is issued following any type of inspection. The deficiencies of the inspection will be classified into three categories: 'Critical', 'Major', and 'Other'.
Response to report and close out
The site must prepare a response to each individual deficiency and point for clarification outlined in the inspection report. The response must include any proposed/completed corrective action(s) and date(s) for completion of the corrective action(s).

It is expected that critical or major deficiencies are addressed immediately.

Further correspondence may occur until the HPRA Inspection Team concludes that the site responses are satisfactory.

If all of the proposed actions are accepted, the controlled drug or precursor chemical licence will be issued.