Inspections relating to scheduled substances
Operators of scheduled substances in Ireland are regularly inspected by the HPRA using a risk-based approach to ensure compliance with the relevant legislation, such as:
- Regulation (EC) No. 273/2004 (as amended), which lays down the rules governing the monitoring of intra-Community trade.
- Council Regulation (EC) No. 111/2005 (as amended), which lays down rules for the monitoring of trade between the Community and third countries in drug precursors.
An inspection is conducted as part of the assessment for a new licence or registration application.
In addition to routine inspections to determine ongoing compliance, the HPRA may perform non-routine (for cause) inspections. The frequency of inspections may increase depending on the activities of the site and the findings of previous inspections. The HPRA operates a system of risk-based inspection planning. Scheduling of inspections is dependent on compliance risk (level of compliance in the last inspection) and intrinsic risk, which is determined based on the complexity of the operations and category of scheduled substance.
Routine inspections
Routine inspections to assess compliance follow the procedure outlined below.
Notification of inspection
The HPRA will notify the company by email typically six weeks prior to the proposed inspection date. The email notification will include the name and number of inspectors, duration of the inspection and a list of documents the company should prepare in advance of the inspection.
Inspection
HPRA inspectors will perform the inspection. The duration of the inspection and the number of inspectors present on an inspection will vary depending on the complexity of the activities conducted at the site and the findings of previous inspections. The inspection will focus on the quality management system in place, review of storage areas and associated validation of equipment as applicable. A review of records is typically completed to ensure compliance of the operations. Staff assigned to the operations involving precursor chemicals will also be interviewed as part of the inspection.
Issuance of a report
Following inspection, a report is issued to the inspected site where deficiencies are classified into three categories; critical, major and other.
Inspected sites must reply to the deficiencies stating proposed /completed corrective action(s) relating to the individual deficiency and date(s) for completion of the corrective action(s). It is expected that any critical or major findings are addressed immediately.
Company response to report and close out
The company must provide a response to the deficiencies and points for clarification outlined in the inspection report. The responses are reviewed by the inspection team to determine whether or not they are acceptable. Further correspondence between the HPRA and the company may be required until satisfactory actions are agreed. The precursor chemical licence or registration will be issued if all actions proposed by the company in response to the deficiencies cited are deemed acceptable.