Inspection Process

Remote Inspections / Distant Assessments

In light of the current travel restrictions and risk to public health posed by the COVID-19 pandemic, the HPRA initiated a process to conduct inspections remotely via distant assessment. The requirement to conduct a distant assessment will be determined on a case-by-case basis. Notifications will be sent in advance of the distant assessment in the same way as for an on-site inspection. The distant assessment process will, in general, follow a similar format to that for an on-site inspection and will commence with an opening meeting and conclude with a closing meeting via videoconference or alternative remote communication platform.

The communication platform used will be particularly important to facilitate the smooth running of the distant assessment. The sites hosting the distant assessment will be requested to propose a suitable communications platform and this will be agreed with the Inspector in advance of the distant assessment. The process will require electronic copies of documents and other information to be provided to the Inspector for review. Consideration should be given to the use of platforms which provide for live sharing of documents and videos, in addition to the use of cameras to allow for a virtual review of physical facilities, equipment and manufacturing operations, where applicable.

To avoid delays during distant assessment, companies will be requested to make certain documentation available prior to the commencement of the distant assessment. Documentation requirements will be specified in the pre-distant assessment notification. In certain circumstances, a distant assessment on its own may not be sufficient to enable a decision to be made regarding the level of compliance with GxP requirements and, as such, an on-site inspection may be performed at the earliest possible time. It is envisaged that this would generally focus on areas of the site that could not be inspected remotely and/or areas requiring further follow-up resulting from the distant assessment.

In certain circumstances, a hybrid approach may be adopted, in that a distant assessment and on-site inspection of limited duration are conducted in conjunction with each other. In these circumstances, COVID-19 protocols and associated arrangements will be discussed and agreed with the company in advance.

Companies can involve colleagues from within their wider organisation in the distant assessment but we would ask that they refrain from bringing international colleagues to the site to support the inspection.

General Inspection Process

The HPRA shall conduct a regular inspection of each site of a blood or tissue establishment \organ procurement organisations or transplantation centres, as defined in the relevant legislation. Inspections are carried out for the purpose of ensuring:

(a) establishments/organisations/centres comply with the requirements of legislation, and

(b) problems relating to compliance with those requirements are identified.

The HPRA may conduct such additional inspections at establishments/organisations/centres as it considers necessary for the purpose of ensuring compliance with the requirements of legislation.

The Inspection Process

The Inspection Process may be summarised as follows:

  • Inspection Organised
  • Inspection Carried Out
  • Deficiencies against requirements of Regulations and Good Practice Identified
  • Report written by Inspectors and sent to establishments/organisations/centres
  • Responses (corrective actions) and timeframes submitted to HPRA and Reviewed by Inspectors
  • Further Responses Required or Further Inspection Required based on Responses
  • Close out of Inspection

Organisation of Inspection

Official Notification will be sent to the Responsible Person up to 6 weeks prior to the Inspection.

The notification shall contain an outline of the Inspection and a list of the documents required for review:

This may include:

            - Organisation Chart

            - List of all personnel employed in establishments/organisations/centres

            - Job Descriptions of Key Personnel

            - Training records

            - List of SOPs

            - List of Deviations/Non-Conformances

            - List of Complaints

            - List of Recalls

            - Validation Master Plan

The Inspection

Normally, the format of the inspection is as follows:

Opening Meeting – Inspection – Closing Meeting

The HPRA advises that relevant management personnel are present at the opening and closing meetings. During the inspection itself, the responsible person, quality manager or nominated individual(s) should be present at all times.

Opening Meeting

The opening meeting shall be conducted by the Inspector(s)

It gives an opportunity to introduce the inspection team and the participants. Some background information gathering may take place at this stage. The plan for the inspection may be discussed at this stage. The opening meeting also provides an opportunity for the establishment/organisation/centre to present an overview of activities or to update on recent developments. It is also an opportunity for the participants to ask questions prior to the beginning of the inspection.

Actual Inspection

The actual inspection is about obtaining information. This may be achieved by witnessing tasks being performed, by reviewing documented procedures, by asking questions – Who? What? When? Where? By investigating issues – Why? The inspection should always be performed with open and honest exchange. 

Closing Meeting

The closing meeting shall also be conducted by the inspector. The inspector shall explain the classification of deficiencies and present the findings of the inspection during this meeting.

The deficiencies are classified into the following categories: 

Critical deficiency

A critical deficiency may be defined as a failure which indicates a significant risk that blood/blood components, tissues/cells or organs could or would be harmful to the patient, or a failure which has produced harmful blood/blood components, tissues/cells or organs for transplantation. 

Major deficiency

A major deficiency may be defined as a non-critical failure which could or would result in blood/blood components, tissues/cells or organs obtained for transplantation that do not comply with the requirements of relevant legislation. 

Other deficiency

An ‘other’ deficiency may be defined as a failure which cannot be classified as either critical or major, but which indicates a departure from GP. These deficiencies are considered as minor. 

Points for clarification / Points to note

The observations might lead to suggestions on how to improve quality or reduce the potential for a non-compliance to occur in the future.

Participants will have an opportunity to provide further information in relation to the findings if required. The inspector(s) shall then inform participants of the next steps in the process i.e. responses required, further inspections etc.

Review of responses

The inspection report should be received within 15 days of the last day of inspection. Responses (corrective actions) and timeframes are required to be received by the HPRA 35 days after the end date of the inspection. The corrective action taken and the proposed timeframes shall be reviewed by the inspector. Further information may be requested. If the responses are satisfactory the inspection shall be closed and the inspector will instruct participants regarding follow up inspections and the next steps in the process.