Inspections and inspectors: the complaint process

Manufacturers of medicines and biologicals are regularly inspected by the TGA using a risk-based approach to ensure compliance with manufacturing principles.

The TGA aims to resolve complaints informally wherever possible. However, more serious concerns should be made in writing to the Branch Head of the Manufacturing Quality Branch at the TGA.

The TGA recognises that the effective management of complaints and disputes contributes to improvements in regulatory services.

Process

The complaint process is explained in the opening and closing meetings of an inspection. All complaints that are received are recorded in the TGA inspection quality system and marked with the necessary level of confidentiality. Details of the investigation, as well any recommendations to be made, will be recorded.

The following steps are taken for written complaints:

1. An independent investigator is assigned by the Branch Head of the Manufacturing Quality Branch or the Quality System Manager. The investigator may review any record, interview staff and/or contact the complainant.
2. The Branch Head of Manufacturing Quality Branch or Quality System Manager (or person nominated by them) will advise the complainant of the outcome in writing.
3. The progress of complaints received and corrective actions required will be reviewed by the Quality System Manager and recorded each month.

Complaints against TGA staff involved in inspections

All complaints concerning the behaviour of staff are to be referred to the Branch Head of the Manufacturing Quality Branch at the TGA.

The Branch Head will establish how the complaint should be handled by determining whether the complaint is about:

• a suspected breach of the APS Code of Conduct
  • Complaints involving a suspected breach of the Code of Conduct by an APS employee are to be investigated using the 'Department of Health's procedure for guidance on investigation and determination' (see also s15 Public Service Act 1999), including any actions to be taken and records to be maintained.
• behaviour that is inconsistent with the attributes expected of an inspector
• the application of a TGA policy, or interpretation of a Code of GMP, QMS Standard or regulatory requirement.

Details of complaints against staff will be de-identified in the tracking system to ensure compliance with the Privacy Act 1988.

Disputes regarding an observation or finding arising from an inspection

The TGA aims to minimise misunderstandings and resolve any disputes regarding observations or findings arising from an inspection in a timely manner and in the most direct way possible.

Inspections are designed to allow for open communication with ample opportunity to raise any concerns with the Lead Inspector.

1. The dispute handling process is explained in the opening and closing meetings.
2. All disputes received are logged, monitored and recorded by the TGA.
3. At the closing meeting the Lead Inspector will present the manufacturer with a written Closing meeting summary. The Lead Inspector will explain the findings and observations, and the manufacturer will have an opportunity to raise any concerns.
4. Any matters arising from the inspection can be discussed with the Lead Inspector at any time prior to the issuing of the inspection report (usually no more than 4 weeks after the closing meeting).
5. If the dispute cannot be resolved with the Lead Inspector, the dispute may be referred to an inspection manager.
6. Once the inspection report has been issued, the point(s) of dispute need to be provided to the TGA in writing. The relevant inspection team manager will consider the dispute, and if necessary, the dispute will be directed to the Branch Head of the Manufacturing Quality Branch.