FAQ inspection procedure

Why is my facility being inspected?

In addition to the Austrian Medicines Act (AMG), the Austrian Ordinance on Good Manufacturing Practices 2009 (AMBO 2009) forms the regulatory basis for inspections in the pharmaceutical sector. Your facility falls under the scope of the AMBO 2009 if medicinal products are manufactured, controlled or placed on the market. For details as well as exemptions, please refer to § 1 AMBO 2009 or § 62 AMG. Depending on the scope of activity, which includes the facility to be inspected, the requirements of Good Manufacturing Practice or Good Distribution Practice must be met.

The annual inspection plan is drawn up on Quality Risk Management on the scope of activities and the degree of compliance with the applicable regulatory requirements and is accredited with the Federal Ministry of Health in accordance with Section 67 (1a).

What is the content of the inspection?

The content of the inspection depends on the planned or already approved scope of activities. In order to be able to assess which regulatory requirements are applicable to your facility, please view the applicable legal bases. It is also advisable to get familiar with the guidelines of Good Manufacturing Practice (GMP) or Good Distribution Practice.

During an inspection, it is not always necessary to include all areas of the regulatory requirements; in the case of initial inspections, all the main subject areas of the applicable requirements are also checked

How long does the inspection last?

The time that the on-site inspection takes depends primary on the scope of the activity, the size of the facility and the complexity of the relevant processes and can vary from half a day to ten days. In general, inspections are carried out by one inspector. If the inspection contains complex content, or if it involves an operation that carries out manipulation steps on the open product, the inspection is carried out by a team.

What can be expected during the inspection on site?

Typically, the part of an inspection that is conducted on-site at the facility consists of the following essential parts:

  • Welcome and opening of the inspection within theframework of a meeting.
  • If applicable, a visit of the production or laboratory premises, usually following the flow of goods. Processes, procedural instructions including compliance with the same, machine logbooks etc. are checked for compliance with the specifications.
  • Coordination of the inspectors followed by a final meeting including disclosure of the observations.

What documentation is reviewed as part of the inspection?

In principle, any documentation related to product quality may be reviewed by the inspectors during the inspection. This includes, for example (list not exhaustive):

  • Any existing  authorisation(s) under medicinal product law
  • Organizational chart of the facility (incl. job descriptions and proof of qualification of key personnel)
  • Procedure instructions (incl. a list )
  • Records
  • Description of the facility / Site Master File
  • Personnel & material flow
  • Quality Risk Management
  • Qualification & validation records
  • Training system (including personnel training records)
  • Sanitation program

Non-conformities (defects) were found during the inspection. What is their classification? What has to be done to correct a defect?

The rectification of any identified defects can start immediately. Normally, all defects found during the inspection are also addressed and pre-classified during the final meeting. The classification on site is a notification, the final classification is made during the acceptance of the report before it is sent to the party hearing (§ 45 Abs 3 AVG). In order to be able to classify a defect as remedied, it is necessary to provide documented evidence in the course of the response to the initial report, which proves that actions have been taken in order to remedy the defect (e.g. photo documentation, draft documents, etc.). Letters of intent do not result in the correction of a deficiency; specific corrective and preventive actions must be taken. The submission of the action plan should be collected as a statement for the hearing of the parties.

Are there consequences if deficiencies are not corrected?

If deficiencies that have occurred in the action plan are not addressed with corrective and preventive measures or are not remedied within the agreed period, there is a threat of official  actions, as far as the withdrawal of the license followed by legal actions. In addition, information about the lack of compliance with the applicable regulatory requirements will be published.

The inspection procedure is completed. When will I be inspected again?

The inspection interval essentially depends on the respective scope of activities and the degree of compliance with the applicable regulatory requirements. Follow-up inspections are performed risk based within the maximum time frame specified in the AMG.

Therefore the inspection intervals are as followed:

  • Manufacturing and control establishments: three years max.
  • Establishments processing, storing or distributing human blood or blood components, if intended for transfusion: max. two years
  • Other establishments (distributors): max. five years

Further inquiry note