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).

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

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.

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.

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

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.

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 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

Pursuant to Section 67 para. 1 AMG , the Federal Office for Safety in Health Care shall periodically review establishments pursuant to Section 62 para. 1 leg. cit. before granting a licence pursuant to § 63 para. 1 or, if necessary, before granting a licence pursuant to § 65 para. 1 and subsequently periodically on the basis of a risk assessment to check whether the provisions of this section or the ordinances issued on the basis of this section are complied with and whether the quality of the medicinal products or active substances required for health and life is guaranteed.

This leads to the expectation of the BASG that an establishment authorised under medicinal product law is ready for inspection at all times, provided that the authorisation pursuant to Sections 63 AMG, 63a AMG or 30 TAMG is used, i.e. active substances or medicinal products are manufactured, controlled or placed on the market at the site. In this case, key personnel or their deputies are also available to support the inspection.

It is therefore not possible to postpone an announced inspection date due to internal processes or the absence of key personnel at the establishment, provided the establishment licence is in use at the time the inspection is carried out.

If the establishment is closed for activities relevant to medicinal products legislation on the announced inspection date (e.g. company holidays), no on-site inspection will take place. The BASG must be informed of this in good time so that a new date can be arranged promptly.

At the request of the company, inspections can also be brought forward if the BASG's resources permit. The BASG must be informed of this in good time.