FAQ - GMP/GDP
In addition to the Austrian Medicines Act (Arzneimittelgesetz - AMG), the Medicines Operating Regulations 2009 (Arzneimittelbetriebsordnung 2009 - AMBO 2009), which transpose the European Directive 2003/94 EC into national law, form the regulatory basis for inspections in the pharmaceutical sector. Its production site falls within the scope of AMBO 2009, insofar as medicinal products are manufactured, controlled or placed on the market. Please refer to § 1 AMBO 2009 or § 62 AMG for details and exceptions. Depending on the scope of activity, which includes the premises to be inspected, the requirements of Good Manufacturing Practice or Good Distribution Practice shall be complied with. The annual inspection plan shall be based on a risk assessment of the scope of activities and the degree of compliance with the applicable regulatory requirements and shall be agreed 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 assess which regulatory requirements apply to your permanent establishment, please take a look at the applicable legal bases. It is also advisable to familiarise yourself with the Good Manufacturing Practice (GMP) or Good Distribution Practice guide.
When conducting an inspection, it is not always necessary to include all areas of the regulatory requirements; initial inspections also include an examination of all main areas of the requirements to be applied.
The time required for the on-site inspection depends to a large extent on the scope of activities, the size of the site and the complexity of the relevant processes and can vary between half a day and ten days. In principle, inspections are carried out by an inspector. If the order involves an inspection with complex contents or if the company carries out manipulation steps on the open product, the inspection is carried out in a team.
Typically, the part of an inspection carried out on site at the site consists of the following essential parts:
- Welcoming and opening the inspection during a meeting
- If applicable, the production or laboratory premises are inspected, usually following the flow of goods. Processes, procedural instructions including compliance with them, machine logbooks, etc. are checked for compliance with the specifications.
- Discussion between the inspectors followed by a final meeting incl. announcement of the observations
In principle, any documentation related to product quality can also be inspected by the inspectors during the inspection. This includes for example (non-exhaustive list):
- any existing drug regulatory approval(s)
- organizational chart of the operating site (incl. job descriptions and proof of qualification of key personnel)
- SOPs (including a list of them)
- description of operation / Site Master File
- personnel & flow of material
- quality risk management
- qualification & validation documents
- training system (incl. personnel training certificates)
- hygiene program
The rectification of any identified defects can be started immediately. Normally, all defects occurring during the inspection are also addressed and pre-classified during the final meeting. The classification on site should be conidered as an advice, the final classification takes place during the acceptance of the report before dispatch to the party (§ 45 para 3 AVG). In order to classify a defect as remedied, it is necessary to provide documented evidence in the course of the comment on the first report which proves that measures have been taken to remedy the defect (e.g. photo documentation, drafts of documents, etc.). Declarations of intent do not lead to the elimination of a defect; specific corrective and preventive measures must be taken. The submission of the action plan should be made as a response to the hearing procedure.
If deficiencies that are part of the submitted action plan are not remedied with corrective and preventive measures or are not remedied within the agreed period, official measures up to the withdrawal of the authorisation followed by a legal complaint threaten. In addition, information on non-compliance with the applicable regulatory requirements is published.
The inspection interval depends to a large extent on the respective scope of activities and the degree of compliance with the applicable regulatory requirements. Follow-up inspections are risk-based and carried out within the respective maximum time frame specified in the Austrian Medicines Act (AMG).
This means an inspection interval for
- production and quality control: max. three years
- establishments processing, storing or distributing human blood or blood components intended for transfusion: max. two years
- other establishments (placing on the market): max. five years