Inspection of the manufacture of medicinal products

The main task of the inspector is to protect public and animal health. This is done by ensuring that manufacturers comply both with cGMP and with the marketing authorisation for the manufactured medicinal products. The inspector must determine whether the different elements of the quality system are effective and comply with cGMP.

Inspection is one of several tools to ensure the quality of a medicinal product. The inspection provides a snapshot of the operation, which in itself must provide sufficient information to enable the inspector to assess the safety and compliance with the guidelines and requirements in the manufacture of medicinal products.

Risk-based planning

Inspection of a manufacturer takes place regularly, every 2 to 3 years. The planning of inspections is risk-based and certain types of manufacturing will thus be inspected more frequently, such as sterile manufacturing.

In the case of a new application for a manufacturing authorisation, the Swedish Medical Products Agency (Swedish MPA) will always inspect the activity and based upon assessment of risk the first inspection thereafter often takes place within a shorter interval than 2 years.

Inspections may also be planned more frequently if there are reasons for doing so such as in the event of major changes in the manufacturer’s activities.

Unannounced inspections

The Swedish MPA often contacts the manufacturer to book the inspection, but an inspection may also be unannounced. An inspector from the Swedish MPA always carries an ID card to identify him- or herself.

You must admit the Swedish MPA and may not refuse inspection

You must provide the information and documents requested and necessary for supervision. The Swedish MPA has the right of access to areas, premises and other spaces used in connection with manufacturing. This includes the right for the  authority to take photographs at the facility.

This is stipulated in Chapter 14, Article 2 of the Medicinal Products Act (2015:315) (in Swedish).