Regulatory compliance | Oriola

Oriola’s quality management is based on the laws and regulatory requirements applicable in the pharmaceutical sector as well as on quality management standards, especially ISO 9001 and GDP. Pharmaceutical distribution and wholesale are regulated by the Good Distribution Practice (GDP) of the European Medicines Agency (EMA). In Finland, compliance with the GDP is monitored by the Finnish Medicines Agency Fimea and in Sweden by the Medical Product Agency, MPA. GDP defines the common rules of handling pharmaceuticals. Where applicable, our operations are also guided by the Good Manufacturing Practices (GMP) and other regulation concerning products that come under regulatory control, such as food and cosmetics.

International regulations have been adopted into national legislation with the help of Fimea in Finland and its Swedish counterpart MPA. The regulatory requirements are included in Oriola’s internal guidelines, and all our personnel dealing with pharmaceuticals receive relevant training. The compliance of Oriola functions is continuously monitored and developed through inspections carried out by the authorities, pharmaceutical companies and internal quality auditors. Each year, Oriola is audited by customers and authorities up to 80 times a year.

The management systems support the needs and special characteristics of the various business areas.

 

Business Area 

Management systems based on standards / regulations

BA Pharma

ISO 9001:2015 Quality Management System (Multisite)

ISO 14001:2015 Environment Management System (Sweden)

GDP, GMP

BA Retail

GDP, GMP

ISO 14 001:2015 Environment Management System (Svensk Dos)

BA Consumer

Apply key principles from ISO 14001, ISO 26000, ISO 9001