PR Inspections of operations and processes

 

PR  Inspections of Orion’s operations and sites conducted by third parties

 

Inspections

2007

2008

2009

Inspections

41

49

54

Critical observations

0

3

0

 

 

 

 

Regulatory authorities, customers, partners and contract manufacturing principals inspect and audit Orion’s supply chain and R&D operations related to pharmaceuticals, APIs and diagnostic products.In 2007−2009, a total of 144 inspections were carried out, 30 of them by regulatory authorities and 114 by Orion’s customers or partners. None of the inspections of regulatory authorities led to critical observations.

 

The three critical observations reported from audits in 2008 were made by contract manufacturing customers. Two of them were related to a cross contamination risk in pharmaceutical production. Orion quickly implemented actions related to facilities, equipment and cleaning as well as changes in the standard operating procedures (SOP), after which the risk was stated as eliminated. One critical observation was related to the validation of a coating phase of a product.

 

In 2007−2009, Orion received no critical observations from the audits performed by principals and clients.

 

 

PR  Inspections of material and service suppliers’ and contract manufacturers’ operations and sites conducted by Orion

 

Audits

2007

2008

2009

Audits total

165

136

116

Observations

3

5

1

Rejected

1

5

0

The guiding principles of the quality standards of Orion’s entire supply chain are based on full compliance with the EU-regulated good manufacturing and operating practices, efficiency and fluency of processes, product safety and consistent quality and high delivery reliability. By making inspections, Orion ensures that also third parties involved in its supply chain meet these requirements.

 

Audits conducted by Orion focus strongly on API manufactures, suppliers of raw materials and materials, contract manufacturers, and organisations providing clinical research services to Orion. In 2007 and 2008, Orion conducted a notably high number of inspections and audits in the facilities of API suppliers and contract research organisations to assess their eligibility as contract partners.

 

Orion has identified only a few critical shortcomings during the audits because agreements are made with partners only if they meet strict selection criteria and because regulatory authorities also ensure their compliance by audits. Audits performed by Orion in 2007−2009 resulted in altogether 6 rejections.

 

Updated Apr 18th 2011