Ask DRA to perform GxP audits for your pharmaceutical products. We will carry out GDP (Good Distribution Practice) or GMP (Good Manufacturing Practice) audits throughout your supply, production and distribution chains, including supplier qualification and evaluation, as well as doing onsite inspections and remote audits. We offer audits in the Nordics and central Europe, and together with virtual audits and our partner network, EuDRAcon, we can offer GMP audits all over the world.
Our GxP auditing services for pharmaceuticals include:
- Audit plans and reports
- Recommendations and classification of findings
- Gap Analysis of Quality Manufacturing Systems (QMS)
- Preparation for upcoming audits, e.g. from health authorities
GxP audits are an important part of marketing authorisation and marketing authorisation holders must ensure that they are regularly carried out. At DRA, we have the expertise needed to take care of your audits. Our experienced team will perform thorough audits of your products and processes to ensure that they meet the standards needed for continued compliance with your marketing authorisation. We will provide you with complete, detailed reports and all the necessary documentation. We can also support your team when they prepare for external audits from the authorities.
DRA offers GMP audits to Finnish product manufacturers, foreign product manufacturers, active substance manufactures, together with supplier qualification and evaluation, onsite inspections and remote audits. Our auditing services for GMP cover the whole product life cycle, including raw materials from approved suppliers, manufacturing sites, validated procedures, qualified equipment, trained personnel, analytics of finish products, packaging processes and release to the market.
Our auditing services for GDP cover the whole distribution chain from wholesaling to warehousing and transportation, and they also include onsite inspections and remote audits, as well as document reviews.
DRA Consulting is now PharmaLex Finland
As we are merging with the global service provider PharmaLex, our name has been changed to PharmaLex Finland.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.