QPharma has aligned all operational practices with the ICH Q10 Pharmaceutical Quality System guidelines. We take pride in our regulatory compliance record and have consistently passed Swedish, EU and US regulatory audits.

The guidelines of MPA, the Swedish regulatory authority, are widely accepted as stable and well conceived. Our QA department has extensive experience in the interpretation and implementation of these directives.

As a CMO, we are used to hosting customer audits as well.  We consider all audits – by regulatory authorities or customers – as a means to enhancing our Quality System and minimising future risk.




Furthermore, all risk-based decision making undertaken by QPharma is compliant with the ICH risk assessment guidelines (ICH Q9 Quality Risk Management
< http://www.ich.org/LOB/media/MEDIA1957.pdf> )

Supplier quality
Our QA staff regularly performs audits on API suppliers, as recommended by the ICH Q7 guidelines (<http://www.ich.org/LOB/media/MEDIA433.pdf>). Such audits provide the confidence that the API suppliers meet QPharma’s quality standards – reducing the need for QC testing of the API. The savings thus realised are shared with the customer.

Overseas quality
QPharma is experienced in testing products manufactured outside the EU. This allows QPharma to act as the releasing site for sale of such products within the EU. Our evaluation services include:

• Inspection of the non-EU manufacturing site
• Testing of the finished non-EU product
• Obtaining approval from the relevant EU regulatory body

Qualified Persons
QPharma have several Qualified Persons that fulfil personal qualities (e.g. integrity, maturity, open-mindedness, assertiveness, sound analytical skills and judgment) and a level of education as described in Directive 2001/83(2)/EC, combined with practical work experience within pharmaceutical development, manufacture, or Quality Assurance.