Quality management and compliance services:
Pharmaceutical quality management system and GDP compliance
Ensure GDP compliance throughout the supply chain
As a wholesale distributor of medicine in Scandinavia, your quality management system must adhere to the extensive documentation requirements of the EU’s Good Distribution Practice (GDP) guidelines. Not only does a good pharmaceutical QMS help define the roles and responsibilities for the correct distribution of your products; it also ensures that your processes are compliant and inspection-ready.
Our experienced GDP consultants help wholesale distributors in Denmark and other Scandinavian countries develop, implement and manage GDP-compliant QMS systems and functions as the responsible person (RP) for small and medium-sized distributors.
Experienced quality management system consultants
20 years of compliance experience
Our depth of knowledge is accumulated through more than 20 years of working with quality compliance in the pharmaceutical industry.
Legal expertise
Our consultants provide guidance, interpretation and advice on compliance matters based on their strong expertise in pharmaceutical and food supplement regulation.
Fully updated local experts
Based in Denmark we are always up to date on changes to laws and regulations across the Scandinavian jurisdictions.
Part of EuDRAcon
As part of the pan-European network EuDRAcon, we can draw on local compliance providers in all EU countries.
Tina Nørgaard MSc. Pharm, QA Manager
Quality management services
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Appointing a responsible person (RP) with sufficient GDP training is mandatory for wholesale distributors of medicine. Our consultants have the necessary training to act as your GDP responsible person as well as a thorough understanding of the Scandinavian markets and the practices of the local competent authorities.
The RP will be your responsible contact person towards authorities and subcontractors and will manage deviations and CAPA reporting as well as any recalls and yearly mock recalls.
Interim and long-term RP collaborations
We cover interim RP services as well as long-term GDP compliance and develop a compliant QMS for you. If preferred, we align your corporate system to Scandinavian legislation and manage it for you. -
A pharmaceutical quality management system (QMS) is a set of standard operating procedures (SOPs) and practices that ensure compliance with quality standards.
Our experienced GDP quality management consultants develop your QMS based on risk assessments of your supply chain and make sure your distribution practices comply with the GDP guidelines.
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Our consultants have extensive experience with implementing QMS in the pharmaceutical industry. Our systematic approach ensures that your QMS is thoroughly integrated into daily operations and that all relevant staff receive the required GDP training.
For supply chain subcontractors, we ensure that GDP audits are performed according to the company’s audit plans.
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We continually monitor the quality management system, checking that SOPs and documentation requirements are being followed and evaluated for improvements.
We perform an annual management review to ensure compliance with legislation and quality objectives.
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We perform internal audits to help you stay inspection-ready. We also perform third-party audits of your subcontractors or joint audits with companies similar to yours.
Internal audits
Qualification audits
Subcontractor audits
Joint GDP audits
“We rely on PharmAdvice to help us stay compliant and to notify us early if any adjustments are needed. This helps us maintain our license to operate in key markets like Scandinavia and the EU – with additional support from their network of service providers. And we rely on PharmAdviceʼs medical consultant in matters of adverse events globally,ˮ says Kristian Uggerhøj.
Client: Kristian Uggerhøj, CEO, Alkalon A/S
Services: Pharmacovigilance, Regulatory Affairs
Collaboration: 2011-
5 essential components of a GDP-compliant QMS that is actually useful
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If GDP compliance is to be more than a mere paper exercise, the system must be deeply embedded in the organisation, starting with the management.
A quality policy based on the GDP guidelines may frame the overall scope and objectives of the QMS and ensure alignment of the organisation’s quality efforts and the QMS SOPs. Continuous training may help anchor the quality management throughout the organisation.
But the compliance measures must be underpinned by managerial focus and commitment and a genuine understanding of the legislation for the QMS to become a useful tool for strategic quality management.
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The gap analysis identifies where your current distribution practices do not meet GDP requirements. Establishing a clear overview of distribution issues minimises the risk of authority findings and enables fast action on critical gaps.
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The risk assessment identifies potential risks in your supply chain. Knowing the risks enables you to mitigate them and reduce their likelihood. The risk assessment is revisited whenever legislation, equipment, suppliers etc. change.
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Detailed SOPs for all vital processes, including change control management and deviation handling and CAPA management (Corrective and Preventive Actions), are essential to ensuring consistent operations and systematic, ongoing documentation of your distribution practices. They help minimise errors, guarantee traceability and make it easier to onboard new staff.
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Setting up training programs and procedures to monitor and document all GDP training ensures that all relevant members of staff are on track with current legislation and company processes. Yearly monitoring and planning are decided through management reviews.
Need help establishing and implementing a compliant QMS?
Fill in the form, and we will contact you to schedule a discussion of your needs.