Good Distribution Practice (GDP) Consulting
Ensuring GDP compliance across your supply chain
Good Distribution Practice (GDP) Consulting
Ensuring GDP compliance across your supply chain
Good Distribution Practice (GDP) compliance has become an area of increased focus for regulatory bodies
The EU GDP guidelines (2013/C 343/01) describe the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. GDP compliance ensures that the storage, transportation and distribution of medicines is managed in line with product requirements at all times and that medicines are only delivered to the customer/addressee for whom they were intended. The GDP guidelines contain details on a number of aspects of the distribution process, including quality management systems (QMS), premises and equipment, documentation, operations, and outsourced activities.
Good Distribution Practice (GDP) compliance has become an area of increased focus for regulatory bodies
The EU GDP guidelines (2013/C 343/01) describe the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. GDP compliance ensures that the storage, transportation and distribution of medicines is managed in line with product requirements at all times and that medicines are only delivered to the customer/addressee for whom they were intended. The GDP guidelines contain details on a number of aspects of the distribution process, including quality management systems (QMS), premises and equipment, documentation, operations, and outsourced activities.
Good Distribution Practice (GDP) Consulting Services
Our GDP consultants help ensure that your company meets all the necessary requirements and standards across your supply chain, mitigating any risks associated with non-compliance. We can assist you with:
- Quality Management System (QMS) Design and Implementation
- Process improvement for Deviation, CAPA, and Change control
- Contract Responsible Person (RP)/RPi services
- Internal and External GDP Audits
- SOP & Documentation design and review
- Process Description, Implementation, Maintenance, and Support of Compliance Activities for IT Systems
- GDP Training
- Inspection readiness preparation, post inspection remediation, and CAPA planning
- and more!
We can provide tailored solutions suited for your needs. Reach out our team to discuss how we can help you.
Good Distribution Practice (GDP) Consulting Services
Our GDP consultants help ensure that your company meets all the necessary requirements and standards across your supply chain, mitigating any risks associated with non-compliance. We can assist you with:
- Quality Management System (QMS) Design and Implementation
- Process improvement for Deviation, CAPA, and Change control
- Contract Responsible Person (RP)/RPi services
- Internal and External GDP Audits
- SOP & Documentation design and review
- Process Description, Implementation, Maintenance, and Support of Compliance Activities for IT Systems
- GDP Training
- Inspection readiness preparation, post inspection remediation, and CAPA planning
- and more!
We can provide tailored solutions suited for your needs. Reach out our team to discuss how we can help you.
Our certified consultants help you ensure GDP Compliance
GDP Compliance is essential for all wholesale distributors of medicinal products. We can support you in reaching increased compliance with both EU and FDA GDP regulations to ensure your company is inspection ready at all times. Our consultants hold several years of experience and are GDP, GMP, GAMP5/CSV certified.
Jakob Juul Rasmussen
Partner, Head of Quality
Our certified consultants help you ensure GDP Compliance
GDP Compliance is essential for all wholesale distributors of medicinal products. We can support you in reaching increased compliance with both EU and FDA GDP regulations to ensure your company is inspection ready at all times. Our consultants hold several years of experience and are GDP, GMP, GAMP5/CSV certified.
Jakob Juul Rasmussen
Partner, Head of Quality
Are you interested in learning more about
how Pharma IT's GDP team can help you?
Reach out to learn more about our Good Distribution Practice (GDP) service offerings
Are you interested in learning more about
how Pharma IT's GDP team can help you?
Reach out to learn more about our Good Distribution Practice (GDP) service offerings