When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?
ECA GDP Association represented at 5th Annual International GDP Conference in Serbia
The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."
Brexit: Acting as a Responsible Person (import) (RPi)
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Guidance called "Acting as a Responsible Person (import) from 1 January 2021". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi.
GDP Monograph for Active Substances: Interactive PDF now available
The "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published recently as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. An interactive PDF of the document is now accessible free of charge in the member's area of the European GDP Association.
New Post in the MHRA Inspectorate Blog on Quality Risk Management in GDP
Quality Risk Management (QRM) is a fundamental requirement in the Good Distribution Practice (GDP) environment. It is applicable to a variety of activities and processes, such as temperature mapping studies, supplier qualification, deviations, and change control. In this context, a new post, entitled "A Practical example of applying Quality Risk Management in GDP - Transportation Risks", has been published in the MHRA Inspectorate blog.
The Responsible Person: What are the Key Elements which should be covered a Job Description?
The EU-GDP Guidelines require that wholesale distributors have to appoint a responsible person (RP) for GDP. A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. But what are the elements which should be covered in such a job description?
The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.