The Qualified Person: also responsible for Distribution Activities?
In his talk on "Detection of Falsified Medicines and how the QP can support this", Paul Hargreaves (MHRA), explored some facts that a QP should know when it comes to the falsification of medicines.
Do you know the Saudi GDPs? And the Role of the Responsible Person?
The GDP Guidelines of the Saudi Food & Drug Authority (SFDA) have been published in English and are similar to those in the EU. But there are also some differences between the Saudi and the European GDP Guidelines.
Current Status of GDP Implementation and the Role of the RP - an Overview
To find out where the EU GDP Guidelines have been implemented already as a national rule ECA's GDP Working Group set up a survey amongst its members. Here is a summary of the feedback.
In a recent blog of the MHRA, the inspectorate looks at temperature mapping. It seems that "some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines".
Refrigerated Medicinal Products: Things to consider
Based on the experience made in GDP inspections, the MHRA has published things to consider for the transportation and temperature management of refrigerated medicinal products.
Storage and Transport: New USP Chapter for Investigational Drug Products
The USP has proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters, focusing on investigational drug products.
Example by Inspectorate for Handling Temperature Excursions
In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU.
The definition for "pre-wholesale" is neither present in the EU GDP guidelines nor in the GMP requirements from Eudralex. However, this concept does exist and some things have to be considered.
Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues. Read more here about GDP monitoring.
The competent authority of the Czech Republic entered in total three GDP non Compliance Report into the community database. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often. Please read more about GDP Non Compliance Reports.
ECA/PQG Working Group finalises GDP Interpretation Guide
Three new chapters of an interpretation of the EU-GDP Guidelines with temperature mapping templates have been published. Please read more about the new Guidance Chapters of the ECA/PQG Working Group.
In a recent blog, the U.K. Medicines and Healthcare Products Regulatory Agency reminds companies to assure their supply chain integrity. To support stakeholders, a three step guidance is given.
ECA/PQG Working Group publishes Chapter 8 of the GDP Interpretation Guide
A new chapter of an interpretation of the EU Good Distribution Practice Guide (GDP) has been published jointly by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG). Please read more about the new Chapter 8 of the GDP interpretation.
ECA publishes Code of Practice: The Responsible Person for GDP
A Task Force initiated by the ECA Foundation has developed a Guidance document which aims to support Responsible Persons (RPs) for Good Distribution Practice (GDP). Please read more about the Code of Practice for RPs.