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 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.
GDP Interpretation: German Associations publish a Position Paper on Temperature Deviations
Different associations of medicinal products manufacturers and wholesalers have published a position paper and forwarded it to the regulatory authorities. Read more about the position paper on temperature deviations during the transport of medicinal products.
Medicinal Products stolen from Distribution Warehouses - an Increasing Risk
One of the main reasons for the revision of the EU GDP Guideline in November 2013 was securing the so-called supply chain from falsified medicinal products. A current case shows how important this new regulation is. Read more here about the robbery of medicinal products in a distribution warehouse.
GDP certification by accredited bodies and GDP audit by QPs - dangerous misunderstandings
With the publication of the new GDP Guideline in the year 2013 the legal requirements concerning the Good Distribution Practice have increased significantly. Therefore, more and more companies look for opportunities to get a GDP certificate. But this often leads to unnecessary costs. Read more in our news on GDP certificates.
The 2013 Guidelines on Good Distribution Practice apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines?
From July 1, the EU guidelines on Good Distribution Practice of medicinal products for human use (GDP Guidelines) will apply also in Switzerland. This is done by an Adaptation of Annex 2 of the Medicinal Products Approval Regulation (Arzneimittel-Bewilligungsverordnung - AMBV).
WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products
The WHO has published a set of technical guidance documents giving interesting and detailed information on temperature-controlled transport operations. Read more in the technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products.
From an FDA Perspective: The US Drug Supply Chain and Patient Safety
Ilisa Bernstein, Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care.