Good Distribution Practices News

21.06.16

Current Issues of GDP Oversight

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.

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21.06.16

GDP Non-compliance Report issued in EudraGMDP

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.

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20.04.16

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.

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13.04.16

GDP: MHRA concerned about Supplier Qualification

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.

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23.03.16

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.

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09.03.16

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.

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16.12.15

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.

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18.11.15

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.

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14.10.15

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.

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16.09.15

IMPs: How do GDP Guidelines apply?

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?

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09.09.15

GDP Non-Compliance Report for Czech Company D-Pharm

On 21st July 2015 the competent authority of the Czech Republic has issued a EU GDP Non-Compliance report to a wholesale distributor. Please read more about the GDP-Non Compliance Report.

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24.06.15

GDP Guidelines now also valid in Switzerland

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).

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10.06.15

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.

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03.06.15

EU GMP: new Annex 21 on the Way

The GMP/GDP Inspectors Working Party is planning to implement a new Annex 21 to the EU GMP Guidelines focussing on the import of medicinal products.

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27.05.15

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.

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