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Checklist for Implementation of GDP Principles - Part 8: Self-Inspections

According to Chapter 8 of the EU GDP Guidelines, self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures. In this article, you will find a checklist to verify the minimum implementation.

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EMA publishes new Q&A Document on Remote RP Activities

The European Medicines Agency (EMA) has published a new Q&A document on Remote RP activities. Remote activities by the Responsible Person may be permitted, but should occur within the EU/EEA or Northern Ireland in all cases.

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Questions and Answers from the ECA Webinar "GDP Update 2024" - Part 2

Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.

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Checklist for Implementation of GDP Principles - Part 7: Outsourced Activities

According to Chapter 7 of the EU GDP Guidelines, any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. In this article, you will find a checklist to verify the minimum implementation.

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Recommendations from EMA to strengthen supply chains of critical medicines published

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APIC: Best Practices Guide for dealing with Suppliers

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

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Questions and Answers from the ECA Webinar "GDP Update 2024" - Part 1

Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.

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Checklist for Implementation of GDP Principles - Part 6: Complaints, Returns, suspected falsified Medicinal Products and Medicinal Product Recalls

According to Chapter 6 of the EU GDP Guidelines, all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. In this article, you will find a checklist to verify the minimum implementation.

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Where to find GDP Certificates and Wholesale Distributor Authorisations

The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). But where actually to find reliable information on whether a particular company is in possession of such an authorisation or GDP certificate? Depending on the location of the company in question, certain databases are available for searching.

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Swissmedic publishes Technical Interpretation on Shipment under Quarantine

Swissmedic, the Swiss national authorisation and supervisory authority for drugs and medical products, has published a new document on "Shipment under Quarantine". It clarifies some situations in which a shipment under quarantine of active substances, intermediate drug products and finished drug products would be acceptable to inspectors.

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