Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public
In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.
GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises
The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.
GDP for Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1248 of 29 July 2021
In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force. Read more in the summary of the most important aspects of the new document.
Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS
At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.
GDP for APIs used as Starting Materials in Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1280 of 2 August 2021
The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.
GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022
In light of ongoing difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, GDP certificates and time-limited wholesale authorisations for sites in the European Economic Area (EEA) are automatically extended until the end of 2022.
On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar "Protecting the medicines supply chain from falsified medicines". A link to the recording and updated information addressing some key questions received during this webinar have now been published on the MHRA Inspectorate blog.
The previously published Aide-Memoires for GDP and GMP Inspections regarding safety features are now accompanied by a third one: Aide-Memoire for Pharmacy Inspections. What are the obligations of persons authorized or entitled to supply medicinal products to the public?
MHRA Guidance for the Supply of Medical Cannabis Products
The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.
Record Number of Fake Drugs seized during INTERPOL Operation
During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.
Absence of Approved Storage Facilities leads to GDP Non-Compliance Report
The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.