The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. From January 2016 until today six GDP non-compliance reports have been published. Please read more about the GDP Non-Compliance reports.
Having in mind a proper needs assessment many companies in the field are considering the outsourcing of their logistic activities. But when it comes to the decision making definite decisions are required. Support provides a 12-steps guide for the outsourcing of logistics activities.
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.
After the second public consultation for the EMA Guideline on GMP for Advanced Therapy Medicinal Products there are still uncertainties and a persisting need for discussion of the current regulatory requirements.
The USP has released a revision of Chapter <1058> on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory. Get more information on the new USP Chapter <1058>.
The EMA published a refelection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs. It is part of the EU strategy that principles of Replacement, Reduction and Refinement must be considered systematically at all times when animals are used for scientific purposes in the EU.
In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?
In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This publication triggered a discussion about the Permitted Daily Exposure (PDE) values in the Pharmaceutical and even in the API Industry, especially regarding crosscontamination and cleaning validation. Now a draft of a Q&A paper from the EMA provides some concretisation.
The manufacturer of APIs and medicinal products Wockhardt in India received an FDA Warning Letter at the end of December 2016. During the inspection, it had been observed that both in GC and HPLC analytics OOS results were excluded from the official records. Get more information about the current Wockhardt FDA Warning Letter.
The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation".
In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more in the selection of FDA publications of the last months.
During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.