The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. The basic principles of the chapter have been unchanged; however a few new approaches have been added. Read more.
After a selection process over 15 months and out of 20 vendors the EFPIA and the European Medicines Verification System (EMVS) has chosen the software company Solidsoft with the cloud-based Windows Azure from Microsoft. You will find everything else in this news.
Scientists at the U.S. Food and Drug Administration (FDA) have reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can mediate lung injury. Read more.
The APIC has published a guideline for the management and the qualification of contract laboratories. The guideline is supplemented by detailed checklists and questionnaires, which are very useful for practice. For more information read this news.
Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. But how to reduce testing and comply with GMP? Read more in our GMP News
What provisions does a pharmaceutical company have to make today to meet the future requirements of the EU directive against counterfeit medicines? The EFPIA "guidance for manufacturers" shows what is required and what is necessary so that in future the distribution channels for medicines are safe. Read the details in this news.
Under certain circumstances unapproved bulk or finished products can be imported in the United States before granting the marketing authorisation. For this purpose the FDA recently described a new standardised approach in a draft of a "Guidance for Industry". What pharmaceutical companies have to consider prior to launching their products in the United States you can read here.
There are no specific provisions regarding the traceability of medical devices in the European regulatory framework for medical devices. That’s why the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". Read more.
As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.