As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? Which part do the Heads of Production and QA play for the signatures? Read more about the answers provided by the EU GMP Guide.
In two recently published documents, the ICH has informed about the establishment of an "Implementation Working Group" for ICH Q3D "Elemental Impurities" and the elaboration of training materials on the requirements of this guideline. Read more here.
After the transition of the ECA Visual Inspection group from a working to an interest group, it is now possible to join the group for free. Group members have access to the full site content including the download of the best practice paper on visual inspection. Read more.
In the Official Journal of the European Union from 9 August 2014, two corrigenda to the counterfeit directive have been published with regard to the prevention of the entry into the legal supply chain of falsified medicinal products. Please read more details here in this News.
In a publication in the Pharmacopeial Forum, the USP describes the future USP chapters planned for Good Distribution Practices (GDP). The new Chapter <1083.4> focuses on the supply chain integrity and security. More information can be found here in the News.
The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL inspections. To find some of these questions and answers by Dr. Tobias Posset (Head of Production Support at Roche Diagnostics) please read here.
The USP describes in an article of the Pharmacopeial Forum the future requirements for plastic packaging systems. Here, the importance is laid on the selection of suitable, safe plastic materials and the verification of potential interactions. More information can be found here in the News.
The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a very helpful document is available from the EU Commission which provides answers to a number of questions for GDP implementation. Read more about the Good Distribution Practice Q&As here.
The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide). Click here to read more about the GDP interpretation