In our Newsletter we reported about a so called Gold Standard for the qualification of a Responsible Person for GDP. Now the MHRA cites the standard on their webpage. Read more about the Gold Standard.
Since the end of the comment period for the "Draft Consensus Guideline" published in 2013, the ICH Q3D guideline has been in process for half a year. One may wonder whether the final document will be published this month as initially planned. This has consequences on other important national regulations. Read more here.
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.
The EMA has recently added an interesting question to its Questions & Answers section. How acceptable is filtration of particles prior to the administration of a medicinal product for parenteral use? Read more.
Heraclitus once said: "There is nothing permanent except change". This statement is even true for the rather conservative GMP environment. What can we still expect for 2014? The answer to that question can be found in a work plan of EMA's GMP/GDP Inspectors Working Group.
Current questions and answers about the framework for herbal medicinal products and traditional herbal medicinal products are addressed in a new EMA/HMPC document. The document also addresses herbal medicinal products which don't have a European tradition. Read more in this News.
The Danish Health and Medicines Authority has published a document which shows that the EU has left enough leeway for the implementation of EU regulations. This would certainly be desirable for other Member States as well. Read more.
The European Medicines Agency (EMA) has published the Template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain - "The QP declaration template". Read more.
An APIC multinational working group has compiled a new guidance on cleaning validation with the title "APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Publication date is May 2014 and the document can be downloaded from the APIC website. Here you will find a summary description of the document.
A judgement of the EU Court of Justice (Sixth Chamber) from 10 April 2014 on the suspension of the marketing and the withdrawal of certain medicinal products batches has been published. The judgement highlights the importance of the decisions taken by the EU Commission. Read more about the judgement of the Court and the consequences for the GMP world.
The EMA GCP Inspectors Working Group has published the Procedure for coordinating GCP inspections requested by the CHMP describing the the different steps of the Good Clinical Practice (GCP) inspection process. Read more.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures has revised the Q/A-List for the Submission of Variations adding a question and answer regarding the submission of the results of confirmatory stability studies on production-scale batches. Read more.
Essential oils used as API in herbal products lead to - from a regulatory view - a wide range of questions. At the moment, there is no EMA/HMPC Guideline. Now, the final "Reflection Paper" has been published. Moreover, current questions and answers about essential oils have been added to a Q&A document. Read more in the News.
The pressure on India is getting bigger because of GMP deficiencies found during inspections. An article of the news agency Reuters summarised impressive information on the topic. Read more here about the Reuters article.
When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field. Read more here about the Concept Paper
The Active Pharmaceutical Ingredients Committee (APIC) has recently published a practical guide about good distribution practices for pharmaceutical APIs. Read more here about the new "How to do" document.