Due to the more and more complex manufacturing of biologics there is an increased need for flexible manufacturing agreements between different companies for sharing or contracting development and manufacturing of biologics to optimise costs and risk. For that reason the FDA recently issued a new guidance. Read more here.
Eudralex Volume 10 has been amended with guidelines concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), and on EudraCT information to be made public. Read more.
The EMEA published a revised version of the "Reflection Paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation". Read more about the changes here.
In the recently issued document entiteled “API focused MHRA Inspections at dosage form manufacturers" the UK authority emphasised final dosage form manufacturers' responsibility relative to the GMP compliant API manufacture. Find out more.
The US Congress has introduced the so-called Food and Drug Globalization Act of 2009 to the US House of Representatives. This act contains points concerning the FDA's future orientation, some of which will have significant impact on the pharmaceutical industry. See some examples.
In the past fiscal year (October 2007 through September 2008) the FDA issued severly more warning letters due to GMP deficiencies than in the previous year. To find out more, please see the systematic analysis of the authority's warning letters.
The European Medicines Agency (EMEA) published an overview of comments it received on the Guideline "Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products". Please read here.
In the context of the ICH activities, the ICH Topic Q4B Annex 8, Sterility Test, General Chapter in Step 3 has now been published as well. It shows the results of the ICH Q4B Expert Working Group on the chapters Ph.Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests. Get more information here.
For several years now, the Pharmacopoeial Discussion Group and the ICH Q4B Working Group have been dealing with the harmonisation of the requirements laid down in the pharmacopoeias. In the meantime a number of ICH Topic Q4B Annexes have in fact been published. Read on here.
The WHO offers a guide to good manufacturing practice regarding training requirements. It is a very helpful document because there are a lot of practical examples available in the document (e.g. training SOPs, feedback questionnaires). Get more details here.
With regard to third party GMP audits, discussions frequently revolve around their acceptance. But actually the EMEA already defined in a Q&A document in 2006 that the drug manufacturer's QP has to select and authorise the third party. Get more information here.
Only five weeks after the publication of the European Commission's strategy for increasing the safety of medicinal products in the EU, on 15 January 2009 the FDA also released a package of three new guidelines for commenting. Read more.
In December we reported about the European Commission's package of measures intended to ensure the supply of safe, innovative and accessible medicines to European citizens. To get more information on the legislative proposals meant to stem the increasing number of counterfeit medicines, please read here.
The new "APIC Quick Guide for API Sourcing" includes suggestions on how suppliers of active ingredients and starting materials can be evaluated. However, it is also directed at the API manufactures themselves and gives them recommendations for confidence-building measures towards their customers among the pharmaceutical companies. Get the details here.
After the publication of the new FDA Process Validation Guidance, the companies will have to change their validation approaches. The classic 3 validation batches are no longer enough. With the help of a survey we intend to find out which conclusions the companies will draw. Furthermore, the results will be sent to the FDA within the framework of the commenting period. Find more here.