To provide a guidance for a harmonised quality documentation of biological Investigational medicinal products in clinical trials, the EMA published the draft of a new guideline. More details can be found here.
The Committee on Internal Market and Consumer Protection of the European Parliament held a vote in March on numerous amendments to the draft directive from the EU Commission on the combating of counterfeit medicines. Read more.
In a draft paper, the European Medicines Agency (EMA) announced the reworking of their guidelines on process validation. Is this an attempt at European convergence with the FDA life cycle model? Read more here.
The European Commission has adopted two documents which coordinate and concentrate the activities of the monitoring and licensing authorities in all EU Member States and the EDQM, in the event of serious GMP infringements by the manufacturers of active pharmaceutical ingredients and clinical test preparations. What are the consequences for the pharmaceutical manufacturer for example, of the withdrawal of a CEP from a supplier of active ingredients? Learn more here.
Amendments to the draft guideline on combating counterfeit medicines have been proposed, stipulating obligatory GMP Regulations for excipients, as well as an official obligatory inspection of API manufacturers. Read more on this here.
In the draft revision of Section 1 (Quality Management System) of the EC GMP Guidelines, the topics of "process performance" and "state of control" also play a major role. These topics are also referred to in Step 3 of the process validation life cycle in the new FDA Guidance on Process Validation draft. Are the Europeans beginning to come into line with the FDA? Read more here.
Survey: Recently a draft revision of Chapter 1 (Quality Management) of the EU-GMP Guide has been published with some comprehensive changes. We would like to get your opinion on the proposed changes. Here you find our survey.
For the past ten years the European Compliance Academy (ECA) has been lead as a membership association. Now the organisation was transferred to a Foundation. To find out more about the foundation's purpose and structure please read here.
In a position paper of October 2010, the EFPIA comments on the draft by the European Commission for fighting counterfeit medicines. The EFPIA calls for measures that go beyond those laid down in the Commission's draft. Details on the EFPIA position paper can be found here.
The examination of centrally permissible trade medicinal products, co-ordinated by the EMA, showed that more than half of the products still had open issues, triggered, amongst other things, by the analysis methods used. You can read more here.
The FDA published the Guidance for Industry of "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes", providing recommendations to applicants on information to include in support of parametric release for sterile products. More details can be found here.
Once every year the ECA Advisory Board convenes to review past activities and to determine activities throughout the year and beyond. To find out more about the developments and planned acitvties please read here.
In February the EMA published the draft of a new Guideline for Real Time Release Testing (formerly Guideline on Parametric Release). The draft is open for comments until end of August 2010. More details can be found here.
The European Medicines Agency EMA announces the revise of its "Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation". The time allowed for submitting comments and change requests is running. Learn more here.
On 17 December 2009, the MHRA issued a public consultation procedure on the measures for strengthening the supply chains for medicinal products and for reducing the risks of counterfeit medicines. More can be found here.
As evidenced in the Warning Letter report issued for ECA, shortcoming in the handling of deviations and the implementation of CAPA systems are among the most frequent GMP deviations objected by the FDA. Read more.