Press Announcements 2015

New Service for ECA Members at no costs

To support our Members we have enhanced the service in the ECA Members Area. You will not only find the online Version of the Guideline Manager with more than 1,100 GMP Guidelines, but also a Warning Letter directory containing all GMP related Warning Letters from FDA. In addition you will find detailed analyses of recently published Draft or Final Guidelines to provide you with more information about new requirements. All articles from the GMP Journal are available online, as well as selected articles from the IPQ Journal. We will publish final ECA Guidance documents in the members area as well. Currently you can access the SOP on Out of Specification Results (OOS). On a regular basis you will find new highlight presentation from ECA events online. Just recently we have published a presentation held by Scott Aldrich from the USP Dosage Forms Experts Committee. He spoke at the ECA Particles Conference about the USP Chapter on Particles. We also added a presentation from Klaus Eichmueller, EU GMP Inspector who gave a presentation about the new Annex 15 to the EU GMP Guide. You can access the ECA Members Area here.

New ICH Q7 How to Do Guide Version 08

Just recently the ICH Q7 How to Do Guide developed by APIC/CEFIC has been updated. The new Version 8 is now available. In our GMP News we informed about the main changes in the ICH Q7 How to Do Guide. The present document aims at providing practical advice for the implementation and maintenance of GMP standards during the production of active pharmaceutical ingredients concerning those provisions of ICH Q7 that require further interpretation. The "How to do" document is a "living" document as it is revised in irregular intervals in order to keep pace with the constantly changing state of scientific and technical knowledge. In our book shop you can purchase a booklet which contains the full text of ICH Q7 in a side by side comparison to the ICH Q7 How to Do Guide from APIC/CEFIC.

Validation Approach of Bioassays using statistical Method - Part of PharmaLab 2015

In recent years PharmaLab covered several times bioassays, their implementation and the challenges in establishing them. An important aspect in the validation of such assays is the proper statistical approach and the correct statistical analysis. That's why PharmaLab 2015 also offers a special session "Validation Approach of Bioassays Using statistical Methods" on 11 November. In this workshop, you will get information on the necessary experiments and statistical analyses for calculating the biological activity and for evaluating the validation parameters. In addition, the respective guidelines will be presented and discussed. Finally, case studies will show the practical approach. Please see the programme for further information.

ECA Foundation announces new Board Structure

So far the ECA Foundation Advisory Board comprised 10 professionals from industry and authorities. During their last Board Meeting, on 10 June 2015, the Board set the course for the future with a new board structure.

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Provide your feedback to EMA and FDA - participate in ECA`s Quality Metrics Survey

The US FDA plans on publishing a Guideline on Quality Metrics soon, and other European Regulators are discussing this option as well. Quality Metrics will help regulators to plan GMP inspections and to monitor the GMP status of pharmaceutical and API manufacturing sites. What do you think about this initiative? Your anonymous feedback through our survey will help us to provide information to EMA and FDA. It will just take 5 minutes. The results will be presented at a pre-conference session on Quality Metrics on 8th June with FDA, EMA and MHRA speakers.

New GDP Certification Scheme

Good Distribution Practice has been closely linked to Good Manufacturing Pracitices. Medicinal Products need to be handled by qualified personnel. Chapter 2 of the EU GDP Guideline defines that personnel involved in GDP activities should “receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme.” Furthermore the GDP Guide states that “a record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.” The certification Programme of the ECA Academy aims at providing the necessary knowledge for personnel involved in GDP activities. Read more about the new ECA certified GDP Compliance Manager.

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ECA Foundation with New Webpage and New Interest Groups

The ECA Foundation was founded 15 years ago and has been developing to Europe´s leading organisation in the field of GMP and Regulatory Compliance. In order to provide a better picture of the comprehensive activities of the ECA Fondation a new webpage has been developed. Please read more here.

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GMP Conferences by Topics

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