Press Announcements 2018

Pest Control Strategies - Guidance Document

Pest Control -  a topic with a lack of guidance? A topic with a lack of regard? A topic for outsourcing?  "Pest Control – from classic trap to digital control" - provides you answers to such questions.

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The Quality Challenge of Biological Raw Materials

How to effectively and constantly manage and control raw materials and excipients for biological drug products and drug substances is a question that concerns pharmaceutical companies, contract laboratories as well as suppliers of raw materials. Therefore, ECA, EBE and APIC joined together to pick up this issue and support their members with useful guidance and support on quality control and management of raw materials.

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ECA Analytical Quality Control Group (AQCG) Update

The ECA Analytical Quality Control Group (AQCG) was established in 2010 as part of the ECA Foundation. Learn more about the ECA's AQC Interest Group and its objectives.

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ECA Members Area - New Layout and Services

ECA Members have access to the Members Area on the ECA Academy Website. A new structure and layout will help you find the many exclusive services for ECA Members such as:

The Amazon Code to receive a 35% membership discount for ECA publications The GMP Discussion Forum for Members which allows you discuss your GMP related questions with colleagues A compilation of the Warning Letters issued by the FDA sorted by date and topic GMP Guideline Manager with several thousands of GMP related documents ECA Working Group Documents such as the SOP on OOS, OOE and OOT developed by the Analytical QC Group and more

Please access the ECA Members Area here. If you are not a member yet please find more information about ECA membership opportunities.

Current Activities of the European GDP Association

The European GDP Association is quite active in supporting its members with the implementation of the current GDP requirements. What has the GDP Association achieved in 2018 so far?

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Current Activities of the European QP Association

The European QP Association is quite active in supporting its members. Find out what the EQPA has achieved in 2018 so far.

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New ECA Guide Offers Examples/Templates for Efficient Qualification

Qualification and Validation regulations have changed in both Europe and the USA in recent years. Many pharmaceutical companies and suppliers are still using methods and documentation from previous practice although a risk-based approach has become a regulatory expectation. Also, many companies have very little integration between their activities, so the overall qualification and validation effort is complicated, expensive and time consuming. Therefore a team of pharmaceutical companies and suppliers have developed a new ECA Good Practice Guide: "Modern Qualification - A guide to effective qualification based on Customer--Supplier Partnership". The first public draft of this guide with examples/templates as appendices will be presented at ECA´s Modern Qualification and Validation Conference, 11/12 September 2018, Berlin.

Supplier Exhibition at the ECA Continuous Manufacturing Conference

The pharmaceutical industry's interest to move from batch to continuous manufacturing is clearly increasing. The ECA therefore invites pharmaceutical companies as well as equipment and system suppliers to an information exchange at the Continuous Manufacturing Conference in Barcelona. On 27/28 November 2018 we'll focus on technology, process control, quality assurance and regulatory approval for the continuous manufacture of solid dosage forms. Companies like Janssen Pharmaceuticals, Pfizer, TEVA, GSK und Hovione that already gained experience with continuous processes will present their approach. Exhibitors at this conference will have the opportunity to introduce new technologies in short presentations at the conference. Please note though, that space and presentation slots are strictly limited and are subject to ECA approval. You can find the detailed programme brochure and a form for the registration of a table top stand on ECA's webpage.

How to document a Product Transfer? Get Example Templates!!

As a participant of the GMP training course "Product Transfer" you will receive a USB-Stick with example documents, templates and guidelines for site change projects.

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Glass Packaging Defect Evaluation List: New Edition 2018

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Molded Glass will include an appendix with example pictures of specific defect characteristics.

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GMP Conferences by Topics

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