Press Announcements 2018

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.

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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Hear FDA, EDQM and USP on New Requirements for Glass Packaging

The United States Pharmacopeia (USP) just announced to cancel and redevelop their previously published draft proposals on the glass general chapters. The latest developments will thus be in the centre of attention of a joint USP-Ph.Eur.-ECA conference on glass.

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New Edition of Defect Evaluation List for Containers made of Moulded Glass

Defect evaluation lists are good and generally accepted tools for deciding whether to accept or to reject packaging batches in the incoming goods inspection. As a delegate at the conference Glass meets Pharma jointly organized by USP, Ph.Eur. and ECA you will receive the defect evaluation list for containers made of tubular glass and the new edition of the defect evaluation list for containers made of moulded glass which will be published directly before the conference.

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ECA Foundation establishes new Interest Group on ATMPs

Advanced Therapy Medicinal Products (ATMP) are a new emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. Now the ECA Foundation has established the new ATMP Interest Group to support their members with information and guidance.

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ECA offers Training Courses and Conferences in 15 European Cities and one Event in the US

From Barcelona to Vienna, ECA offers 15 different European venues for its training courses and conferences. In addition a conference will be held in Chicago USA. Please find the different cities on the ECA webpage. Just click on the respective city picture for the events held in this city

GMP Search Engine - Finding what you look for quickly

If you want to find certain news, guidelines, courses, conferences or a comprehensive list of all quickly you may want to try the GMP Search Engine. It allows you to simply search all ECA databases, just guidelines, news or course and conference materials.

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GMP Conferences by Topics

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