ECA's 14th Annual Review (2012)
Annual Review 2012
ECA Membership Development
After a slight decline in memberships in 2011 the number of professionals attending ECA courses and conferences and thus gaining memberships increased in 2012 again. By the end of the year the organisation counted close to 2.700 members from more than 60 countries.
Also, in 2012 the number of individual memberships came close to the number in 2011. Altogether, 38 colleagues signed up for the one year membership. The same was true for company memberships which were booked by 8 companies.
In addition, the organisation counted close to 50 members via the one year individual membership and close to 10 company membership from companies throughout Europe and beyond.
ECA Interest Groups further expand
The European QP Association continued to grow in 2012. By the end of the year more than 1.700 professionals had joined as members and over 220 were attributed the status associate members.
The Conference European GMPs and the Role of the QP was conducted the 2nd time in Bethesday, Maryland, USA. As in the year before delegates from all over the U.S. attended the conference and received an update on the latest development regarding European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations.
The Association regularly receives requests from members for some support for the daily work of a QP. One request frequently made is for a set of tools such as checklists, decision trees and workflows that could be used for structuring batch release decisions that would ensure all relevant points have been considered. However, release activities are site and product specific and may differ according to the structure of the Pharmaceutical Quality System (PQS) in place. For that reason the Association’s goal is not to develop a tool box containing a simple set of "plug in" checklists, but rather to establish a set of generic tools which then can be customised and amended by QPs as appropriate to their PQS and supply chain needs within their companies.
To get a brief, but informative snapshot of the level that QP Discretion is being applied across the EU, the QP Association also conducted a survey in cooperation with a colleague from RCSI in Dublin. The response rate was quite impressive: over 26% of the members from a good cross section of the industry provided feedback. The results highlighted how differently QPs are interpreting the discretion paper across both big and small sized companies. It was also very informative that there is a higher proportion of QPs who don't know if their authorities accept the discretion paper versus those QPs who actually apply it.
The Rapid Microbiology Method (RMM) Group also developed very positively. In 2012 it almost crossed the 400 members mark.
In 2012 the group also launched its new website with a new structure and new sections comprising additional information. This website now provides new possibilities for finding regulations, publications and articles about Rapid Methods. The public part includes information about the RMM group and membership, current RMM news as well as an archive of older news and forthcoming ECA events on microbiology. The login area of the website is exclusively reserved for members of the group, providing the discussion forum, best practice papers, publications and articles about RMM, RMM regulations, the RMM database with more than 30 systems to compare, useful links and, finally, surveys and results.
ECA's Analytical Quality Control Group had defined the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results as its first project. After the development of a SOP flow chart the group started to develop a Draft OOS SOP. This SOP was finally launched at the first time OOS Forum in June.
Since the FDA has revised its "old" Validation Guidance in 2011, validation has become a life cycle process with focus on process knowledge and process understanding based on scientific sound principles. With the EMA´s new Process Validation Draft Guidance the EU has also been moving to modern process aspects (e.g. life cycle process). To support the industry in implementing these new requirements ECA’s Process Validation Group developed Version 1 of a Good Practice Guide on Validation throughout 2012. With this document intends to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").
The Foundation’s latest Working Group – the GDP and Anticounterfeit Group – was established in March 2012. Its goals are to develop a set of guidance documents to assist the implementation of the new EU GDP Guidelines (2013/C68/01) by those involved in Medicines storage and distribution and to make the documents available free of charge to PQG and ECA members.
Version 14.0 of the Guideline Manager Software
In 2012 the ECA issued version 14.0 of the GMP Guideline Manager Software. This free of charge exclusive software for ECA members contains more than 1,100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations. The software comprises only those guidelines that refer either to GMP topics or have an influence on GMP (e.g. Notice to Applicants). The guidelines are displayed in a well-structured Guideline Tree. With the new software solution the PDF files are now integrated in the navigation tree. The software also offers a comprehensive search engine, allowing users to either conduct a keyword search in the complete database or in certain categories, e.g. only in FDA documents (note: this feature is not available for the online version).
The Software offers a "Guideline Tree" sorted by issuing authorities, and a second "Guideline Tree" sorted by topics. Users may use this Guideline Tree to find the applicable guideline, e.g. to “sterile manufacturing” or to “APIs”. Here you will find more information about the GMP Guideline Manager Software 14.0.
Version 10 of Good Practice Guide issued
The so-called Good Practice Guide has been established years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. In 2012, version 10 of this GMP matrix became available. The actual GMP Matrix confronting the three regulations has 21 pages. The matrix shows the requirements laid down for a given topic (such as cleaning or monitoring) in the respective regulation. The GMP Matrix is completed by the three regulations having further 530 pages. Despite the size of the reference book it is nevertheless composed in such a way it can easily be taken along for audits. That's why an ever increasing number of companies provide their auditors and quality assurance department personnel with the GMP Matrix.