Validation - status, trend and view

Author: Michael trained of: 28.04.2010Die still current FDA Guideline on general Principles OF Process Validation is now over 20 years old. The document from May 1987 stands for Industry from November 2008 before substantial contentwise changes and/or Neuentwicklungen.Die effects on the topic of the validation from the new Guidance for, stood in the focus of the PTS training service meeting on 14 April 2010 in Fulda. The adviser - Mr. Wolfgang H�hnel of the company Gempex GmbH - presented the fundamental changes and future possible developments in his lecture. Beginning with the representation of the current conditions in Germany, Europe and the USA, the adviser presented the planned and angedachten changes on the part of the FDA.Hinweis to time-rational: After conclusion of the commentating period in the summer 2009 (first commentating period: 20 January 2009 and second commentating period: 16. March 2009), was the publication of the final version actually at the end of the year 2009 planned, is however momentarily still open. Where do the changes lie in the core? Apart from the new formulation and adjustment of the definition for validation, the basic principles of the quality assurance are surely comparable and remain existing. New surely it is that a validation must be processable, in order to produce quality products steadily. From this all further revised versions are derived, which includes now more strongly the development up to routine production and actual routine production (life cycle model). As consequence the enterprises must surely again align themselves in their viewpoint: Of the pure punctual view (qualification and validation separated), for the continuous view of the entire processes (Process Design - process qualification and PQ - continuous process verification). Here is the next date: Guidance for Industry of the FDA Process Validation to 06.07.2010 http://www.pts.info/aktuell/topic.asp?kursid=1637In which points could change the validation significantly? The changes are in the detail: Away of a rigid stand, to one more holistic beginning. (Where in the future the classical DQ, IQ, OQ remains?) The result of the Process Design phase must be sufficient for routine production. A document in the context of a DoE (Design OF of experiment) is expected. Are retrospective validations in the future still acceptable? The conceptualness Process Qualification must hold in the enterprises introduction. The validation will be final not with the PQ. In the future a Continued Process verification follows. (Reference: Statistic Prozess�berachung/statistic methods/PAT). Change of the fundamental process understanding. Away of the classical validate v, to the process life cycle. (Process Design Process qualification - Continued Process verification) which are possible future beginnings? The Worst case during the PQ is not desired any longer. This is expected now in stage 1 of the Process Design. The process understanding is the center of attention more and more. The validation is not final with the last validation load. Further continuous measures are to be established in the context of a Process verification. The adviser presented the following open questions in the context of his lecture for discussion: What is to be done, if data from the process validation are not available in sufficient measure? How is the process qualification to look concrete? When can a validation be regarded as finally? How are many validation loads to be regarded as sufficient? What is to be done, if the process verification is not successful or is recognizable a drift? How would be to be gone around with if a classical retrospective validation beginning is demanded? A possible conclusion result at this time could be: The FDA focuses on a life cycle model. Process development and continuous process verification become on an equal footing with the process qualification. Process validation and qualification are more closely interconnected. Qualification without engineering? to 26. - 27.05.2010Risikoanalysen become ever more important. The potentially planned changes from the Guide for Industry were discussed intensively and discussed of advisers and participants. Many open questions remain at present still unanswered and the future will show whether the draft is as invariably published and as the European Union GMP manual will follow and the conversion to the national sets of rules is planned. Sterilisation: Furthermore practice and validation at the 22.06.2010Hilfreich were the validation examples for the production of a tablet, a biotechnology and a transportation validation with current requirement and possible future effect. Very interesting also the trip in the medicine product worlds and the conception and tasks of the GHTF were (global Harmonization task Force). Requirements of medicine products at the 28.09.2010Herzlichen thanks again at Mr. Wolfgang H�hnel for its engaged presentation, in which it expressed also its open and clear opinion! Here still some feedbacks of the participants: - Discussion of contributions of the participant Workshop of examples was goods structure and material possibility to open DiskussionEine the feedback us particularly well pleased: " The adviser could obtain contents of the Guideline well and understandably without Fachsprache" taken off;.�

This text was translated automatically.