행사/교육
FIP Quality-International 2007 Conference: Critical process parameters in the manufacture of APIs, biologicals, tablets and parenterals
- 등록일2007-10-22
- 조회수2861
- 구분 국외
- 행사교육분류 행사
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주관기관
The International Pharmaceutical Federation (FIP)
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행사장소
London, RPSGB HQ
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행사기간
2007-11-26 ~ 2007-11-27
- 원문링크
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첨부파일
FIP Quality-International 2007 Conference: Critical process parameters in the manufacture of APIs, biologicals, tablets and parenterals
Meeting Information
Location : London, RPSGB HQ
Address : 1 Lambeth High street
City: London, NA SE1 7JN
Country : United Kingdom
Telephone : 020 7572 2640
FAX : 020 7572 2506
Email : science@rpsgb.org
Website : http://www.rpsgb.org/worldofpharmacy/events/
Meeting Sponsor Information
Company : The International Pharmaceutical Federation (FIP) in partnership with the Royal Pharmaceutical Society of Great Britain
Contact : Julie Churchill
Title : Ms
Department : Science
Telephone : 020 7572 2640
Email : science@rpsgb.org
Description of the Event :
Pharmaceutical manufacturing is going through a major transition from quality assessment by testing the product at the end of manufacture to the more holistic control strategy of quality by design and Process Analytical Technology. This change, however, requires an enhanced scientific understanding of the pharmaceutical processes involved in product manufacture and in particular a scientific appreciation of the criticality of each process step.
With the advent of quality by design therefore, each pharmaceutical company will need to implement science and risk based approaches to evaluate its own processes, determine their critical steps and necessary controls and establish a design space for each process. It is essential therefore, that companies have a common understanding or else it is highly likely that, as a result of different scientific insights and/or interpretations of criticality, each company may have a different interpretations of the critical process steps and the necessary controls, even for very similar processes. The goal of this conference is to reach a better understanding of the concept of criticality in general, and how this can be applied to the most common pharmaceutical manufacturing processes.