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게시판-관련소식
뉴스레터 2013년 2월호
2013-04-12 by ISPE Korea
ISPEAK 2013년 2월호
1. GMP 소식
1) 의약외품에 관한 기준 및 시험방법 일부개정고시(안) 행정예고
- 식품의약품안전청 공고 제2013-9호
- 의약외품 허가(신고)된 품목 현황 및 유통 현실을 반영하여 의약외품 첨가제를 신설함으로써 공정서 수재품목 관리가 필요함
- 의약외품 외용제에 한하여 사용되는 첨가제(신설 540품목)의 기준․규격을 신설함
- 의약외품 각조의 기준․규격을 정비함으로써 의약외품의 품질향상이 기대됨 Continue reading
2) FDA NEWS RELEASE
- For Immediate Release: Feb. 7, 2013
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA offers new guidance on developing drugs for Alzheimer’s disease
- Draft proposal focuses on treatments for the early stage of the disease
Today, the U.S. Food and Drug Administration issued a proposal designed to assistcompanies developing new treatments for patients
in the early stages of Alzheimer’s disease, before the onset of noticeable
(overt) dementia. Continue reading
2.
- This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance.
2) Guidance for Industry E3 Structure and Content of Clinical Study Reports
3. ISPE 국내, 외 소식1) ISPE Updates and Expands Guidance for Testing of GxP Systems
- (TAMPA, FLORIDA, USA, 16 January 2013) – ISPE, a leading authority on best practices for the pharmaceutical industry, announced today that it has issued updated and expanded guidance to help pharmaceutical companies maximize testing efficiency of computerized and software-based systems that impact patient safety, product quality and data integrity. The second edition of the GAMP® Testing Guide has been revised to conform with GAMP® 5 concepts and terminology and reflect ICH Q8, Q9 and Q10, Quality by Design and Process Analytical Technology principles. It has also been expanded to include information on cloud computing, automated testing and non-linear development. Continue reading
2
) 국외 교육 일정- Join ISPE on 25-26 February in Tampa, Florida and learn how to improve
manufacturing efficiency, maintain product quality and improve GMP
compliance.
Most courses leverage ISPE Guidance documents produced by pharmaceutical
manufacturing industry professionals. These guides provide the practical, "real
world" information needed to build on best practices to meet and exceed current
regulatory requirements. Continue reading
* 일자 : 2013년 02월 25일 ~ 26일
* 장소 : Tampa, Florida USA
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