ISPEAK 2012년 11월호

 

1. GMP 소식

 

1) 「의약외품 품목허가·신고·심사 규정」일부개정 고시안 행정예고

식품의약품안전청 공고 제2012-228호

의약외품 품목허가·신고·심사 규정(식품의약품안전청고시 제2011-5호, 2011. 2. 1)을 일부 개정함에 있어 국민에게 미리 알려 의견을 수렴하고자 그 취지, 개정 이유 및 주요 내용을 「행정절차법」제46조에 따라 다음과 같이 공고합니다.

http://www.kfda.go.kr/index.kfda?mid=54&pageNo=1&seq=18873&cmd=v

 

2) Drug Establishments Current Registration Site

IMPORTANT CHANGES TO THE TIMING OF ANNUAL REGISTRATION

The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) where they manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S.. Establishments must be registered within 5 days of beginning operations.

(21 CFR 207.21(a) and 207.40 and FD&C Act sections 510(c), (d), & (i)).

In addition, establishments must renew registration annually. (FD&C Act sections 510(b) & (i)).              

http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm

 

2. 가이드라인 소식

 

1) Center For Drug Evaluation and Research List of Guidance Documents

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes, regulations, or both. For information on a specific guidance document, please contact the originating office (see footnote 1 in recent guidances), or contact the Division of Drug Information in the Office of Training and Communications.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm310704.htm

 

 2) High Purity Water Systems

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

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.

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm

 

3. ISPE 소식

 

1) ISPE 2012 Annual Meeting

‣ New Sessions featuring Industry and Regulatory Leaders at ISPE 2012 Annual Meeting

       ‣ 일자 : 2012년 11월 11일~ 14일

       ‣ 장소 : San Francisco, California USA

       ‣ 홈페이지 : http://www.ispe.org/events/2012-ispe-annual-meeting3

 

2) 국내 하반기 교육 일정

       ‣ Update CGMP Highlights

       ‣ 일자 : 2012년 11월 21일~ 22일

       ‣ 장소 : 차세대 융합기술 연구원 세미나룸 I

       ‣ 홈페이지 : https://www.ispe.or.kr/

 (교육 및 훈련>교육안내)

 

  3) 국외 교육 일정

      ‣ 2012 San Francisco Training

        Practical Application of Computerized Systems Compliance GAMP® 5 (T11)

        Quality Risk Management (T42) - New Course!

        Turning QbD into a Practical Reality (T43) - New Course and Guide!

        일자 : 2012년 11월 13일 ~ 14일

        장소 : San Francisco, California USA

        홈페이지 : http://www.ispe.org/2012sanfranciscotraining