▣ GMP 소식

" Issue Draft Guidance for Industry : Bioanalytical Method Validation

This guidance provides general recommendations for bioanalytical method validation. The recommendations can be modified depending on the specific type of analytical method used. Continue reading

"의료기기 제조 및 품질관리기준 일부개정고시"

잠재적 위해도가 거의 없는 1등급 의료기기에 대하여 의료기기 제조 및 품질관리기준에 대한 적합성 평가를 적용 제외함으로써 업체의 시장조기 진입 및 심사 비용절감 효과와 행정청에서의 고위해도 의료기기에 대한 효율적인 집중관리를 도모하고자 현행 제도를 개선하려는 것임. Continue reading

▣ 가이드라인 소식

Current Good Manufacturing Practice for Medical Gases

Comments and suggestions regarding this draft document must be submitted within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Docket Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. All comments must be identified with the docket number listed in the notice of availability that publishes in the Federal Register  Continue reading

Computerized Systems in Drug Establishments(2/83)

FEBRUARY, 1983

National Center for Drugs and Biologics

and Executive Director of Regional Operations

REFERENCE MATERIALS AND TRAINING AIDS FOR INVESTIGATORS

U.S. DEPT. OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION

Division of Drug Quality Compliance (HFN-320)
Associate Director for Compliance
Office of Drugs
National Center for Drugs and Biologics  Continue reading



▣ ISPE 국내, 외 소식

ISPE 한국지부 사무국 주소변경

   - 변경 전 주소 : 충북 청원군 오창읍 양청리 818-5 대운프라자 503-1

   - 변경 후 주소 : 충북 청원군 내수읍 덕암길 10 충북보건과학대학교

As an ISPE Member, you can participate in the creation of science-based regulations and guidelines.

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE is the neutral organization through which industry and global health organizations collaborate to improve product quality and patient health.

▣ 연간 회원 및 스폰서 안내