GMP 소식

「의약품등의 안정성시험기준」일부개정고시(안) 행정예고

식품의약품안전처 공고 제2016-186호

「의약품등의 안정성시험기준」(식품의약품안전처 고시 제2014-59호, 2014.02.12.)을 개정함에 있어 그 취지와 주요내용을 국민에게 널리 알려 의견을 구하고자 「행정절차법」 제46조에 따라 다음과 같이 행정예고합니다.
2016년 5월 4일
식품의약품안전처장

1. 개정이유
신약의 안정성시험기준을 국제조화하여 국내 의약품의 품질 경쟁력을 강화하려는 것임

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의약품 등의 안전에 관한 규칙

가이드라인

Current Good Manufacturing Practice for Medical Gases

I.INTRODUCTION

This guidance is intended to provide recommendations on how to comply with the current good manufacturing practice (CGMP) regulations as they apply to manufacturing, filling, transfilling, cascading, transferring, and distributing compressed and cryogenic medical gases. The recommendations should help manufacturers, fillers, and distributors comply with CGMP requirements to ensure the identity, strength, quality, and purity of medical gases. This guidance also provides recommendations to medical gas manufacturers on how to comply with certain aspects of the PDMA final rule (i.e., 21 CFR part 205). This guidance is not intended to be an all-inclusive listing of all relevant CGMP; instead, it covers certain sections of the CGMP regulations followed by a discussion of recommendations that the Agency considers acceptable means of meeting the requirements.

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Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA

This document is intended to provide guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) requirements.
This document is not intended to cover medical devices regulated by the Center for Devices and Radiological Health (CDRH) or foods or dietary supplements regulated by the Center for Food Safety and Applied Nutrition (CFSAN).

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