[GMP Guideline] Pharmaceutical Inspection Cooperating Scheme / PICS
GMP 규정 및 가이드라인을 찾아보면 PICS(PIC/S) guideline이라는 말을 종종 듣곤 합니다.
PICS
PIC/S
Pharmaceutical Inspection Convention
Pharmaceutical Inspection Cooperating Scheme
영어가 부담스럽기는 하지만 PICS가 무엇인지 그리고 가이드라인을 찾는 법은 알아야 하니 사이트를 한 번은 방문해 봅니다.
PIC/S
New PIC/S Chairperson 11 - 12 November 2019 New PIC/S Chairperson (2020-21), Ms Anne Hayes (Ireland / HPRA), elected at Committee meeting of 11-12 November 2019, welcomed by preceding PIC/S Chairman (2018-2019), Mr Boon Meow Hoe (Singapore / HSA).
picscheme.org
PIC/S는
Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating
을 줄여서 표현한 약자이군요.
간혹 PIC/S 가입국에 어느 나라가 있는지 질문을 하곤 합니다.
링크를 클릭해서 찾아보면 됩니다.
https://picscheme.org/en/members
Members
By alphabetical order of the country / entity of each Participating Authority Argentina National Institute of Drugs Instituto Nacional de Medicamentos (INAME) Inspection Department Avda. Caseros 2161 – 1er Piso AR - C1264AAB Buenos Aires Accession to PIC
picscheme.org
그러면 PIC/S 가이드라인이라고 하면 어떤 것을 의미하는지 어디서 최신 버전을 찾고 어떤 파일을 보아야 하는지 찾아보겠습니다.
https://picscheme.org/en/publications
Publications
Publications Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents. The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GM
picscheme.org
링크의 Publications >>>> GMP guide를 클릭하면 아래 화면이 표시됩니다.
PIC/S GMP GUIDE(Introduction)
Part I: PIC/S GMP GUIDE - Basic requirements for medicinal products
Part II: PIC/S GMP GUIDE - Basic requirements for active pharmaceutical ingredients
PIC/S GMP GUIDE의 Related ANNEXES를 클릭하면 자주 보게 되는 문서로 이동합니다.
ANNEX1 Manufacture of sterile medicinal products
ANNEX8 Sampling of starting and packaging materials
ANNEX9 Manufacture of liquids, creams and ointments
ANNEX11 Computerised systems
ANNEX15 Qualification and validation
