Integrating Software Into Hospital Quality Structures: What Practices Do Pharmaceutical Inspector Co-Operation Scheme (PIC/S) Guidelines Recommend?-Reference-Cited by-同舟云学术

Integrating Software Into Hospital Quality Structures: What Practices Do Pharmaceutical Inspector Co-Operation Scheme (PIC/S) Guidelines Recommend?

Published:2023-11-14 Issue:1 Volume:40 Page:50-54
ISSN:8755-1225
Container-title:Journal of Pharmacy Technology
language:en
Short-container-title:Journal of Pharmacy Technology

Author:

Scione Fabiana¹^ORCID,Abdelmaula Khaled Yousef¹,Balzan Dustin²,Falzon Stephen²,Sultana Janet²

Affiliation:

1. Deenova s.r.l, Birkirkara, Malta

2. Mater Dei Hospital, Msida, Malta

Publisher

SAGE Publications

Subject

Pharmaceutical Science

Link

http://journals.sagepub.com/doi/pdf/10.1177/87551225231210723

Reference9 articles.

1. Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme. Good practices for computerised systems in regulated “GXP” environments. Published September 9, 2007. Accessed October 2, 2023. https://picscheme.org/docview/3444.

2. National Archives and Records Administration. Directive 2001/83/EC of the European Parliament and of the Council. Published 2001. Accessed August 5, 2023. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20121116:EN:PDF.

3. National Archives and Records Administration. Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. § 211. Published 1978. Accessed August 5, 2023. https://www.ecfr.gov/current/title-21/part-211.

4. National Archives and Records Administration. Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. § 820. Published 1978. Accessed August 5, 2023. https://www.ecfr.gov/current/title-21/part-211.

5. National Archives and Records Administration. Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. § 211. Published 1978. Accessed August 5, 2023. https://www.ecfr.gov/current/title-21/part-211.