Good clinical practice, GCP

GMP = good manufacturing practice GCP = good clinical practice. 

Whereas GMP as well as GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) are mainly acting on the operational or technical level, other quality assurance standards have been established by the International Organization of Standardization (ISO) to assure quality at the organizational level. Inadequate organizations with unclear tasks and responsibilities can severely influence the quality of products and services. 

Bonnes Pratiques Cliniques (GCP—Good Clinical Practice)... 

Good IT Practices are applicable for QA activities of all IT systems which acquire and process data from processes subject to GxP (x = C, D, L, M hence GCP [Good Clinical Practice], GDP [Good Distribution Practice], GLP [Good Laboratory Practice], GMP [Good Manufacturing Practice]). IT systems in this field are subject to QA if they... 

Ms. Koelman is currently global GLP/GCP (Good Clinical Practice) QA director within Solvay Pharmaceuticals. Previously, she was head of the GLP Quality Assurance Unit of Solvay Pharmaceuticals. She has been the leader of the project team that set up the local computer validation policy of Solvay Pharmaceuticals B.V. and also leader of the team responsible for implementing this policy in the company over a period of two years, before it was handed over to a permanent Computer Validation Committee. She has been involved in a number of validation projects of different types of systems, ranging from simple equipment to complex custom-built or highly customized applications. 

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