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Regulatory Roundup: FDA Published The International Conference On Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.
Regulatory Roundup
FDA published the International Conference on Harmonization (ICH) S9 guideline as a guidance for industry Nonclinical Evaluation for Anticancer Pharmaceuticals. The guidance is meant to assist in the “design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals” and provides information on nonclinical evaluations that support the development of clinical-trial pharmaceuticals aimed at treating advanced-stage cancer. ICH representatives adopted the guideline in October 2009.
The International Society for Pharmaceutical Engineering (ISPE) released a new guidance document for good automated manufacturing practice (GAMP), GAMP Good Practice Guide: Manufacturing Execution Systems (MES): A Strategic and Program Management Approach. According to a news release from ISPE, the new guide recommends a life-cycle approach for developing and implementing MES for regulated manufacturing. The guide addresses how to achieve control and compliance in the project and operational phases.