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Process improvements and in-person monitoring help U.S. pharmaceutical company achieve on time for Phase III clinical trials

Syner-G

SEPTEMBER 20, 2023

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. Download The Case Study The post Process improvements and in-person monitoring help U.S.

Process Improvement 40
Process Improvement Pharmaceutical Companies Pharmaceutical Companies Documentation 40
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How to conduct product quality review in pharmaceutical

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. Trending will help identify product and process improvements. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented.

Documentation 52
Documentation Packaging Method Validation Process Improvement 52
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