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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

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. Challenge Syner-G was contracted by a U.S.

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Harnessing continuous improvement in the CAPA process

European Pharmaceutical Review

The optimised framework aims to overall, drive higher product quality and improved patient safety. Summarising recommendations and best practices for CAPA process improvement, this whitepaper uses data collected from a pilot suggested in the MDIC’s initial whitepaper that proposed the framework.

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Decoding the Role of AI in Private Equity Deals

Fuld & Company Blog

Streamlined document review: AI-powered platforms revolutionize document reviews by automatically categorizing and analyzing vast volumes, streamlining due diligence, and potentially improving accuracy and depth.

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How to conduct product quality review in pharmaceutical

GMPSOP

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.

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Understanding Large Molecule Drug Development: From Biologics to Market

Syner-G

Both processes are evolving to enhance product development and output. Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

Additional documents included each month. record who had found the incident first time) Corrective and preventive action process Embed Code 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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Data and digital is a force to reckon with when it comes to India

Express Pharma

People may not be dealing with patients, but somebody who is doing case processing of an adverse event, must not look at it only as a document to fill in data. Bengaluru is a very nice sandbox environment, when you run transformation projects like process improvement. We were very particular about the patient angle.