Activities

Support QA Activities

September 5, 2022

GMP Consultants are engaged with clients on long term basis from several hours / week to multiple days / week to assist teams with the following tasks (to name a few);

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Reduce Quality System Backlogs

June 5, 2022

GMP Consultants have supported many large and small Pharmaceutical companies to reduce their Deviation, Change Control, and CAPA backlogs. We also provide training on Deviation Processes and Human Error Reductions to help reduce the number of deviations initiated.

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Implementation of GMPs for New Clinical Manufacturing Area

September 1, 2021

A team of GMP Consultants were mandated to set up and manage GMP processes (Deviation, CAPA, Change Control, Batch Record), procedures and training for the new clinical manufacturing areas for high quality proteins and biomolecules at a biotech company. Validation…

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Manage FDA Warning Letter Commitments and Oversee Technology Transfer

September 10, 2020

In 2019-2020, GMP Consultants was selected to assist a team of experts in Pontoise, FRANCE to implement remediation actions in response to a FDA Warning Letter given to a leading cosmetic company. After 3 months, GMP Consultants was solicited to…

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