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PHARMACEUTICAL INDUSTRY :
GMP Laboratory Readiness |
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Client: |
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A
start up pharmaceutical company with a product on the FDA "fast track."
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Problem: |
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The
client recognized that its quality control laboratory would not meet
GMP criteria based on internal and external audits. It was critical
that the QC lab be operating in a GMP manner, in a brief timeframe,
to meet company goals for filing of their first drug product. |
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Approach: |
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Tunnell Consulting
was asked to work with the QC Lab which included supervisors and scientists
to create and implement a plan that would result in the QC lab meeting
GMP compliance. Tunnell supplied subject matter expertise, project
management support, and team facilitation. Critical metrics were identified
which included:
Equipment qualification
Test method validation
Essential laboratory SOPs
Training
Existing data was collected against all metrics. Functional key
stakeholders were involved throughout the project, providing critical
information, data, and the identification of problems and functional
gaps that had to be addressed.
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Results: |
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Tunnell
Consulting entered into an ongoing long-term partnership with the
client, already lasting several years, and was ultimately selected
as the client's sole supplier of outsourced analytical and validations
services. We provided the following:
TC assigned high-caliber, experienced scientists to develop and
validate methods, address routine testing requirements, and relieve
backlogs
TC scientists became qualified on client SOPs, lab protocols,
data formats, data systems, policies and procedures
TC scientists organized, planned, and supervised work teams of
analytical chemists, working at client facilities and on client
equipment, consistent with cGMP standards
TC scientists performed analytical testing across multiple consumer
products and dosage forms
TC project managers organized data, developed reports, and facilitated
the report review and approval process
TC provided expert resources to support both routine R&D laboratory
testing and clinical/regulatory submissions
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