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| | Process Validation is the most critical part of the
entire validation program. Yet, most validation contractors do not offer
competent process validation services. Not so at Gavin Pharmaceutical Services.
Led by a president with years of industry experience across the spectrum of
pharmaceutical dosage forms, this unusual validation contractor brings
excellence in process validation services to your door.
Key Areas of Expertise
- Process Evaluation
- Process Validation Planning
- Process Validation Design and Execution
Capabilities
Process Validation is as complex as the process. In the world
of pharmaceutical manufacturing, that can mean highly complex. Biotechnology
adds another dimension of difficulty, often due to the uncharted waters of
therapeutic innovation. We will evaluate the stage of process development and
determine the simplest approach for your consideration.
We are experienced in experimental design for process
optimization, an extensive approach which results in
extremely rugged process results. We will develop process
capability studies, determine the critical
parameters for the process, and either execute or assist
you in execution of the appropriate testing.
- Process Evaluation
- If this is your first experience with process
validation, we will assist you in Process Evaluation. This may include
an evaluation of the process ruggedness and repeatability.
Ruggedness refers to the ability of a process to withstand
challenge from variation in raw material characteristics, process
parameter variation, equipment selection, and operator technique. Repeatability
refers to the capability of the total process to maintain key quality
attributes, batch after batch. Further, it is critical to evaluate the
process equipment capability, including the results of process limits
tests run during equipment qualification tests. The evaluation results
will be used in the planning, design, and execution.
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- Process Validation Planning
- We will advise you regarding the required analytical
technology and the assay validation which must be in place before the
study begins. If your laboratory is unable to provide the necessary
support, we have relationships with contract laboratories which can do
that for you.
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- Process Validation Design and Execution
- We write process validation protocols to formalize
the study design. We will oversee sample collection, evaluate results,
and put it all together. We can provide sophisticated statistical
analysis if required, as well.
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![[Gavin Pharmaceutical Services]](images/logo.gif){kind=logo}
"Excellence in Service" 
