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Process Validation

Speed up your Process Development & Validation Program

PharmaSys personnel are experienced in process development, scale up, process optimization and process validation.  As a full service compliance firm, PharmaSys can provide customers with strategies to ensure manufacturing processes are robust and the defined critical parameters are based on data driven scientific techniques such as Design of Experiments (DOE), Design for Manufacturing (DFM), and Quality by Design (QbD).  PharmaSys personnel understand the Chemistry, Manufacturing and Control (CMC) requirements for regulatory submissions and utilize that knowledge to develop the strategies to produce the required data.

As an extension to our process development service, PharmaSys can provide the expertise to develop your process validation strategy and manage execution of the validation process as required.  In addition, PharmaSys can utilize our personnel expertise to help troubleshoot problem areas in your manufacturing process.  We can perform and manage Failure Mode Effect Analysis (FEMA) events, risk assessments, root cause analysis, and data mining.

Whether you are scaling up a new manufacturing process, expanding your process into additional facilities or making changes to an existing process, our engineers have the technical skills, compliance knowledge, validation experience and leadership to get your process validated with the least amount of time and expense to you.

Why PharmaSys?


Comprehensive Process Knowledge

 

Extensive Regulatory Experience

 

Thorough Process Validation Skills

 

Exceptional Leadership Ability

Areas of Expertise
 

Blood fractionation

Sterilization processes (autoclave, e-beam, gama, EtO, dry heat)


Bioreactions & fermentation

 

Upstream/Downstream Purification (Chromatography, Centrifugation, Ultrafiltration)

 

Aseptic process simulations (Media Fills, etc.)

 

Aseptic fill-finish

 

Environmental monitoring

 

Annual product reviews

 

Bulk API chemical processes

 

Solid dosage processes

 

Ointments, creams, liquids