Process Qualification

Demonstrating that the Manufacturing Process yields the desired result.

Process Qualification, also referred to as Process Performance Qualification, combines all aspects of a manufacturing facility to confirm that the ‘manufacturing system’ can reliably produce acceptable commercial batches.  Process Qualification evaluates the Quality Attributes (CQAs) of your process’s output.  Within the life science industry common product Critical Quality Attributes are indications of strength, purity, and uniformity.  

The key to any successful Process Qualification is understanding your product attributes and the means by which they can be controlled.   Sequence’s perspective, combining the latest industry best practices, Quality and Compliance expertise,  and a methodology for delivering successful process validation results efficiently, is what makes us unique.  

 

Services

  • Project Management
  • Tech-Transfer
  • Quality controlling parameter determination (DOE, Multivariate analysis)
  • Evaluations / Studies
  • Process improvements (increased efficiency, productivity)
  • Raw material qualification
  • MBR Manual process development
  • Automated process development
  • Investigations
  • Validation Plan development
  • Efficient validation strategy determination (minimize release interruptions)
  • Process Validation test execution
  • Validation Summary development
  • Release Report Development
  • SOP Development

CUSTOMER COMMENTS

Customer comments

 “Sequence has been, withoua shadow of a doubt, the most customer-centered company with whom I have ever had the pleasure to work.”  – Director, LinkedIn

“Compliance and Data is critical to our business.  Sequence understands that the right data management solution must fit our business needs as well as our compliance strategy.” – Sr. Manager, LinkedIn

 Sequence took our vision and with the most amazing teamwork strategies I have ever witnessed turned it into a viable reality.” – Sr. Manager, LinkedIn

“Thank you for the amazing efforts of your most innovative and hardworking staff.” – VP, LinkedIn

How Can We Help You?

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855.844.7171 info@sequenceqcs.com

Global Headquarters:
  2100 Gateway Centre Blvd
  Suite 301
  Morrisville, NC 27560

Compliance Center:
  [Mailing Address]
  2500 Gateway Centre Blvd Suite 850
  Morrisville, NC 27560