Process Validation Capabilities

At Kymanox, our team of process validation experts can help meet your specific needs with fit-for-purpose solutions.
01

Process Validation Lifecycle

We look at process validation as a lifecycle and follow FDA guidance which presents process validation in 3 phases: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification.
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02

Depth of Expertise

Our broad experience ensures analytical methods are validated to support process development and control. Our qualification experience extends to equipment, facilities, and utilities also.
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03

Integrated Team Approach

Keeping all aspects of process validation on track requires a combination of engineering, project management, and regulatory expertise. Kymanox excels in these cross-functional projects.
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04

Regulatory Focus

Kymanox stays up to date with the regulations issued by governmental agencies and industry guidance issued by both governmental and non-governmental bodies (e.g., ISPE, ISO, ICH, WHO).
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Meet our Process Validation Solution Experts 

Nicole Bridgers
ASSOCIATE DIRECTOR PROCESS ENGINEERING

Markets That Benefit from Our Process Validation Solutions

Combination Products

Turnkey Solutions Bringing Your Combo Product From Concept to Commercialization

Biologics

Turnkey Solutions Bringing Your Product From Concept to Commercialization

Pharmaceuticals

Turnkey Solutions Bringing Your Product From Concept to Commercialization

Other

Turnkey Solutions Bringing Your Product From Concept to Commercialization

The Kymanox Difference

At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.
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"Right First Time” Execution

Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
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Proven Broad Expertise

Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.
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Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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Frequently Asked Process Validation Questions (FAQs)

Why is a control scheme necessary?
A well-defined control scheme must be developed to ensure the process consistently produces quality product(s).  The process must be well-characterized to assist with developing an appropriate sampling plan that produces data that is statistically significant during PPQ. 
Does Kymanox follow GAMP guidance?
Whether the focus is on implementing automation into already functioning systems, or purchasing new equipment or systems utilizing automation, Kymanox leverages the Good Automated Manufacturing Practices (GAMP) guidance approach which defines a set of industry best practices to enable compliance to all current regulatory expectations, leveraging your company’s current quality procedures. For this reason, it can be tailored to a number of computer system types without significant impact to current equipment and systems.  We work in concert with users and suppliers so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance, known as User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), that a system is appropriate for the intended use before it goes “live.” We can also ensure that suppliers use GAMP methodologies to test for avoidable defects in the supplied system to ensure quality product leaves the facility.   For example, ISPE’s GAMP V-model is fully leveraged and all validations are based on approved, testable requirements.