Process Validation Capabilities
At Kymanox, our team of process validation experts can help meet your specific needs with fit-for-purpose solutions.
Process Validation Life Cycle
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.Start Getting More Done!
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.Start Getting More Done!
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.Start Getting More Done!
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).Start Getting More Done!
Meet our Process Validation Solution Experts
Markets That Benefit from Our Process Validation Solutions
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.
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.
"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
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.
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.
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.
Read the Latest at Kymanox
Kymanox Acquires EU Based Anteris Medical and Anteris Helvetia
Leveraging the well-respected anteris brand and team, this acquisition extends Kymanox’s capabilities and geographic reach with a strong European presence Friday, 03 February 2023 Morrisville, North Carolina, USA and Holzkirchen, Germany an...
Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen
Kymanox Executive Advisors (KEAs) Mathias Romacker, Fran DeGrazio, and Paul Jansen sit down with Guy Furness to discuss what has driven Kymanox's rapid rise in the drug delivery space and what makes the consulting company's model so successful, as well...
Growing Happy Cells: Bioreactor Optimization
Biologics, including cell and gene therapies, have become a hot topic in the pharmaceutical industry as their therapeutic applications expand. Challenges of developing biologic drug products include scale-up for commercial manufacturing and production ...