Quality Control Capabilities
The Kymanox Quality Control (QC) team provides knowledge and expertise to ensure that QC processes and methods support a risk-based, Quality by Design (QbD) approach.
01
Gap Assessments
Kymanox offers PAI readiness and Annex 1 gap assessments to ensure you’re aligned with regulatory guidelines and expectations. Our clients have a perfect track record when they address gaps identified in our assessment.
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02
Microbiology, EM & PM Project Controls
Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) services include Contamination Control Strategy, Disinfectant Efficacy Testing, Environmental Monitoring Performance Qualification (EMPQ), Bioburden, Endotoxin, and more.
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03
Other Areas of Expertise
Out Of Specification (OOS) Investigation, Laboratory Equipment Qualification, Method Transfer/Validation, Phase Appropriate Standard Operating Procedures (SOPs), Elemental Impurities Assessment, and Raw Material Qualification
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04
Full Range of Services
Kymanox holds a 360° view of all quality monitoring services and supports these services with additional capabilities such as Quality Assurance, Auditing, CMC, Analytical Sciences, Regulatory Affairs, and more.
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Meet our Quality Control Experts
Jaime Rain, MMB
DIRECTOR, QUALITY CONTROL
Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Quality Control Solutions
Combination Products
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.
The Kymanox Quality Control Difference
We ensure your Quality Control needs are not only right for your company but also aligned with regulatory expectations by blending our hands-on, practical quality control experience with other functional capabilities.
"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.
What Our Clients Have To Say About Kymanox
Frequently Asked Quality Control Questions (FAQs)
Is heavy metals testing still a requirement for Drug Product?
No. Heavy Metals testing has been replaced with USP <232> and <233> Elemental Impurities and ICH Q3D Elemental Impurities. Companies must comply with ICH Q3D and assess elemental impurities to develop risk mitigation for those elements that do not provide a therapeutic benefit. An Elemental Impurities Risk Assessment can be used to evaluate all potential sources of elemental impurities and their contribution to drug product. Learn more at Elemental Impurities | FDA
How is the reliability of raw materials used in cGMP manufacturing best achieved?
It is critical to control the raw materials used in the manufacturing process by qualifying the suppliers of the raw materials. Without qualification, assurance in the safety, quality, identity, purity, and potency of the final product can be impacted. However, it is often not necessary to perform full Certificate of Analysis testing for every raw material upon receipt. A risk assessment can be used to evaluate the required grade/purity of the material, the criticality of the raw material to the process, the applicable compendia, etc. to determine the appropriate level of raw material testing upon receipt as well as the frequency of requalification.
Are in-use stability studies required for non-preserved products?
There is a regulatory expectation for non-preserved products that will be prepared, stored and punctured multiple times following release of the product to the clinic or hospital have an in-use stability study to support the use and storage of the product over a defined amount of time. In-use stability studies provide supporting data on the impact of sample manipulation, multiple punctures, storage temperatures, and duration of use for the product.
What gap assessments are involved with Pre-Approval Inspections (PAIs)?
PAI readiness gap assessments include a review of and support with: Vendor, Raw Material, and Component Qualification; Stability Program Plans, Protocols, and Reports; QC Method Development, Qualification, and Validation protocols and reports ; and Elemental Impurities Risk Assessment.
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