Quality Control Solutions | Kymanox | Life Science Solutions Partner

Quality Control Capabilities

The Kymanox Intelligent Enterprise Team is an international provider of ERP Optimization, Implementation and Compliance solutions for life sciences. We offer a unique patient-centric, risk-based approach balanced with both regulatory requirements and business needs.

PAI Readiness Gap Assessments

Kymanox offers PAI readiness 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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Microbiology, EM & PM Project Controls

Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) services include Disinfectant Efficacy Testing, Environmental Monitoring Performance Qualification (EMPQ), Bioburden, Endotoxin, and more.

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Full Range of Services

Kymanox holds a 360° view of all quality monitoring services and support 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

ASSOCIATE DIRECTOR QUALITY CONTROL

Helpful Links

Here are some of our favorite resources on this topic

Elemental Impurities

On January 1, 2018, new guidelines regarding elemental impurities in brand and generic drug products went into effect.

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Markets That Benefit from Our Quality Control 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 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

“Kymanox has continuously stepped in to provide the expertise that we have needed exactly when we need it”

Director, Quality Control

Biotech Company

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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.