cGMP Testing Services

Avanti is an FDA licensed manufacturing and testing facility. Our Analytical Services Division along with the support of our Quality Assurance Department can provide the testing you need under strict cGMP compliance. All cGMP services are quoted upon request. (The pricing listed in other areas of our Analytical Services website are to provide results that are for research use only.)

We can provide:

  • Method Design
  • Method Development
  • Method Qualification
  • Method Validation
  • Written Standard Operating Procedures
  • Fully Documented Sample Receipt/Storage
  • Lipid Raw Material Release Testing
  • Quality Assurance Review
  • Product Release Testing
  • Stability Testing

Our most popular cGMP Testing Services include:

cGMP Analytical Method Development, Qualification, and Validation

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We perform method design and development for a vast array of assays including NMR, HPLC-ELSD, LC-MS/MS and GC. The goal of method qualification is to demonstrate a method is fit for the intended use. In most instances this requires some demonstration of specificity, accuracy and linearity. As the life cycle of products develop and change we are capable of moving methods from method development through full validation. Method validation requires assessment of clearly defined and agreed upon criteria utilizing a set of assays that demonstrate a robust reproducible method. A protocol is initiated and approved prior to the beginning of validation. The protocol includes experimental design as well as acceptable limits for method performance. The experiments routinely performed in validation include: system suitability, linearity, limit of detection, limit of quantitation, specificity, accuracy, precision (repeatability, reproducibility and intermediate), and robustness (CFR 211.194(a)(2)). We recognize that as the product lifecycle moves forward, and technology constantly changes, validated methods undergo a lifecycle of their own which includes continued method evaluation.

cGMP Stability Testing of Lipid Related Products

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Avanti can perform stability testing of lipid-related products or raw materials utilizing a combination of any of our assays. Development of a testing protocol based on ICH Stability Testing Guidelines is available. Samples are sent to Avanti on a pre-determined schedule for analysis. Results are reported back to you upon completion of testing at each time point. Following an initial consultation, we will provide a quotation for stability testing services.

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Please note that all of Avanti Analytical Services are performed in a Quality Control Laboratory by a trained analyst and is intended for research use only. All work is documented and reviewed by a second trained analyst but does not involve the review of the cGMP Quality Unit of Avanti. If you require cGMP analysis of a sample, please see our cGMP Testing Services page for more information.