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Method Transfer

At QCL – Quality Compliance Laboratories Inc., we can transfer your existing method to our facility and vice versa. Transfer protocols (with acceptance criteria) can be written by the client, QCL subject experts, or a combination of both parties.

We will execute the transfer protocol and issue a transfer report. Method transfers can be simple or complex depending on the stage of drug development as well as test methods that are run simply for informational purposes only or well established and validated methods for marketed products.

A method transfer allows both parties to run the method without the duplication of any validation activities that have already been performed.

Types of Method Transfers:

  • Verification

Documented evidence that a previously validated method performs as intended under actual conditions of use.

  • Qualification

A method transfer conducted such that only the receiving laboratory performs testing.

  • Comparative

A method transfer conducted in which the test solutions are assayed by the transferring and receiving laboratories.
- Criteria for comparison is consistent with the acceptance criteria from the analytical method validation.

  • All types of transfers involve repeating
    specific performance characteristics from
    the method validation.
Method Validation, Verification, and Transfer

Analytical Expertise for the 21st Century - Specific, Accurate, and Reproducible ...

In order to provide cost-effective solutions to our clients we initially examine the validation parameters at the development stage to ensure that the method is scientifically sound and delivers the required results. QCL’s method validation service establishes that the performance characteristics of an analytical method are suitable for the intended purpose.

Validations are performed under GMP environment. Unless otherwise required by our clients, we formally validate our methods as per ICH guidelines (International Conference on Harmonization), which includes; Accuracy, Precision, Specificity/Selectivity, Limit of detection, Limit of Quantitation, Linearity, Range, and robustness. As requested during the development and validation of stability indicating methods, we can perform forced degradation studies on your drug substance or drug product to provide stability validation of the analytical procedures. Routine forced degradation is carried through the application of using acid, base, peroxide, heat, and light.

Protocols employed for validation can be provided by our client or written by QCL experienced technical staff using our in-house method validation templates. Upon completion, detailed procedure and results for all method development and method validation projects are presented in a comprehensive report.

In addition QCL - Quality Compliance Laboratories Inc. can transfer clients’ methods following ICH guidelines and/or client’s protocol in accordance with GMP quality standards.


Typical methods validated for quality control purposes include:

  • Assay for Active Pharmaceutical Ingredients (APIs)
  • Assay for Finished Products (FP)
  • Related Substances and Impurities
  • Residual Solvents
  • Dissolution
  • Stability Indicating assays
  • Forced Degradation studies
  • Cleaning Verification and Validation
  • Process Validation support
  • Microbial Procedures (suitability)

Elements of Validation:

Parameter

Definition

  • Accuracy

an assessment of the difference between the measured
value and the real value

  • Precision

a measure of the agreement for multiple measurements on the same sample

  • Specificity

the lowest amounts of analyte that can be detected / determined accurately, respectively

  • Limits of Detection and Quantitation

an assessment of the lowest amounts analyte that can be
detected/determined accurately, respectively

  • Linearity and Range

the proportionality of the measurement to the concentration
of the analyte within a specified range

  • Robustness

a check of the effect of deliberate small changes to the method on the results