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Transdermal Formulation Analytical Method Transfer

Inquiry

Analytical method transfer is a process required by GMP. It is an important link to ensure consistent, reliable, and accurate test results between different laboratories. It is also an important assessment of laboratory testing capabilities. CD formulation can provide the method transfer process based on ICH guidelines and using the latest technology.

About Transdermal Formulation Analytical Method Transfer

Analytical method transfer is a recorded process that qualifies the receiving laboratory to use the analytical method originated from the transferring laboratory. This process may involve steps such as adaptation, validation, and training. The main purpose is to ensure that the original analytical method can remain accurate and reliable in the new environment and meet new analytical needs.

What Can We Offer

Method development

According to the drug development needs of customers, we provide customized analytical method development services to ensure the accuracy and reliability of the methods.

Method validation

Strict validation of the developed methods, including the evaluation of accuracy, precision, specificity, and other indicators, to ensure that the methods meet production requirements.

Method transfer

Transfer the validated methods from the R&D stage to the production stage, including technology transfer, personnel training, equipment debugging, and other links to ensure the stability and consistency of the production process.

Our Workflow for Transdermal Formulation Analytical Method Transfer

Fig.1 Workflow of transdermal formulation analytical method transfer. Fig.1 Flow chart of transdermal formulation analytical method transfer. (CD Formulation)

Method Selection and Review: Clearly define the objectives of the method transfer, such as for regulatory submission or routine testing.
Transfer Plan Development: Develop a realistic timeline that includes milestones for the completion of each stage.
Pre-Transfer Assessment: Ensure that the receiving laboratory is adequately equipped and capable of performing the method.
Method Transfer Execution: Conduct initial trials to evaluate the method's performance in the receiving laboratory. Make any necessary adjustments to the method or procedures to ensure consistency and accuracy.
Validation and Verification: Validate critical parameters, including precision, accuracy, specificity, and sensitivity. Analyze the results to verify compliance with the acceptance criteria defined in the protocol.

Our Technology Platform

Our method is based on ICH guidelines or USP, and there are several methods:

Technologies	Description
Comparative test	The most commonly used method for transferring analytical methods requires the recipient and the transferor to jointly conduct comparative tests on a predetermined number of samples from the same batch or multiple batches, and then compare the test results.
Joint verification by two or more laboratories	The analytical method must undergo methodological verification before transfer. To reduce the randomness of comparative test data and shorten the time for method transfer, we can use the method of joint verification by two laboratories to transfer the method.
Revalidation of analytical methods	Refers to the receiving laboratory repeating part or all of the content of the methodological validation. If the validation process is successfully passed and meets the acceptance criteria, it proves that the laboratory can operate the analytical method, that is, the analytical method is successfully transferred.
Exemption from testing	It is a method of transferring analytical methods without requiring or reducing comparative test items. The receiving laboratory can directly use this method for formal testing, but the premise is to ensure that this method is effective and reliable and must be recorded and explain the reasons.

Why Choose Us for Transdermal Formulation Analytical Method Transfer?

We have extensive experience in the method transfer process for APIs and other sample types.
We have professional technical proposals and can generate compliance protocols based on ICH guidelines.
We have professional procedures and equipment and have completed method transfer for a variety of drugs.

Published Data

Technology: Methods to Analytical Method Transfer

Journal: Journal of pharmaceutical and biomedical analysis

IF: 3.571

Published: 2010

Results: The appropriate organization of analytical method transfer is an essential part of the quality assurance system, when pharmaceuticals are produced and analyzed at different sites. In previous works, it was already shown that during method transfers, testing for equivalence is more appropriate than the classic two-sample t-test.

CD Formulation can provide you with expert analytical method transfer. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.

References

L. Kaminski, U. Schepers. Identification, Analytical method transfer using equivalence tests with reasonable acceptance criteria and appropriate effort: Extension of the ISPE concept. Journal of Pharmaceutical and Biomedical Analysis. 2010. Volume 53, Issue 5.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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