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Method Transfer In The Pharmaceutical Industry

Method Transfer In The Pharmaceutical Industry

Method transfer in the pharmaceutical industry is a crucial element of the quality control aspect of the drug development process. It serves as a kind of fail-safe to ensure that the methods being performed in one laboratory produce reliable results when duplicating the procedure in another.

Boston Analytical has the equipment, expertise, and capabilities necessary to provide analytical method transfer for pharma and biotech companies under virtually any conditions. With our guidance and rigid adherence to the most stringent standards found anywhere in the industry, we are dedicated to providing the highest levels of service.

Ensuring proper analytical method transfer in pharma is crucial for several reasons. First and foremost, this process provides assurance that your lab’s work is being conducted in the most successful and accurate manner possible. Method transfer also ensures that your processes match with industry standards, especially GMP. Finally, method transfer and validation are critical to make sure your company produces pharmaceuticals that are safe for the public and effective in their stated purpose.

How Does Method Transfer Take Place?

Following analytical method transfer guidelines is extremely important in order to receive the best results from the procedure. In a general sense, it requires your laboratory (also known as the sending laboratory) to provide extensive documentation of an analytical test procedure to another facility (known as the receiving laboratory). Using the documents provided, the receiving lab should be able to duplicate the testing procedure down to the smallest detail. After running the duplicated test, the receiving lab should be able to confirm that it produces the same results. The receiving lab might then flag any issues with the methodology or any other elements of the test for further clarification and send the results back to the sending laboratory.

At the core of the entire process are the documents that detail all the pertinent aspects of the test in question. These documents should include specifications such as desired atmospheric conditions, sample preparation approach, and equipment settings. After the entire method transfer is complete, the laboratories typically move into the validation phase.

The Different Forms of Transfers

Method transfers can take several forms, depending on the circumstances. Comparative testing, which involves the use of homogeneous lots of materials by both labs, is the most common type. However, the process can also take the form of:

  • Revalidation: If the sending laboratory cannot perform comparative testing for any reason, this option uses a risk-based approach to specify which parts of the test will be duplicated at the receiving laboratory.
  • Covalidation: This process involves multiple laboratories for GMP testing. The receiving lab is part of a team of labs that all perform various experiments.
  • Transfer Waver: If the receiving laboratory has already performed the same experiments on another product and can attest to their accuracy, or if the procedure is in the USP-NF, the transfer may be skipped and the results accepted as read.

Why Choose Boston Analytical?

For more than 30 years, Boston Analytical has been providing life science companies with the highest-quality analytical testing services. We work closely with our clients, offering them dedicated project managers who can help establish their goals and strategies. We deliver the most advanced technology, results-driven processes, and a wide range of specialty services that few others can provide. We are always looking for the next advancement that can help our clients achieve greater outcomes. Our cGMP-compliant, FDA/DEA-registered and ISO/IEC-17025:2005-certified laboratory is located just outside of Boston in Salem, N.H.

To learn more about everything we can do for your operations, get in touch with one of our representatives today.

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