How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines

Why Should You Attend:

Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated.

It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the project. Attend this webinar to understand the ICH and USP guidance for validation, and how to apply ICH guidelines for method transfer and how to establish boundaries.

Areas Covered in the Webinar:

• ICH guidelines for validation.
• USP guidelines for validation and verification.
• Applications of the ICH guidelines for method transfer.
• Debated topics and approaches.
• Complex procedures.
• Establishing boundaries.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• QC functions in general
• QC technical transfer groups
• QC validation groups
• Commercial testing facilities
• Product development
• Commercial project support

Barbara Berglund
COO, CMC Turnkey Solutions

Barbara Berglund, has been working in the pharmaceutical and medical device industry, specifically with sterile parenteral dugs, for over 15 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she currently manages is directly responsible for testing of products used in support of the medical device industry; she previously managed a QC team responsible for procedure transfer and validation in support of parenteral pharmaceutical products. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

Topic Background:

Analytical procedures are typically developed early in the clinical trial phases of drug development. The procedures may measure content, characters, or known impurities at this phase. During the movement of the trials toward commercial product status, formulations change, concentrations change, and presentations change. For many reasons, including the cost of method development, the procedures are not updated or changed as the phase of the product goes forward. Also, the knowledge management piece is not always accessible.

By the time a procedure is transferred to a receiving lab for routine testing of a commercial product, it is not uncommon for the original procedure to be validated for forward use. In some cases, this is perfectly acceptable. In other cases, there have been enough changes to the formulation, concentration, or presentation that the original procedure has lost some ruggedness. In addition, there may be attributes of the formulation which have become masked during the development of the drug. It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at this stage, rather than during routine manufacture, will improve the overall success of the project.

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