Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced contamination risks. However, the use of these components requires a thorough risk evaluation to determine their impact on the final product. Traditionally, manufacturers have used established risk assessment processes to evaluate these risks, including frameworks like the BioPhorum Operations Group (BPOG) to guide their assessments.
In this presentation, we will explore the principles and methodologies behind these risk assessment options. Attendees will gain insights into the current practices for evaluating the risks associated with single-use components in biopharmaceutical manufacturing. We will also discuss the draft sections USP 665 and 1665, which provide additional guidance and recommendations for testing, offering a more structured approach to the risk assessment process.
The session will delve into the specific steps involved in conducting a risk assessment for single-use components. Participants will learn how to identify potential risks, evaluate their impact on the final product, and implement appropriate testing protocols to ensure product safety and compliance. The presentation will also include real-life examples of risk assessments and their regulatory outcomes, providing practical insights into how these processes are applied in the industry.
By attending this webinar, professionals involved in biopharmaceutical manufacturing will acquire valuable knowledge on conducting effective risk assessments for disposable plastic components. This includes understanding the regulatory expectations and best practices for ensuring that these components do not adversely affect the quality and safety of the final product.
This presentation is essential for quality assurance, regulatory affairs, and manufacturing professionals in the biopharmaceutical industry. By gaining a deeper understanding of the risk assessment process and the latest guidelines, participants will be better equipped to manage the risks associated with single-use components and ensure their products meet the highest standards of safety and efficacy.