Tag: <span>quality by design</span>

Using Product Lifecycle, Process Validation, and Quality by Design (QbD) Paradigms to Efficiently Take New Biopharmaceutical Products from Pre-IND to Commercial Manufacturing

This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program…

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Biologics Biologics Production Manufacturing Quality Risk Management (QRM) Regulatory

development pipeline ichq8 product lifecycle qbd quality by design

Using Lifecycle and Quality by Design (QbD) Approaches to Define, Plan, and Execute Biopharmaceutical Projects

The world in general, and biopharmaceuticals in particular, are becoming increasingly complex and challenging. The ability to plan and execute a project to efficiently and effectively achieve a high-quality project goal is especially important for developing and manufacturing biopharmaceutical products. Managing projects ranging from product development, process characterization and validation, to building new manufacturing facilities requires straightforward, effective project management approaches and tools. But perhaps even more importantly, managing a project is a fundamental enabling skill required to manage both oneself as well as teams of people.

Read MoreUsing Lifecycle and Quality by Design (QbD) Approaches to Define, Plan, and Execute Biopharmaceutical Projects

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biologics enterprise biopharmaceuticals product lifecycle project lifecycle qbd quality by design sme subject matter enterprise

ICH Q12 Should Build on the ICH Q8 Design Space

The current draft of ICH Q12 appears to have taken several steps backward in the pursuit of the manufacturing excellence initiated by ICH Q8 (R2) pharmaceutical development and expanded by FDA’s 2011 process validation guidelines…

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Manufacturing Regulatory

process control quality by design

Integrating Development Tools into the Process Validation Lifecycle to Achieve Six Sigma Pharmaceutical Quality

Achieving very high levels of pharmaceutical product quality, particularly for the next generation of biologics, will require proactive use of a broad range of quality and process development tools throughout the therapeutic’s development and manufacturing lifecycle. These tools are most effective when integrated using an expanded form of FDA’s 2011 process validation guidelines. This article explains how process validation can be combined with quality by design (QbD), ICH Q8 design space (DS) and control strategies (CS), process analytical technology (PAT), and quality risk management (QRM) tools to provide a path to manufacturing very high-quality products. The approach establishes clear goals and then proactively builds appropriate control systems during process development to assure continuous control and verification of all manufacturing activities. Prospectively using the tools over the complete manufacturing lifecycle, from preclinical through commercial manufacturing, is particularly important to assure comparability from early product research and development all the way to commercialization. The continued evolution of these quality tools, as well as building new tools, will provide a path for the pharmaceutical industry to reach and maintain Six Sigma levels of product quality…

Read MoreIntegrating Development Tools into the Process Validation Lifecycle to Achieve Six Sigma Pharmaceutical Quality

Manufacturing Risk Analysis and Management

commercialization process analytical technology process control process validation quality by design six sigma