Search results for " quality assurance" in Articles / App Notes
Article
Regulatory Challenges in the QbD Paradigm
The inspection team would review documents that present and justify the control and optimization of such important aspects of product quality assurance.
The emphasis of inspection would be on i…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Foster individual commitment and collaboration
No one functional unit can assure high quality and compliance, not even the quality assurance department. Instead, it must be a collaborative effort …
Article
Quality by design for biotechnology products—part 1
Guidance for industry: PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004 Sept.
5. Lonesberg N. Human antibodies from transgenic animals. Nature …
Article
Operational Excellence: More Than Just Process Improvement
…; increasing collaboration and partnership between operations and quality; and creating a continuing quality assurance (QA) presence on the shop floor. The absence of a QA presence coupled with the p…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
QbD and PAT in Upstream and Downstream Processing
This, of course, involves specialists from R&D, manufacturing, and quality assurance. The design qualification and review is challenging the equipment design with special attention on CQAs such as con…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
FDA Seeks Metrics to Define Drug Quality
12, 2013
Federal Register notice (1), FDA solicited such information, and manufacturers and industry trade associations submitted comments describing a variety of industry standards and quality as…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…