Search results for " review"
Article
Avoiding Investigational Failures and Discrepancies
In this risk-based issue review phase an incident can be corrected or mitigated and closed, or a CAPA can be initiated, depending on what was discovered during the review. Each issue must be assessed …
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
If the process involves emerging manufacturing technologies, approval may be delayed as the regulatory authority representatives learn about the new systems during review of the chemistry, manufacturi…
Article
Continuous Processing for the Production of Biopharmaceuticals
This article aims to review the efforts to make various unit operations continuous as well as the integration of these operations to make a truly continuous process.
Throughout the evolution of ma…
Article
Antibody Production in Microbial Hosts
In this article, the authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
Fi…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
The guidance states that the ETT will “facilitate regulatory review of new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and Agency policy related to q…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Use and cost of misidentified and contaminated cell lines
How widespread is the problem? One key review examined the prevalence of contaminated cell lines from 1968 to 2007 and reported combined c…
Article
Best Practices in Qualification of Single-Use Systems
During the visit, the technical team members from both companies should review test designs, confirm test methods/results, review test reports, and understand the test results. When needed, sub-suppli…
Article
Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
Article
Gowning Practices Provide Clues to cGMP Compliance
A review of a facility’s gowning operations can bring significant insight into the current state of cGMP compliance.
Gowning embodies many of the major elements of cGMPs and as such is a window in…
Article
FDA Seeks Metrics to Define Drug Quality
To further encourage quality production, FDA seeks to establish clear, written, clinically relevant public standards that it can enforce through review and inspections. This effort is supported by the…