Search results for " inspection"
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Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
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Automation Trend in Fill/Finish Reduces Contamination Risk
At a larger scale, automated inspection systems allow high throughput and lower the operator overheads.
“Clearly there is an associated investment in any technology, and servicing/maintenance requi…
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Understanding Validation and Technical Transfer, Part I
Following a series of inspections, FDA questioned the manufacturers’ ability to ensure sterility of these products, leading to the promulgation of GMP regulations for LVPs in 1976 (3). Although the LV…
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Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
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Real Time Continuous Microbiological Monitoring
The results are obtained after enough days of incubation allow the development of colonies to be counted by visual inspection. The results are then expressed as colony forming units (CFU) per unit of …
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
However, upon further inspection, an animal component might be involved as part of the manufacturing process. The E. coli cultures may have been fed with culture media containing animal-sourced materi…
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Design and Qualification of Single-Use Systems
Equipment Design Regulations and Guidance
While drug and vaccine manufacturers are subject to regulatory review and inspection of how equipment is used, that is not the case for the manufacturers …
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …