Search results for " inspection"
Article
Aseptic Processing: Keeping it Safe
Negative agency inspection, increasing operating costs, and poor media fill results are among the reasons many manufacturing organizations are deciding to update or replace aging aseptic processing eq…
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New Era for Generic Drugs
The program expands FDA review staff, supports timely field inspections, and funds research on developing more complex generic dosage forms. One result is the elevation of the relatively small Office …
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Raw Material Variability
Common examples would be out of specification for a product critical quality attribute (CQA), slower cell growth, low titer, and evidence of extraneous matter following visual inspection.
Fixing…
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Manufacturers Struggle with Breakthrough Drug Development
Early submission of CMC information will allow for timely review and for FDA to determine if the potential manufacturing site will require inspection, especially when contract manufacturers are involv…
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Supplier-Change Management for Drug-Product Manufacturers
…-purchaser relationship, for example:
• Right to audit
• Responsibilities for regulatory inspections, filings, and communication
• Management of documentation and records
• Timing and…
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State of Quality and Compliance in the Biopharmaceutical Industry
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning letters, and consent decrees resulting from facility inspections. Th…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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The Lifecycle Change of Process Validation and Analytical Testing
Assurance of process control can be obtained by observation, inspection, or evaluation of process parameters and product attributes. Where complete observation is not possible, companies need to predi…
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PDA's Technical Report for Biotech Cleaning Validation
In contrast, nonspecific analytical methods (such as TOC, Bradford, conductivity, and visual inspection) measure a general property, such as conductivity or TOC, which could result from various analyt…