Search results for " specification" in Articles / App Notes
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
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Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
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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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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Q&A with Industry Leaders: Rita Peters
This week, Process Development Forum's new Q&A feature interviews Rita Peters, Editor of BioPharm International Magazine, about second quarter trends in drug development.
Q: What trends have yo…
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Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to …
Article
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
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Drugs, At What Cost?
Generics, market dynamics, and global demand are changing drug spending patterns.
The underlying question for any drug in development is: What price can (or will) patients pay for the needed…