Search results for " compliance" in Articles / App Notes
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
You might have certain manufacturing people on site, maybe some quality operations people, but the compliance people and others that would normally be on site to be part of that investigation might be…
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A Look into the Future of Biopharmaceutical Quality
…rward, BioPharm International spoke with Anthony Newcombe, principal consultant, Strategic Compliance, with PAREXEL and Susan Schniepp, executive vice-president of Post-Approval Pharma and distinguis…
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Bioburden Control in the Biopharmaceutical Industry
Bioburden contamination is affected by the degree of compliance to GXP rules. According to FDA’s definition, an “adulterated” pharmaceutical product is one which is manufactured under non-cGMP conditi…
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Managing Risk in Raw Material Sourcing
Data transparency now the norm
Pharmaceutical manufacturers are demanding not only cGMP compliance, documentation support, and close management of critical changes, but increased information trans…
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USP Stresses Pharmacopeial Standards at CPhI China
Topics included global harmonization with industry standards and regulations, compliance monitoring, and accountability. The USP requirements for elemental impurities, FDA’s metrics program, and the g…
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A Look Ahead at BioPharma Manufacturing and Regulation
BioPharm: Regarding imports, FDASIA notes that foreign manufacturers must demonstrate the regulatory status of their drug as well as cGMP compliance and prove facility registration within the US; othe…
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Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
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Top Process Development Trends for 2021 and a Look into 2022
Implementing Titers, Compliance, Mechanistic Modeling of Chromatography for Smarter Process Development
Bioprocessing has evolved over the past 30 years, and readers how curious how to navigate the…
Article
A Stepwise Approach to a Digital Transformation in Biopharma
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An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…
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Setting Up Bioprocessing Systems for Digital Transformation
Bob Lenich, director of global life sciences at Emerson, says that manufacturers are well aware they will be audited, and thus recognize the need to have strict compliance in place. The challenge here…