Search results for " guidance"
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Quality Systems Key to Lifecycle Drug Management
FDA issued a guidance in March 2014 that sought to expand the range of manufacturing changes that can be documented in annual reports, but the list was fairly limited, and industry has found it incons…
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Labeling of Biosimilars
In December 2014, guidelines on quality standards for biosimilars with proteins as an active substance came into effect (1), while guidance on clinical and non-clinical issues with the products was be…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2012, the EMA also published final guidance, the non-clinical and clinical requirements for biosimilar mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficac…
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Updating Viral Clearance for New Biologic Modalities
Guidance is needed
Compounding all these challenges is the fact that published regulatory guidances have been based on traditional biologics, such as mAbs and related Protein A binders, says Berri…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Biosimilars and the impact of FDA guidance
BioPharm: Regarding biosimilars, there have been some changes in the US, with FDA setting requirements for analytics and for interchangeability…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Regulatory guidance documents (9–11) suggest that the risk of adventitious agent contamination should be assessed and mitigated through a tripod strategy (Figure 1):
• Preventing entry of cont…
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Drug Quality Key to Innovation and Access
Under the new draft guidance, the program will be voluntary for a year and request three, instead of four, data elements, starting with lot acceptance rate, product quality complaint rate, and invalid…
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Establishing Acceptance Criteria for Analytical Methods
This logic is essentially laid out in two guidance documents: International Council for Harmonization (ICH) Q6B Specifications and ICH Q9 Quality Risk Management (2).
Clearly defined method accept…
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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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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…