Search results for " guidance" in Articles / App Notes
Article
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…
Article
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Under the new draft guidance, the program will be voluntary for a year and request three, instead of four, data elements, starting with lot acceptance rate, product quality complaint rate,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Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
REGULATORY EXPECTATIONS FOR THE ANALYSIS OF MABS
Several guidance documents have been issued by regulatory agencies recommending approaches for protein characterization.3,4 Although guidance docum…
Article
ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…