Search results for "regulatory"
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Cleaning of Dedicated Equipment: Why Validation is Needed
The quality of an API is intrinsically related to the cleaning procedure employed; therefore, this aspect needs to be adequately addressed by the manufacturers and deeply reviewed by regulatory author…
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Taking a “Development-by-Design” Approach to Cell Therapies
Regulatory agencies understand that it is difficult to pinpoint MOA.”
Preti emphasizes the importance of working with regulators. “You can be in a position to inform and influence regulations as p…
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A Bright Future for the Plasma Fractionation Industry
Among the quality and regulatory trends, Quality-by-Design (QbD) remains to be a popular topic. Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Pro…
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Modern Manufacturing Systems Key to FDA Quality Initiative
OPPQ further coordinates FDA quality-related policies with other regulatory authorities and with independent standards-setting organizations.
This approach will be supported by a new quality metri…
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USP Publishes Monoclonal Antibody Guidelines
Applicable requirements for those are determined by the appropriate regulatory agency.
USP reference standard
Accompanying the new general chapter is a recently-developed reference standard (RS…
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FDA Approves First Biosimilar
The decision by the regulatory body comes five years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), part of the Affordable Care Act that was signed into law i…
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Ligand-Binding Assays and the Determination of Biosimilarity
He adds that regulatory authorities recommend simple and reliable methods for the characterization of biosimilars, and LBAs are one type of alternative.
For drug substance/drug product testing, on…
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Continued Process Verification for Biopharma Manufacturing
Of course, having and following a CPV plan should also put the manufacturer in more favorable standing with GMP regulatory inspectors.
One of the main struggles to resolve when implementing CPV wi…
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Evaluating Design Margin, Edge of Failure and Process
Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulat…
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EMA Invites Comments on New Guidance for Vaccine Development
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulatory, quality, non-clinical and clinical aspects of the development of all…