Search results for " regulatory"
Article
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…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…