Search results for "regulatory"
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What's in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
By S…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
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Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS).
Equipment Design …
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Framing Biopharma Success in 2016
Encouraging companies to make capital improvements to avoid future quality and manufacturing problems, however, can be a tough financial and regulatory argument. In a 2015 survey of 100 executives fro…
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Biopharma Advances Demand Specialized Expertise
Regulatory and business trends
BioPharm: What regulatory changes have positively or negatively impacted biopharmaceutical development/manufacturing processes?
McNally (PPD Consulting): FDA estab…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical and biotechnology companies making products for human use have an obligation to ensure that their products are safe, effective, meet established regulatory expectations and licenses, an…
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State of Quality and Compliance in the Biopharmaceutical Industry
As a result of these efforts, new standards and guidelines have been published and numerous conferences held regarding quality systems, product quality, and regulatory compliance. However, after more …
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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…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
A broad range of alternative BioTx modalities have obtained regulatory approval and are currently in clinical trials (17–21) including antibody fragments, single-domain mAbs, Fc-fusions, vaccines, ant…
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Assessing Manufacturing Process Robustness
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzena Ingram, Robert Rhoades
The pharmaceutical regulatory landscape and pharmaceutical development have be…