Search results for " CGMP"
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Gowning Practices Provide Clues to cGMP Compliance
FDA explains the idea of “current” as follows:
…the “c” in cGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulation…
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Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing?
Smith (Catalent): In general, it is not difficult t…
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Regulatory Challenges in the QbD Paradigm
THE DESIRED STATE FOR REGULATORY AND PHARMACEUTICAL INNOVATION
In 2002, FDA launched Pharmaceutical CGMP for the 21st Century–A Risk-Based Approach , an initiative to encourage the adoption of m…
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Bioburden Control in the Biopharmaceutical Industry
Regulatory bodies stress the necessity of adhering to cGMP requirements for facilities manufacturing biologic products to ensure quality in both the process and product (4).
There are several f…
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Managing Risk in Raw Material Sourcing
Data transparency now the norm
Pharmaceutical manufacturers are demanding not only cGMP compliance, documentation support, and close management of critical changes, but increased information trans…
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Successfully Moving Regulated Data to the Cloud
FDA, Data Integrity and Compliance with Drug CGMP–Questions and Answers Guidance for Industry (CDER, December 2018).
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A Plastic Pipeline for Commercial Bioprocessing?
“Single-use bioreactors, currently available in sizes up to 2000–4000 L, are a potential solution when looking for smaller vessel capacities,” says Joe Prado, director, cGMP biomanufacturing operation…
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Applying GMPs in Stages of Development
Applying the correct level of cGMPs to the product development stage is really a matter of common sense. The earlier the product phase is, the more flexible your requirements. As the product approache…
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Best Practices in Qualification of Single-Use Systems
When end users actually implement SUS in cGMP biomanufacturing processes, however, there are still many challenges including the following:
• Lack of thorough understanding of new materials (e.g.,…
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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