Search results for "quality" in Articles / App Notes
Article
Setting Standards for Biotech Therapeutics in India
India has emerged as a key supplier of high quality and affordable medicines not only to the developing world, but also to developed economies as well (Figure 1A) (1). This sector has recorded a compo…
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EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Before an analytical method can be incorporated into a characterization platform or a quality control system, it must first demonstrate that the method is suitable for its intended purpose. Guidelines…
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Remote Monitoring and Big Data Advance Upstream Automation
“Connected, continuous, and process analytical technology (PAT) solutions that bring more process intelligence and quality decisions to the factory floor are becoming more common,” asserts Marc Sincla…
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Applying GMPs in Stages of Development
I work in the quality and regulatory departments of a contract manufacturer. We have clients with products in various stages of development that are using multiple contracts with multiple services pro…
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Best Practices for Data Integrity
If manufacturing data are missing or inaccurate, then the firm is in violation of GMP regulations; it may mean that the quality of the product cannot be trusted. In serious cases, bad data integrity c…
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Breakthrough Drugs Raise Development and Production Challenges
…lopment timeframe involved raises numerous difficulties for manufacturers seeking to ensure product quality and timely supply. Expert review teams in the Center for Drug Evaluation and Research (CDER…
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USP Publishes Monoclonal Antibody Guidelines
…pidly expanded in healthcare, raising questions and presenting crucial issues associated with their quality and efficacy. Unlike small-molecule medicines, which have more easily defined quality attri…
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Challenges and Trends in Biopharma Facility Design
…ytiva): Biopharma-ceutical companies have to carefully consider parameters such as facility design, quality, time and cost for construction, and regulatory requirements. The quality of the facility i…
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Applying GMPs to the BioPharma Supply Chain
Suppliers share a commensurate responsibility, as the quality of raw materials has a direct impact on these goals. There is an acknowledged gap between current capabilities of many suppliers and what …