Search results for "quality"
Article
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…
Article
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…
Article
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 …
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Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
Impact of Shifting Risk
With the ACA’s endorsement of ACOs, there is a clear emphasis on shifting risk associated with the quality and costs of healthcare to the provider. The focus on the ACO mod…
Article
Best Practices in Adopting Single-Use Systems
Numerous technical advances have contributed to the attractiveness of single-use equipment across the range of production scales, such as improvements in materials and quality of construction a…
Article
PDA's Technical Report for Biotech Cleaning Validation
LeBlanc
ABSTRACT
Quality by Design principles such as design space can also be applied to cleaning validation. As discussed in the recently published PDA Technical Report No. 49: Points to Consi…