Search results for " pharmaceutical"
Article
Advancing QbD in the EU
In addition, EU authorities are becoming more concerned about the increasing number of quality defects in pharmaceutical manufacturing that have been causing a rise in drug scarcities.
ICH GUID…
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Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
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Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
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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…
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CoAs Help Secure the Supply Chain
The International Pharmaceutical Excipients Council defines a CoA as “a legal document that certifies the quality of the excipient and demonstrates the batch conforms to defined specifications, has be…
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Setting Standards for Biotech Therapeutics in India
35-40
The past decade has seen considerable growth in the Indian pharmaceutical industry. India has emerged as a key supplier of high quality and affordable medicines not only to the developing w…
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A Look Ahead at BioPharma Manufacturing and Regulation
Therefore, by focusing on these science-based approaches, FDA is confident that the overall quality of pharmaceutical products [will] continue to increase.
Modernizing manufacturing approaches …
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Quality by design for biotechnology products—part 1
…nd controls (CMC) review process in 2004 with the aim of enhancing and modernizing the regulation of pharmaceutical manufacturing and product quality.4 The goal of QbD is to develop robust, well-unde…
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Managing Risk in Raw Material Sourcing
By Agnes Shanley
Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…
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Best Practices in Qualification of Single-Use Systems
66, Application of Single-Use Systems in Pharmaceutical Manufacturing, has been developed to provide comprehensive, high-level guidance about qualification of SUS (1). This paper focuses on technical …