Search results for " pharmaceutical" in Articles / App Notes
Article
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…
Article
Assessing Manufacturing Process Robustness
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzena Ingram, Robert Rhoades
The pharmaceutical regulatory landscape and pharmaceutical development have be…
Article
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…
Article
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 …
Article
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…
Article
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 …
Article
Pharma Investments Reflect Key Industry Trends
18-22
Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in turn is affect…
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Navigating Emerging Markets: Middle East and North Africa
On the pharmaceutical side, countries like Morocco have enacted legislation in the past decade to attract foreign investment in the country.
While the Middle Eastern environment remains unsett…