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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2] Other publications in the GAMP series include: GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
The material cost of a chemical process is the sum of the costs of all raw materials, intermediates, reagents, solvents, and catalysts procured from external vendors. Material costs may influence the selection of one synthetic route over another or the decision to outsource production of an intermediate.
International Journal of Pharma and Bio Sciences; International Journal of Pharmaceutics; Journal of Biomedical Nanotechnology; The Journal of Clinical Pharmacology; Journal of Controlled Release; Journal of Ethnopharmacology; Journal of Generic Medicines; Journal of Microencapsulation; Journal of Oncology Pharmacy Practice; Journal of Pharmacy ...
Since the 1999 publication of Good Manufacturing Practice for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ...
The National Institute for Pharmaceutical Technology and Education (NIPTE) is a non-profit scientific and research and development organization that was established in 2005 and incorporated in June 2007 in the State of Indiana. [citation needed] Its offices are currently located in Minneapolis, Minnesota.
In the pharmaceutical industry, a wide range of excipients may be blended together with the active pharmaceutical ingredient to create the final blend used to manufacture the solid dosage form. The range of materials that may be blended (excipients, API), presents a number of variables which must be addressed to achieve target product quality ...
Pharmaceutical Development and Technology is a peer-reviewed pharmaceutical journal that is published by Taylor & Francis. It covers research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems , emphasizing practical solutions and applications to theoretical and research-based problems.