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The challenge to date with PAT for pharmaceutical manufacturers is knowing how to start. A common problem is picking a complex process and getting mired in the challenge of collecting and analyzing the data. The following criteria serve as a basic framework for successful PAT roll-outs: (From A PAT Primer) Picking a simple process.
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
In 1980, the International Society for Pharmaceutical Engineering was formed to support and guide professionals in the pharmaceutical industry through all parts of the process of bringing new medications to the market. The ISPE writes standards and guidelines for individuals and companies to use and to model their practices after.
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
AAPS PharmSciTech is a bimonthly peer-reviewed scientific journal covering all aspects of the pharmaceutical sciences. The editor-in-chief is Robert O. Williams III (University of Texas at Austin). The journal was established in 2000 and is published by Springer Science+Business Media on behalf of the American Association of Pharmaceutical ...
This is a list of notable medical and scientific journals that publish articles in pharmacology and the pharmaceutical sciences This is a dynamic list and may never be able to satisfy particular standards for completeness.