Manufacturing, pharmaceutical quality assurance

FDA. Guidance for Industry PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER),... 

Process Analytieal Teehnology (PAT) - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. 

US Food and Drug Administration, PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, 2004, available http //www.fda.gov/CDER/GUIDANCE/6419fnl.htm accessed 27 November 2009. 

Since the mid-1970s validation has become an increasingly dominant influence in the manufacture and quality assurance of pharmaceutical products. In 1976 the FDA proposed a whole set of current GMP regulations which were revised several times. 

Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (19) This guidance describes a regulatory framework that will encourage the voluntary development and implementation of innovative approaches in pharmaceutical development, manufacturing, and quality assurance. Many new... 

PAT—a framework for innovative pharmaceutical manufacturing and quality assurance (September 2004)... 

Guidance for Industry PAT—Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance... 

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2004, Sept.), Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance, DHHS, Rockville, MD. 

For computer systems that are an integral part of the operation of a manufacturing plant or process, the system PQ may be conducted in conjunction with process validation. The combined activities are generally led by the pharmaceutical manufacturer s quality assurance function and can be in the form of an extended process trial. 

Pharmaceutical data on dosage form, including product specifications, manufacturing data, quality assurance procedures, stability data, validation procedures and bioavailability studies. 

To gain buy-in and input from all the key functions at the start of development (such as Pharmaceutical Development, Safety, Clinical, Manufacturing Operations, Quality Assurance, Regulatory and Marketing)... 

---