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2. Clinical quality management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_Quality...

   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 ...

3. Pharmaceutical engineering - Wikipedia

   en.wikipedia.org/wiki/Pharmaceutical_engineering

   Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.

4. Quality control - Wikipedia

   en.wikipedia.org/wiki/Quality_control

   Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]

5. Pharmaceutical industry - Wikipedia

   en.wikipedia.org/wiki/Pharmaceutical_industry

   The pharmaceutical industry is a medical industry that discovers, develops, produces and markets pharmaceutical goods for use as drugs that are then administered to (or self-administered by) patients. These medications are created and put on the market for the curing or prevention of disease, as well as alleviating symptoms of illness or injury ...

6. Process analytical technology - Wikipedia

   en.wikipedia.org/wiki/Process_analytical_technology

   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).

7. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: