Quality & GxP

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OTC Cosmetics Drugs regulation and Good Practices

2020-08-30T09:37:05+00:00February 14th, 2015|

Background and history In 1938, the FFDCA (Federal Food, Drug and Cosmetic Act) granted FDA cosmetic products and ingredients regulation authorization. The statutory provisions of the FFDCA addressing cosmetics [...]

Stem cell medicinal products cGMP and cGTP

2013-12-10T07:20:12+00:00December 10th, 2013|

[vc_row][vc_column][vc_column_text] 1.  Background The usage of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells potential to differentiate into [...]

Good Weighing Practice for lab and production balance

2013-06-18T07:20:33+00:00June 18th, 2013|

[vc_row][vc_column][vc_column_text] 1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case [...]

Corrective And Preventive Actions (CAPA system)

2012-01-22T07:20:22+00:00January 22nd, 2012|

[vc_row][vc_column][vc_column_text]1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical and Medical Devices world. It is mandatory and considered [...]

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