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Understanding How FDA Warning Letters Can Hinder Your Company

January 30th, 2014 by

FDA Warning LetterUnder the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by FDA to document concerns discovered during inspections.

The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional [...] Read More

GxP-CC International Compliance Services Launches New Website

January 27th, 2014 by

GxP-CCWiesbaden, Germany : GxP-CC, an international compliance services organization targeting the pharmaceutical, medical and dental industry, recently launched a new website.

The website features a modern homepage design, an intuitive navigation and in-depth content on the company’s quality management and [...] Read More

FDA 21 CFR Compliance as a Gateway to Market Viability

January 27th, 2014 by

FDA 21 CFR RegulationBefore selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration (FDA) and other regulatory bodies.

For specialized companies trying to stay legal, such a herculean task is practically impossible without outside assistance, when one considers the restrictions that [...] Read More

How to Ensure CSV Compliance For Your Software

January 27th, 2014 by

CSV ValidationCSV (Computer System Validation) compliance is something that the FDA and the European Regulatory Authorities take very seriously. Software programs that are not in compliance with validation and the associated infrastructure qualification measures could result in a product recall by the government.

Regardless of whether a software program is developed by a company itself or is purchased off-the-shelf, it should have a defined objective before it is used for a specific [...] Read More