Counterfeit drug revenues are estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organisation states that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market. (more…)
Archive for the ‘Knowledge Base’ Category
Mar 14th
What is GMP ?
Good Manufacturing Practice, GMP compliance, is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMP standards are concerned with both production and quality control. (more…)
Feb 1st
What is the FDA?
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment. (more…)
Oct 12th
What is MHRA?
The MHRA (Medicines and Healthcare Products Regulatory Agency) was set up by the UK Government in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the governmental agency responsible for standards of safety, quality and performance.
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Mar 19th
21 CFR Part 11 Labeling Systems
Everyone in the biotech and life sciences industries knows that 21 CFR Part 11 is not a new requirement ‘ it dates back to 1997, and has remained pretty much unchanged since then. Only its scope has changed.
Initially, the new requirement was widely ignored by both the industry and the FDA. This indifference was not intentional, but can be attributed to a pure lack of understanding by both the industry and the regulators. (more…)
