HOLLISTON, Mass.--(BUSINESS WIRE)--Oligo Factory, a leading manufacturer of high-quality oligonucleotides at scale, announces today that it is compliant with current Good Manufacturing Practices (GMP) ...
This article explores the US and EU compliance requirements to ensure patient safety for GMP ancillary materials in cell and ...
On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical ...
As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...
insights from industryDr. Irma Börcsök and Dörte Keimer CEO and Head of Quality AssurancePromoCell In this interview, News-Medical talks to Dr. Irma Börcsök (CEO of PromoCell) and Dörte Keimer (Head ...
Food safety has been regulated across the world for as long as large-scale food production has been in place – since the mid-1800s in the United States, for example. Resulting from a long history of ...
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...
In the world of pharmaceuticals, companies aim to operate under GMP guidelines — a set of production and manufacturing measures to assure standards for medicinal products. But too often, the reality ...
Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune and cardiovascular diseases. As hospitals and translational facilities explore ...
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