GMPs require high cleanliness and maintenance standards to prevent contamination and ensure product quality in pharmaceutical ...

Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines. This database, available at http://gmp.pharmout ...

To meet the requirements of regulatory agencies, pharmaceutical products are produced in a controlled setting. One example of such a controlled environment is a cleanroom, which is used to minimize ...

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 ...

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) ...

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 ...

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