Good Manufacturing Practice (GMP)

 Good Manufacturing Practice (GMP) Is a manufacturing and testing process that helps to ensure a product of quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There is a set of general concepts that have to be followed during production. When a company develops it's a quality system and manufacturing methods, it can be able to satisfy GMP requirements in several ways. It is up to the company to determine the most efficient and effective quality process.

For the pharmaceutical industry, GMP is a key term. Good Manufacturing Practice (GMP) is, according to the World Health Organization (WHO), a mechanism to ensure that products are produced and regulated in a safe manner according to quality standards. The main purpose of this is to reduce the risk involved in pharmaceutical production, which by testing the final product is difficult to eliminate. Severe consequences that exist in the absence of provisions such as cancelation of the license, restriction of the drug, or claim of neglect or failure to comply.

For manufacturer Ayush Sidha Unani (ASU) drugs described in rule 157 of drugs & cosmetics rule 1945 with conditions as specified in schedule T/ GMP are to ensure that;

➲ The authentic raw material of prescribed quantity and free from contamination has been used in the manufacturing of drugs

➲ The manufacturing process is as prescribed to maintain the standards

➲ The manufacturer has adopted adequate quality control

➲ The produced drugs that are released for sale are of acceptable quality

Who needs GMP:

➲ Drug Manufacturer

➲ Ayush Manufacturer

➲ Drug Importer

➲ Medical equipment manufacturer

➲ Personal Protection Equipments

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