API MANUFACTURING: COMPLYING WITH INTERNATIONAL GMP REGULATIONS

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For a long time, api manufacturing companies in Asia have been struggling with the GMP regulations because of several factors.

At one point, a famous Indian api manufacturing had to be banned by the FDA after the company was proven to be manipulating their lab tests. Well for the Asian manufacturers to penetrate the western market, there is no doubt that they need adhere to Good Manufacturing Practice (GMP) guidelines.

There has been a research conducted in Europe and USA, and it was discovered that many of the APIs available in many pharmaceuticals originate from Asia. And for decades, these pharmaceutical ingredients have been available as trading goods. This has shown that many api manufacturing companies do not comply with the GMP regulations. Non-compliance to the regulation will automatically compromise the quality of APIs produced, and this will in turn affect the health and safety of consumer patients.

There are many reasons as to why many api manufacturing companies may deviate from quality regulations.

 

Some of these reasons may be that; the impurity profile may have been aggravated, pharmacological impairment of activities and the changing of physicochemical properties.

To ensure compliance of the GMP regulations, there has to be an onsite audit of api manufacturing facilities in regards to the ELP which is the European Legal Provisions. Although, regulatory bodies can opt for GMP certificate, it is so unfortunate that they may not be sufficient enough to replace onsite API audits.

Rules and regulations are usually passed, not to frustrate the efforts of different companies, but with an aim of ensuring that these company produce quality products. If the APIs produced are of high quality, then this is an assurance of the safety of consumers at large. Therefore compliance measures should be put in place for all companies to strictly follow stipulated guidelines.

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