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Outsourcing of API Manufacturing – Are Strict Regulation and Quality Checks Necessary?


An API needs to pass quality checks at two major levels:

In the country where it is produced.

In the country where drugs are manufactured and are sold to end-users.

This is why an API manufacturer has to arrange for 3rd party audits whose certification ascertains that all industry standards are followed during the manufacturing process of an API in their industrial setup.

In case, a company fails the inspection process, they are issued a warning and all dealings with drug manufacturers are temporarily put on hold until they pass re-inspection audits. This is done to ensure that all APIs are safe for human use and the consumption should not lead to any ill-effects that can cause serious illness and even death in some cases.

There are multi-level checks of batches of API produced:

Firstly, it will be analyzed by the laboratory of the API manufacturer itself.

Secondly, 3rd party laboratory will conduct an inspection of the safety and quality parameters of the API manufactured.

Thirdly, the drug manufacturer or pharmaceutical company will test the API before trading.

Lastly, many batches will also be tested by the hospitals where the drug will be prescribed to the end-users.

Product categories that fall under the API regulatory control are:

Generic products with/without scheduled poison.

New drug products.

Health supplements, veterinary products, biotechnology products, and traditional products do not come under API regulatory control.

Good manufacturing practices

This is the term that most API manufacturers have to abide by. These are the standards that are internationally recognized to produce safe API for manufacturing a drug. Every country has a set of regulations set in place which contains all the guidelines that an API manufacturer must follow as a part of GMP.

Finding a reputable API manufacturer who follows GMP very strictly is a must if we want to assure that the drugs that are manufactured in the pharmaceutical industry are safe for human administration. Some of the parameters that can determine the reputation of API suppliers are:

A background check should be able to reveal any loopholes in their manufacturing processes, their turnover, capacity to the manufacturer, and their past client history.

Checking the records of quality parameters followed while procuring raw materials, manufacturing API, storing and packaging of the API ingredient.

Also, confirm whether the API supplier is ready to take responsibility for any failed quality check or not.

Their readiness to produce an API in a specific time frame speaks a lot about their efficacy as an API manufacturer.

API is fundamental to the modern drug manufacturing process and cutting cost should not be the only criteria that can be applied to the production of an active pharmaceutical ingredient as it can adversely affect human health if the above-mentioned regulations and practices are not followed strictly.

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