API Testing is also relevant for the FDA - Warning letter to Indian Manufacturer

Access Letter HereThe system was poorly designed, e.g. with ‘blind spots’ and lack of continuous circulation, increasing the risk of biofilm formation.
Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production.
FDA requirements:

Validation of the system, including design, maintenance and continuous monitoring.
Implementation of programmes to monitor and record microbiological and chemical parameters.
Implementation of a risk assessment plan to evaluate the impact of system failures on the quality of drugs distributed in the US. This will include customer notifications and recalls as appropriate.
General measures:

The FDA requires the company to submit comprehensive corrective actions and timelines. These include

Detailed process validation programmes (PPQ) for active ingredients and finished drug products.
Systematic identification and control of process variability.
Monitoring and qualification of production facilities and equipment.
Risk assessment and preventive measures for products already on the market.
In addition, the company is expected to implement measures to ensure that all manufacturing processes comply with regulatory requirements and ensure the safety, quality and efficacy of the products. 

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