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Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures

26

Jun

2019

The FDA stands for Food and Drug Administration. FDA is a crucial part of the US Department that is dedicated towards offering health and human services. The primary function of this organization is to oversee the production of foods, pharmaceuticals, medical devices, and other consumer products.  The development of biological commodities that are used for treating allergies and making cosmetics are monitored by this department. When a product is found to be unsafe to use, at that time the primary job of FDA is to issue recalls. The formation of this agency dates back to 1848 and it is The US’s oldest consumer protection agency.  The mission of this agency is to protect the Americans from the use unsafe and unhealthy products. The life of people is often endangered by harmful radiation that comes from electronic gadgets and devices. All those products that give off harmful radiation, they can only be need after getting a preapproval from the department. 

Here, we take you through FDA’s Pre-Inspection procedures which are detailed as under:

  • FDA gives approval for a certain commodity if the different methods and the controls used in the manufacturing, packaging, and holding meets the required quality standards. 
  • Failure to adhere to the quality standards would lead to regulatory actions against the drug.
  • Before the start of the pre-inspection process, the organization appoints FDA us agent who pays a physical visit to check the onsite location of the establishment. 
  • If the organization is found to be in Chemistry Manufacturing and Controls section of Abbreviated New Drug Application or a New Drug Application, FDA engages its representatives to do a thorough review of the files and documents of the establishment.
  • For a pre-approval inspection, evaluations are primarily done on API and API manufacturers, primary packaging labelling sites, finished dosage manufacturers, and the establishment that are engaged in crude extraction.
  • Some establishment that are not being evaluated are exhibit batch manufacturers, secondary packagers, intermediate manufacturers, and component manufacturers. 
  • There are different criteria followed by FDA during the inspection procedure.
  • The criteria are based on the risks which are product risk, process risk, and facility risk.
  • FDA sends a team of individuals to perform the inspection. The team includes chemistry experts, microbiology experts, investigators, facility expert, and formulation expert.
  • In the pre-approval inspection, the FDA assures that an establishment possesses the capabilities of manufacturing a drug. Also, it ensures the information submitted by the establishment is true and accurate.  
  • The inspection determines the establishment uses a standardized system to get the controls over the manufacturing process.
  • The formulation and manufacturing processes are verified. The methods are checked for consistency. 
  • The agency audits the raw information. They also verify and ensure all the data that are submitted to the CMC section are correct and authentic.
  • One of the important parts of the approval process is the inspection.  At the end of the conclusion process, the investigator will make a recommendation.  Depending on the outcomes, the investigator may recommend approval or withholding approval. 

Now that you are made aware of the inspection process, get ready for the pre-approval inspection process today!

 

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