Types of Inspections in Pharmaceutical Industry

  

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The four different types of inspections conducted by FDA are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. 

Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

1)     Pre-Approval Inspections (PAI)

These Inspections are conducted after a company submits an application to FDA to market a new product. These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product. 

Inspection is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.

The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval.

2)    Routine Inspections 

Inspections are mandated by law every 2 years for class II and class III device manufacturers.  They follow a prescribed method known as Quality System Inspection Technique (QSIT).

The purpose of routine inspections is to follow the Quality System Inspection Technique (QSIT), to systematically assess whether your company is following compliance requirements.

If a serious public health risk is identified during a routine inspection, the inspection type may then switch to a “for cause” inspection. If they find any non-compliance issues or have to issue any 483 observations or warning letters.

3)    Compliance Follow-Up Inspections 

In this inspections review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter.

A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action. Is conducted to follow up on information indicating serious problems at firm.

4)   “For Cause” Inspections:

Initiated at the request of CDRH, ORA Headquarters, Regional or District Directive. Dictated by the source of information and may differ from typical QSIT approach.

These inspections are generally more in depth in particular areas than typical QSIT inspections.

 

 Conducted as the need arises,

Important note in CP, if the Investigator encounters a serious public health risk during the QSIT inspection the investigator may switch to a for cause inspection

During inspection investigate a specific problem that has been reported to FDA. The source of the report can be the manufacturer (e.g., resultant of a recall, MDR), consumer/user complaints, or even a disgruntled employee. 

A “for cause” inspection will focus on the particular issue, but can branch out to cover unrelated elements of the firm’s operations.

These inspections typically are more in-depth than routine inspections, and they may not follow a QSIT approach.

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