Many of the pharmaceutical companies would like to achieve and it is so-called FDA Inspection Readiness. For most of the time, this kind of readiness is allied with comprehensive quality. All pharmaceutical quality is operated on such a high level that they would be ready for an inspection by the US American health organization. This process provides companies with the assurance that they are always ready to welcome inspectors and accompany them throughout the whole inspection process.
The FDA (Food & Drug Administration) inspection site can occur at any time. The site can make sure that all documentation is ready for review and all staff is properly trained. Practical preparation can help you to ensure the inspection goes as smoothly as possible. Inspections can take place any time, they are only meant to protect the rights, safety, and welfare of the human. It verifies the accuracy and reliability of clinical data submitted to the FDA. Inspections can happen for multiple reasons including new drug applications, safety issues, complaints, and a routine inspection.
Types of Step FDA Inspection
The first step is to ensure FDA Inspection Readiness to familiarize you with various types of inspection. FDA conducts 4 types of inspections to ensure GMP compliance of regulated facilities. It is based on different criteria.
- Pre-approval Inspection: This pre-approval inspection evaluates the manufacturing of the plant’s production capabilities. It seeks whether the plant can effectively manufacture the product to apply to sell. Here are the subjects for pre-approval inspection.
- New drug application.
- Biologic license application.
- Premarket approval application for medical devices.
- New animal drug application.
The FDA investigates all these applications remotely. There are three main objectives of pre-approval inspection.
- Evaluate Readiness for Commercial Industrialization.
- Assess Conformity to Application.
- Data Integrity Audit.
- Post-approval Inspection: Management might need to prepare for post-approval inspections after passing the first approval. The FDA conducts a post-approval inspection after approving the first one. It happens after the product has entered the marketplace. The post-approval inspection is the first opportunity by FDA to verify medical devices. It focuses on process validation and change control.
- Routine Inspection: It maintains FDA inspection readiness and FDA CGMP Training for routine inspections. It is also called a surveillance inspection that generally happens every two years. The FDA is required by law to inspect medical devices every two years. The routine inspection makes sure the facility maintains compliance with good manufacturing. This routine inspection falls into two categories.
- Comprehensive inspections
- Abbreviated inspections
- For-cause Inspection: The FDA conducts for-cause inspections based on past and suspected violations. There are two types of for-cause inspections.
- A compliance inspection is performed to verify corrective actions after FDA has taken regulatory action.
- Inspections have been performed on the basis of past reports and information.
Conclusion:
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