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How to Prepare for an FDA Inspection in Pharmaceutical Manufacturing

The US-FDA and other organizations in charge of quality control inspections represent a real threat to the success of any pharmaceutical company.
The US Food and Drug Administration and other organizations in charge of quality control inspections represent a real threat to the success of any pharmaceutical company. You can prepare for these inspections by learning about the FDA's general quality inspection policies, inspecting your processes, and conducting training on all areas related to the production of products that need FDA regulatory approval.

What To Expect From an FDA Inspection

In preparation for an FDA inspection, it is important to know what to expect from the agency. Inspectors will likely visit your facilities and will ask you questions about the manufacturing process. They may also request specific documents or samples from your company. If you follow the guidelines provided by the FDA, your inspection should go smoothly. Here are some tips to help you prepare for an inspection:
  • Make sure that you have all of the necessary documents prepared. This includes copies of product labels, process diagrams, and batch records.
  • Think about what information you would like inspectors to see during their visit. This might include information on ingredients and manufacturing procedures, sanitation practices, and quality control procedures.
  • Arrange for any necessary tests to be performed before the inspection. This might include testing for harmful bacteria or contamination, verifying that dyes used in products are safe, and checking for contamination during production.
  • Be prepared to answer questions about your products and processes. Be sure to have a solid understanding of the regulations that apply to your industry so that you can answer questions intelligently.

How to Prepare For an FDA Inspection

If you are a manufacturer of pharmaceutical products, then you likely know that FDA inspections occur from time to time. Preparation for an FDA inspection can be helpful in minimizing the potential for problems during the inspection, and can lead to a smooth and successful visit. This blog post will discuss some of the steps that you can take to prepare for an FDA inspection.

First, it is important to understand the different types of FDA inspections that may occur. The four most common types of inspections are Premarket Approval (PMA), Good Manufacturing Practices (GMP), Foreign Supplier Verification (FSV), and Risk Evaluation and Mitigation Strategy (REMS) inspections. Each type has its own specific requirements that must be met in order for the inspection to be considered successful.

To prepare for an FDA inspection, it is important to have a good understanding of the requirements associated with the type of inspection that you are expecting. For example, GMP inspections often require documentation of materials and processes used in manufacturing products, while PMA inspections typically examine product inventories and documentation related to investigational new drug applications. It is also important to have a complete understanding of how an inspector will conduct the inspection, as well as any special paperwork required.

The Importance of a Pre-Inspection Plan

When pharmaceutical companies receive notification from the Food and Drug Administration (FDA) of a planned inspection, they need to ensure that they are prepared to answer any questions posed by FDA agents. A pre-inspection plan is key to ensuring that all areas of the manufacturing process are properly documented and that potential problems are identified and fixed before an inspection takes place.

A pre-inspection plan should include:
  • Documenting all ingredients used in the manufacture of pharmaceutical products
  • Ensuring that all production processes are in compliance with Good Manufacturing Practices (GMPs)
  • Determining whether any Grimm equipment used in the manufacturing process is subject to registration or has been deemed safe and effective by the FDA
  • Recording environmental data, including temperature, humidity, air quality and chemical levels in workplace areas
  • Keeping accurate time records of daily activities while at work and during on-site inspections
  • Implementing a structural fire safety plan
  • Ensuring that any changes made to the workplace after a pre-inspection will be reviewed

What To Do After the Inspection

The FDA inspects pharmaceutical manufacturers regularly to ensure the safety and quality of their products. Following an inspection, the FDA may require any one or more of the following actions:
  • Change product manufacturing procedures
  • Increase monies spent on equipment or facilities
  • Create a prevention plan
If any of these actions are required, it is important to take action as soon as possible so that the company can continue to produce safe and quality products. Here are a few tips for preparing for an FDA inspection:
  • Review all agency requirements and guidelines, especially those related to process improvements, new equipment implementation, safer ingredients use and Hazard Analysis Critical Control Points (HACCP). Specific attention should be given to areas such as Good Production Practices (GPPs), production records verification and audits, sterility assurance documentation, and quality control procedures.
  • Locate all documentary evidence necessary to support proposed changes. This includes product specifications, production records, results of process tests, etc.
  • Ensure that all personnel have received training in GMP and in FDA compliance procedures. An effective training program will include instruction on GMP concepts as well as specific FDA auditing methods. The use of actual FDA compliance checklists is recommended.
  • Obtain an analysis of the outcomes of previous HACCP audits conducted on your company. The evaluation will include a description of the current system and its ability to provide product safety, controlling and records-based inspections through the HACCP process.
  • Continue to maintain product specifications including GMP requirements. Perform regular internal reviews and record adequate proof of compliance with all processes, control programs, production procedures and facilities.
  • Maintain employee-level training records for supervisors and operators. Employees should receive training every 6 months plus refresher instruction during annual vendor orientation visits.
  • Audit formulations, flavorants coatings as well as traceability information/records utilizing company-approved verification methods as well as additional procedures when necessary. Maintenance of accurate and complete records/receipts with each product activity/material movement, specifications, certificates, sales receipts, and packing slip documentation.


Pharmaceutical manufacturing is a highly regulated industry, and as such, companies must take steps to ensure that their products go through the necessary safety checks before they are released to the public. Fortunately, preparing for an FDA inspection isn’t too difficult. The key is to have a well-organized system in place and make sure that all documentation is up-to-date. Additionally, it can be helpful to have someone on staff who understands FDA regulations – Ideally, this person should be responsible for ensuring that all documentation meets all applicable requirements.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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