Products entering FDA-regulated industries must undergo FDA pre approval inspection (PIA). Companies ingraining PIA in their processes have been successful in product development. Big and small organizations should be thorough in preparation because it determines whether their product will be approved. If any issues are found, a manufacturing site can be rendered as having difficulty in applications.

Companies manufacturing drugs should put significant time and energy into preparing. They must have inspectors and external reviewers who conduct mock assessments needed before pre-approval inspection (PIA). However, a mock audit is just one of the many steps of preparing for pre-approval inspection. Preparation is a vast project incorporating training, organization, compliance, and validation.

What is Pre-Approval Inspection

FDA performs pre-approval inspection to ensure that the application used in manufacturing a certain drug is correct and the data submitted is complete. Drugs approved by the FDA have a catalog of Drugs@FDA. FDA approval is vital because it allows research on how drugs work on both children and adults. It also helps in determining the correct dosage, route of administration, and drug interactions in children. If the FDA approves a drug, it means that the drug’s benefits and risks have been determined and it’s ready for use.

If a manufacturing site has just been named in BLA, NDA, ANDA, or PMA, it must pass through pre-approval inspection. PIAs are also carried out in several application facilities such as packagers, API manufacturers, and testing labs. FDA inspectors confirm the following during pre-approval inspection.

  • The site can be relied on for manufacturing.
  • The manufacturing site complies with the applications.
  • The manufacturing site has scaling operations.
  • The site uses ideal analytical methodologies.
  • The manufacturing site complies fully to CGMP
  • The manufacturing site produces accurate and complete data.

Pre-approval Criteria Used by PIA Investigators

  • Several changes made to the process, site, and/or product
  • A facility’s name appears for the first time in the application.
  • APIs that are highly risky
  • Therapeutic drugs that have a narrow range
  • Official action indicated (OAI) status, or there has not been any recent inspection.
  • Entities of new molecular
  • Risk of the supply chain
  • Sites that produce drugs that are difficult to manufacture

After confirmation and using these criteria, FDA inspectors know which manufacturing sites are well prepared and which ones are not. It also helps to stop hazardous applications in manufacturing that could harm the users of those products.

Pre-approval Inspection Preparation

Experienced inspectors are chosen at the beginning of the pre-approval inspection. Their job is to identify significant matters in the inspection. Firm representatives and inspectors meet in one room where they conduct the main audit. Also, document reviewers, SMEs, and other personnel work in one room where they prepare materials.

Conduct a Mock Pre-Approval Inspection

Holding an assessment PAI helps companies to make the necessary changes before an FDA inspection is conducted. An effective Mock PAI helps in several ways, including;

  • It enables to produce a clear report about Mock inspection.
  • It determines the processes and other activities that need remediation before an FDA approval.

A Mock PAI’s overall role is to choose a Project Manager who can be helped by other team members to explain the assessment’s scope, come up with an audit timeline, and plan and prepare the needed resources. When a third party helps an inspector, they ensure the project is a success. Together, they have the knowledge required for a company’s successful product development.

Conduct Necessary Pre-Inspection Remediation

During the mock inspection, several risks are noted. After the mock inspection report is complete, remedies should be carried out following the risks seen. Again, they ensure to use the required mechanisms to carry out the process. Consultants and third-party contractors can help the firm with the pre-inspection remediation process. When remediation is carried out early, any issues found are corrected.

FDA’s Compliance Program Guide

The FDA’s program has guidelines that educate its field and staff about its program requirements. The guidelines explain how FDA inspectors and other impacted staff conduct inspections in manufacturing sites. Again, the guides have various instructions on several areas, including;

  • What should be included during the inspection
  • What should be in the investigators’ reports
  • Where the completed reports should go.

The FDA compliance officer also gives instructions in the compliance guide. The officer reviews the findings, identifies problems and gives the go-ahead if the samples should be collected. If the officer finds any issues, the collection of samples can be halted. However, if a few problems are found, samples can be collected ready for the next step.

Keep the FDA’s Role in Mind

Some industries tend to forget about the role of the FDA in the preparation of product development. This can negatively impact product development. The FDA inspector’s job is not to recommend the firm instead to find where they go wrong. However, nowadays, if a company is transparent to the agency, it could get a favor in return. This is advantageous because the manufacturers know where the problem lies and how to correct it.

How to Ensure a Successful Pre-Approval Inspection

Companies that comply with the following approaches have a successful PAI.

  • The company is aware of existing problems before an inspection.
  • The senior management knows the issues to be expected during the site inspection.
  • The sponsors carefully choose the contractors in applications and ensure the site is ready for pre-approval inspection.
  • The combination of operations and quality ensure the identification of any deviations. The personnel responsible is accountable if any issues are identified.
  • Quality and inspections combine efforts to present significant subject matters.
  • The firm should have a development report containing documentation to help understand the application product and process. It serves as a basis for justifying the process so that it can be filed.
  • If any problems are found, it’s advisable to communicate to the manufacturing site to remedy the problems before the product is launched.

Firms that respond positively to readiness preparedness get positive reviews from an FDA inspector. They make no mistakes, and their product preparedness is a success. If there are mistakes, they remediate them before a pre-approval inspection is conducted. Again, if firms read through the FDA’s guide program, they know what to expect when the FDA inspectors visit their manufacturing site.  Thus, manufacturing sites can produce approved drugs and other products because their risks and benefits have been identified.