Strategic Planning for Your Facility's Pre-Approval Inspection

Authored by Jim Watson, Vice President

The journey from drug discovery to commercialization is marked by critical milestones, one of which is ensuring that your manufacturing facility meets FDA Pre-Approval Inspection (PAI) requirements. Unfortunately, many emerging biotech and pharmaceutical companies delay their facility planning, leading to costly setbacks. With early and strategic preparation, organizations can confidently navigate the PAI process and pave the way for successful drug commercialization.

What Triggers a PAI?

The FDA conducts a Pre-Approval Inspection to evaluate product, process, and facility risks. This rigorous assessment ensures that the facility is capable of manufacturing the proposed drug and that submitted data are reliable and complete. If a PAI is initiated, the FDA assembles a team of subject matter experts in chemistry, microbiology, process/facility operations, and formulation to assess the company’s readiness.

Before a PAI, the facility may also undergo an evaluation. Facility evaluations are conducted for:

Key FDA Evaluation Areas During a PAI

The PAI focuses on three core aspects of manufacturing compliance:

1. Readiness for Commercial Manufacturing: Evaluates the facility’s quality systems to ensure they can consistently maintain control over commercial manufacturing operations.
2. Conformance to Application: Verifies the formulation, manufacturing or processing methods and analytical methods are consistent with descriptions of the application for clinical batches, commercial scale batch, and Active Pharmaceutical Ingredient(s).
3. Data Integrity Audit: Audits raw data, hardcopy or electronic, to authenticate the data submitted in the application. Verifies that all relevant data were submitted such that product reviewers can rely on the submitted data as complete and accurate.

Preparing for a Successful PAI

Being underprepared for a PAI can have significant consequences, including delays in commercial production and damage to your company’s reputation. A failed PAI could even jeopardize drug approval.?There are specific stems a company can take to be fully prepared for the PAI.

Plan to Mitigate Risks by Objective

To ensure a successful PAI, companies should take a proactive approach to compliance. One way of doing so is by leveraging the expertise and objectivity of experienced project managers or third-party specialists to guide you through a mock PAI, identifying potential gaps in areas such as cGMP, quality systems, equipment, processing methods, documentation, and data integrity. By addressing challenges early, companies can streamline preparation, mitigate risks, and boost confidence in their facility's readiness, significantly improving the likelihood of a seamless and successful PAI.

About Project Farma

Project Farma, a Precision for Medicine company, specializes in providing comprehensive biomanufacturing strategies and execution services. We have successfully industrialized over 10 commercial cell, gene, and novel therapies, executed 60+ facility builds and capital expansions, and managed $6B+ in technical operations capital investments.

With expertise spanning startups, leading life science corporations, advanced therapy organizations, universities, hospitals, government agencies, and more, our team delivers proven technical operations and manufacturing solutions that shorten time-to-market, helping patients in need.

Visit our website to learn more about Project Farma and how Precision for Medicine’s integrated capabilities—across labs, clinical trials, manufacturing, and data intelligence—can help your organization bring therapies to life.