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PAI Readiness Activities

A preapproval inspection, or PAI, is an inspection performed by the U.S. Food and Drug Administration at pharmaceutical and other companies to ensure that the facilities are in compliance with FDA regulations. Failing a PAI is a big setback for these facilities, as it can lead to legal difficulties or contract problems that could result in long delays in the marketing of their products, or even denial of permission to market them at all. If and when those products do hit the market, a bad PAI report in a facility's background can adversely affect its reputation within the industry and with consumers. So preparing for these inspections by using specific PAI readiness activities is key.

  1. Prepare Early

    • The industry handbook, "GMP Compliance, Productivity, and Quality: Achieving Synergy in Healthcare Manufacturing," edited by Vinay Bhatt, recommends beginning PAI readiness activities at the end of Phase II clinical trials for a proposed new pharmaceutical. The handbook advocates that a foreign firm facing its first PAI should be audited for Good Manufacturing Practice compliance at least 18 months before the FDA inspection.

    Evaluate and Test

    • After an initial audit to determine GMP status, along with periodic internal quality assurance checks, the facility in question should have a better idea of where it stands and what it needs to improve or fix. The next step, then, is to begin making those improvements. Assign responsibilities for any deficiencies and have the appropriate teams correct those deficiencies. In addition, it's a good idea to make some test batches of the proposed pharmaceutical.

    Do a Run-Through

    • Before the real thing, hold a mock PAI audit. Be thorough; do not limit the inspection to areas related specifically to the manufacturing of the new pharmaceutical. Have qualified inspectors evaluate every part of the facility, from the heating system to simple cleanliness. This should be done several weeks in advance so that, if adjustments are necessary, there is plenty of time to make them before the official FDA inspection day.

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