Get Prepared for Regulatory Inspections!

To maintain business continuity, the healthcare and pharmaceutical industries should comply with the best practice standards and the most current legislation throughout the lifecycle of their product(s). Regulatory inspections aim at conducting an activity to demonstrate that your company is operating in compliance with the CFR requirements.

Being prepared for a regulatory inspection will help to ease your stress in advance. Permanent Good X Practice (GxP; where X can mean Pharmaceutical, Laboratory, Clinical, and Manufacturing, etc.) “Inspection Readiness” is important and must be considered to be a state of being rather than just a preparation activity. Achieving this state of ‘readiness’ requires an effective and robust Pharmaceutical Quality System, whose on-going suitability and effectiveness are monitored through quality management reviews, periodic internal audits, and monitoring of appropriate Quality Metrics.

To achieve and maintain a sustained inspection readiness state, a pharmaceutical company requires a robust inspection readiness programme, which is essential and can be established at all GxP facilities. This helps in ensuring that the company is adequately prepared for the organization’s next inspection. Regulatory inspections help you to earn credibility and secure your reputation with the Food and Drug Administration (FDA), the European Union (EU), and other Health Authorities, as applicable. The benefits of a well-implemented Inspection Readiness program include:

  • It provides a continued focus on the application of best practices and compliance ensuring continuous high quality of products and patient safety.
  • It develops a culture of quality and best practices as people are always operating at their highest levels and, with time, it becomes the culture and nature of the company.

Conducting Effective Regulatory Inspections

The approach that needs to be followed a number of months in advance of a potential regulatory inspection is as follows:

  • Conducting a GxP analysis/audit.
  • Conducting a mock regulatory inspection.
  • Developing a GxP remediation plan.

Managing a successful outcome of regulatory inspections is all about risk management and it involves understanding your weakness, anticipating how inspectors will perceive it, and preparing your staff to respond appropriately. The biggest risk is the human factor; therefore, your preparation should include training for all site staff to ensure that they are comfortable with it and they put their best foot forward during the regulatory inspection.

Following the regulatory inspection, the senior management is required to act in a sponsorship capacity, which will help in ensuring that the remediation plans and programs are supported with the necessary resources. It is critical that the inspection responses are submitted to the regulatory agency within the agreed and required timeframes.

The time and resources that are used to implement an effective inspection readiness program will prepare you for the crucial regulatory inspections. It should, therefore, identify and facilitate quality improvements within the pharmaceutical quality system of the company while concurrently developing the staff and the overall quality culture within your organization.

For more insights on the essential elements for effective regulatory inspections, attend this Webinar by expert speaker, Danielle DeLucy, MS, who is the owner of ASA Training and Consulting, LLC, which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. You will also learn how to prepare and plan for regulatory inspections.

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