How Healthy Are Your GxP Processes?

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5 key areas to support continuous improvement in a rapidly changing environment

The challenges that the life sciences industry is facing today have created a new operational environment that makes it more challenging for you to maintain GxP compliance. Many organizations have begun to understand what work can be done remotely and what has not worked particularly well. Although offices may be starting to open and regulatory inspections are resuming, many resources are no longer available as budgets have been restricted.

In addition, the demand for your products may have changed. If you manufacture products for elective surgery, then you have seen the negative impact that the last few months have brought. Conversely, there are other businesses, for example, those that manufacture ventilators and personal protective equipment, that have seen the reverse.

With all these factors in play, this is a good time to review the health of your GxP and QMS processes. In this post, we’ll examine five key areas to explore to ensure that your organization is prepared to maintain regulatory compliance and process efficiency, while navigating the ongoing challenges and limitations presented by COVID-19.

  1. Understand Remote Inspection Best Practices and Guidance
    Staying compliant and meeting regulatory expectations is key. To do that, you need to understand what agencies and notified bodies expect and how they will undertake remote inspections going forward. Although there are reference documents available, and manufacturers have also received guidance from notified bodies, it’s beneficial for you to understand how these audits should be conducted specifically within your organization.

    If you haven’t been part of a remote inspection already, it’s important to know that they vary in their approach, and that they may uncover some additional complications. This means that being inspection-ready has taken on a new dimension.

    You may be used to running mock inspections under the normal setting, but it’s important that you also run mock inspections for any scheduled remote inspections in order to best prepare for these activities.

  2. Correct and Respond Quickly and Properly
    Mock inspections are critical because getting it right the first time is increasingly important; agency and notified body schedules for follow-up and repeat inspection will be very full due to a backlog from the shutdown. For the same reason, how you respond to any nonconformances and findings, especially from notified bodies, will be important.

    This makes follow up to corrective actions critical. When corrective actions are sent, whether in response to a 483 observation or a notified body audit nonconformance, it’s important to minimize extra rounds of follow-up and additional passes back and forth whenever possible.

    If you get the follow up right the first time and eliminate the review period that you have on these corrective actions, you’re going to make your agency and notified body happy. This means that you’re going to avoid delays and resolve that nonconformance as quickly as possible.

  3. Deepen the Culture of Quality
    Quality Culture is an important part of any organization that is occasionally overlooked, particularly in times of crisis. This is especially true now when you may have typically relied on some personnel who were with you prior to the shutdown that may not be available to you now.

    Despite these challenges, it’s important to encourage a culture of quality, and that culture should ultimately be self-regulating. When there are issues with quality culture, you’ll see people closing the doors on issues instead of really fixing them, which can lead to larger problems later. The internal culture of being able to identify nonconformances and address them before they expand will help when you go into inspection mode with third-party auditors and inspection agencies. Improving quality culture will also reduce the cost of overall quality. After all, if your organization cannot afford the cost of a complaint culture, it most certainly cannot afford the expenses of a Warning Letter or Consent Decree.

  4. Reexamine Supplier Process Health
    Health checks are not just for manufacturers; health checks are for suppliers as well. Over the past few months, although your organization may have been taking product from specific suppliers, it’s possible that many of their other customers haven’t been taking product. These suppliers may be facing a squeeze in the near term. This makes is especially important to take a fresh look at supplier capabilities and processes. Were they good enough before? Are they still valid now? It is a particularly important for virtual companies to look at supplier qualification and supplier monitoring, and to review methods for assessing new suppliers.
  5. Evaluate Both Compliance and Effectiveness
    Being compliant is one key need, but you also need to look at how effective your processes are. This means not just looking at compliance, but really evaluating the effectiveness of your process. The only way to understand that is to put suitable metrics in place to identify changes being made and improvements over time. It is certainly possible to be both compliant and efficient!


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Manostaxx – Industrial Management Consulting

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