Validation and Regulatory Compliance Trends in Life Science
Validation

Validation and Regulatory Compliance Trends in Life Science

 

Regulatory compliance continues to be an area of increasing focus for both the FDA and foreign governments. The pharmaceutical industry has made great strides over the past decade in complying with FDA guidance, but what next? This article will help you understand some of the trends we're seeing and how they might affect your organization's regulatory compliance efforts.

It's been almost 10 years since the FDA published its guidance for computerized system validation for medical devices and the pharmaceutical industry.

To this day, there are many other regulatory agencies that have their own regulations. For example, the EU requires a thorough Quality Management System (QMS) based on ICH Q9/ISO 15189 standard and GAMP 5 guideline. The European Medicines Agency (EMA) and Health Canada are also moving towards more specific guidelines for computerized system validation.

Companies need to be prepared for future regulations concerning regulatory compliance in addition to current requirements.

Industry has made progress in complying with the FDA's guidance, but what about being prepared for the future?

You may be wondering, “What does the future hold for my industry?” We know that the FDA has made a lot of progress in regulating life science companies. But what about the future? What will happen to validation and regulatory compliance as we continue to enter into this new era of healthcare?

As an industry, we've come a long way in terms of understanding how to comply with FDA regulations and expectations. However, there are still some major challenges ahead that we need to prepare for if we want our businesses and products to remain competitive moving forward.

One trend that's becoming increasingly important is globalization. As different countries begin adopting stricter regulations regarding the quality management system requirements they require from their supply chains, it becomes more difficult (and costly) for companies operating internationally not only because there's more paperwork involved but also because those standards tend not be compatible across borders

CDER has made it clear that it plans to continue its focus on risk-based strategy and scientific quality as well as inspectional oversight of CDMOs.

CDER has made it clear that it plans to continue its focus on risk-based strategy and scientific quality as well as inspectional oversight of CDMOs. To this end, the agency is evaluating its risk-based inspectional strategy for outsourcing manufacturing from a process standpoint, not just a product standpoint.

If you are planning to introduce an outsourcing strategy in 2019 or 2020, you should ensure that the process by which your supplier performs its functions is in line with FDA’s expectations and avoid any surprises during an inspection.

In addition to these trends, we expect more clarity around new drug applications (NDAs) moving forward due to guidance released earlier this year and changes made by Congress last year requiring additional reporting requirements related to clinical trials conducted outside of the United States (CUTA).

The FDA is continuing to look more closely at suppliers, CDMOs and CMOs that manufacture ingredients used in life science products.

The FDA is continuing to look more closely at suppliers, CDMOs and CMOs that manufacture ingredients used in life science products. The goal is to ensure that these organizations are compliant with GMP regulations.

The FDA wants to ensure that:

  • Employees are trained on current Good Manufacturing Practices (GMP) requirements for the products they work on
  • Suppliers follow current Good Manufacturing Practices (GMP) requirements for their facilities and practices
  • CMOs have systems in place to identify and correct any issues with the products they produce

FDA inspections are expected to get tougher in 2018.

The FDA is stepping up its inspection frequency, and that means many businesses need to either improve their compliance efforts or face steep fines.

In a recent article, the FDA announced its goals for 2018. The agency plans to increase the number of inspections it conducts by 25 percent over 2017—a full 500 more inspections than 2016. Inspections are also expected to be more thorough and targeted than in previous years.

In addition, they will be more complex: For example, the FDA may include additional staff members such as epidemiologists during an inspection to determine whether a company's internal controls were adequate for attaining good manufacturing practices (GMP). Finally, even before getting into an inspection itself, companies should expect them to cost significantly more due to increased preparation time needed for an inspection team with greater expertise than ever before!

It's clear that these changes will impact everyone—so what should you do? Here are some tips:

Data integrity continues to be a major focus of the FDA and other regulatory agencies, both domestically and internationally.

Data integrity continues to be a major concern for the FDA and other regulatory agencies both domestically and internationally. This is especially true with regard to clinical trial data, which are relied upon by regulatory agencies as evidence of product safety and efficacy.

In many cases, these data are used to support marketing applications for new drugs or biologics as well as license supplements that may allow an existing product to be used in new indications or patient populations.

  • The FDA has long been concerned about the integrity of data used in its review process; however, recent technological advances have allowed it to more effectively address this challenge. For example, the agency has recently rolled out two new initiatives designed to ensure reliable information: (1) Data Integrity Improvement Plans (DIIPs); and (2) Patient-Reported Outcomes Measures Reporting System (PROMS).

There's increasing pressure on the FDA to be more collaborative with industry to ensure proper regulatory compliance.

As the FDA faces increasing pressure from industry, it needs to find a way to work more closely with companies in order to ensure proper regulatory compliance. Additionally, there is a need for better quality data in order for the FDA to make sure that industry is prepared for changes in regulatory compliance.

Foreign governments have also become more vigilant about ensuring data integrity in their own countries' local manufacturing facilities.

Foreign governments have also become more vigilant about ensuring data integrity in their own countries' local manufacturing facilities. For example, the European Medicines Agency (EMA) has increased its focus on Good Manufacturing Practices (GMP) inspections in response to an EMA report that found 20% of sites undergoing inspection had serious GMP violations.

Since then, the EMA has adopted more aggressive enforcement policies for non-compliance with international standards and good practices. Similarly, China is currently conducting an extensive review of its clinical trial regulations and how they affect data integrity throughout the industry.

The impact of these new regulatory requirements on biopharmaceutical companies operating in China will be significant: if a company's information management systems are not up to par when Chinese regulators come knocking at your door, they could result in significant delays or even total shutdowns until you fix them up again.

The increased scrutiny of clinical data is taking more time and energy from sponsor organizations.

The increased scrutiny of clinical data is taking more time and energy from sponsor organizations. Today’s regulatory environment requires sponsors to provide robust, complete and accurate clinical data to support their marketing applications.

In light of this, it’s important for organizations to have a clear understanding of the importance and value of validating the completeness and accuracy of their clinical data before submitting it to regulators.

All signs point to more rigorous regulatory compliance requirements -- so be prepared!

All signs point to more rigorous regulatory compliance requirements over the next few years. The FDA is increasing its focus on data integrity, which will impact your ability to collect and/or manage clinical data for your products and will also affect how you build and validate manufacturing processes. Additionally, there are a number of other factors that may influence enforcement actions against your company in 2018:

  • CDMOs and CMOs that manufacture ingredients used in life science products are becoming increasingly important targets for regulators as they work to ensure product safety and quality.  
  • Foreign governments play an important role in ensuring supply chain compliance – if you outsource manufacturing or ingredient sourcing efforts abroad, be sure that you’re working with suppliers who can meet both U.S. regulatory requirements as well as those set forth by foreign governments where they operate (e.g., EU).

Conclusion

The medical device and pharma industries continue to face increasing regulatory pressure, but they're also facing a growing number of options for compliance. It's up to you to decide which tools you want to use in your organization. The most important thing is that you keep up with the latest trends so that your team can stay ahead of the game!

 

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