Compliance Series 2: Focus on Quality Not Compliance

The Office of Pharmaceutical Quality (OPQ), launched in 2015, will be used to carry out the FDA’s long term plan to establish a uniform quality program for drug manufacturers. The OPQ’s oversight will include both domestic and foreign facilities with the overarching goal to shift the mindset of pharmaceutical manufacturers from meeting compliance to developing quality drugs.

Managing Compliance Risks with EAM/CMMS Series

In our previous blog on recent FDA activity, we covered recent FDA history and what to expect from the FDA in 2015. With the FDA’s risk based selection approach to conduct inspections, it is important to balance investment and compliance to drive overall product quality while maintaining productivity and profitability. For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.

Why the Office of Pharmaceutical Quality?

In combination with recent budget constraints on the FDA, there is a rapidly increasing number of both domestically manufactured and imported healthcare products. In order for the FDA to continue to regulate products given their budget constraints and the increasing size of the marketplace, the Office of Pharmaceutical Quality will work to define a process for uniform oversight of new drugs, generic drugs and OTC drugs. With a single, team-based quality assessment, the FDA will be able to efficiently inspect facilities and ensure the quality of drugs are available.

In addition to the constraints that the FDA is facing, there are a number of long term goals they are looking to implement. The biggest goal is a shift in focus for Life Sciences companies. The FDA wants to create a marketplace in which companies focus on manufacturing quality products rather than meeting regulations. This is a subtle shift in thinking, but will result in manufacturers creating better treatments for patients. With a focus on quality, it is even more important to carefully manage compliance risks by leveraging technology such as EAM/CMMS applications – which we will discuss more in future blogs.

To shift focus to quality, the FDA has proposed a new set of inspection techniques.  Uniform drug manufacturing oversight means that rather than just 483s and warning letters for companies that violate regulations, the FDA will provide a full scale assessment of product manufacturing and for each area of the inspection rate the facility based on 6 different scores. According to FDANews, the 6 proposed scores include: critical failure, major failure, minor failure, acceptable, exceeds, and superior.

Risk-Based Inspections
These six scores give the FDA the ability to recognize manufacturers with superior quality. Scoring also provides a way for the FDA to compare facilities on a standardized scale – a new factor in their risk-based inspections. These scores however, will not be the only factors taken into consideration by the FDA for inspections. They will also consider if a facility is meeting GMP compliance, has previous violations and their ability to respond.

What Does the OPQ Mean for Pharmaceutical Companies?

With the new Office of Pharmaceutical Quality now in place, companies need to carefully scrutinize quality efforts in their own facilities. As noted earlier, companies who play an active role in quality and who have a clear history of GMP violations will be less likely to be inspected by the FDA.  In our next blog, we will discuss what OPQ means for companies and how, by leveraging EAM/CMMS, companies can efficiently manage compliance risks.

For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.

Check out the other blogs in our Managing Compliance Risks with EAM/CMMS series:


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