As a life sciences manufacturer, compliance with industry regulations is a top priority for your quality management team.

But does regulatory compliance ensure that a company is meeting its quality objectives?

Not necessarily.

Not all companies that are compliant have good quality, but companies with good quality are typically compliant.
There are five imperatives of quality that every manufacturer must address in order to deliver safe, effective, high quality products to the marketplace quickly and consistently, and compliance is just one of these factors.

  1. Product quality
  2. Product safety
  3. Product efficacy
  4. Continuity of supply
  5. Compliance

Even the FDA agrees that compliance alone is not enough.

Under its Quality Metrics Program aimed at pharmaceutical manufacturers, its Case for Quality Initiative aimed at medical device manufacturers, and other quality initiatives (e.g. eMDR, UDI), FDA isn’t asking a company to achieve compliance, but rather to prove a commitment to quality throughout all of its processes.
While this is the case, 66 percent of life science industry professionals surveyed named compliance as their top quality objective for 2019.

A focus on compliance isn’t a bad thing, unless a manufacturer is neglecting its quality performance objectives.

Common pitfalls that lead to a compliance/quality imbalance include:

  • Limited budget and headcount: Regulatory inspections are time and labor intensive and compliance failures are costly, so small to mid-sized manufacturers with limited budgets sometimes allocate the majority of resources to compliance-based activities, while failing to invest in other quality areas.
  • Companies with acquisitions: In some cases, established, global life sciences manufacturers  encompass a number of smaller, less mature entities or divisions with quality operations, that while compliant, do not meet the parent company’s quality standards.
  • Past compliance issues: Regardless of size, if a company had problems with regulatory agencies in the past it may remain hyper-focused on compliance and unable to see the bigger quality picture.

In order to address all five quality imperatives, a manufacturer must have in place processes, systems and metrics to measure them.

Those companies that are only measuring whether or not they have complied with a regulation (e.g. How quickly am I resolving complaints?) are ignoring the bigger picture of whether or not their actions are improving the quality of their operations and products (e.g. Did I resolve the complaints and are patients safer as a result of my actions?).
Compliance is critical and quality management teams must successfully address it, but it’s not the end game.

The ultimate goal of a life sciences manufacturer is to deliver effective and safe products to patients when and where they need them.

That means instilling quality throughout the product life cycle, from R&D out through post-market surveillance, and ensuring all stakeholders – internal resources and external suppliers – are making quality a priority in everything that they do.
Download the whitepaper Balancing Compliance and Quality for more ways to advance your company’s quality goals.