Imagine facing a Class 2 recall after your product ships!

In 2010, Johnson and Johnson found itself battling a firestorm after the FDA recommended a Class 2 recall of millions of bottles of OTC infant's pain relievers due to manufacturing quality problems.

The headaches didn't end in 2010. Five years later, the company was still battling the FDA over how the recall was conducted. Six years later, lawyers were still offering free consultations to affected families.

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Understanding the objectives of quality assurance and its benefits can help your company to put appropriate emphasis on and allocate sufficient resources to this crucial component of your business.

5 Objectives of Quality Assurance in the Pharmaceutical Industry

Do you want to know the foundational principle that separates every industry-leading pharmaceutical company from the rest? It's that quality is an investment which leads to competitive advantage rather than an expense which is required to maintain regulatory compliance.

Look at how Medtronic, one of the leading life sciences companies in the world, approaches quality:

"We manufacture safe, high-quality products not only to further our Mission, but also to build trust, reduce reputational risk, and improve operational efficiency."

So, certainly, there are other benefits to quality assurance in the pharmaceutical beyond just staying on the good side of regulatory bodies. Here are five of the most prominent.

1. Protect the Public

Your number one goal is — and always should be — to protect the public. You are creating medications that can literally change someone's life for the better.

Conversely, if your quality standards aren't where they should be, those same life-changing products can cause irrevocable harm and even death. Your customer's safety is paramount and should never be taken for granted as you seek to grow your company and make a profit for your investors.

As you implement a pharmaceutical quality assurance plan, keep the end-user at the forefront of the minds of all team members.

How to Achieve this Objective:

You must implement strict quality control processes that include:

  • Document control
  • Employee training
  • Deviation
  • Laboratory OOS (Out of Spec)
  • Corrective and Preventive Action (CAPA)
  • Internal Audits
  • Management Review

2. Inspire Professional and Consumer Confidence

According to Edelman's 2018 Trust Barometer, pharma remains the least-trusted healthcare sector at 55% globally. You also suffer from being the most frequently blamed by survey respondents for the high cost of care.

There is definitely a crisis of public trust at play right now. The People vs Big Pharma does a great job of explaining all of the underlying confidence issues that exist in the pharmaceutical industry.

The pharma sector's noble goals of saving lives and curing diseases are often buried under the latest news about high drug prices, opioid scandals, and anti-competitive behaviors. So what can you do?

How to Achieve this Objective:

You are unfortunately participating in one of the flagship global issues of the 21st century. Consumers want fair access to affordable and life-saving new treatments, so rebuilding trust with prescribing professionals and inspiring consumer confidence isn't going to happen overnight.

There are a few steps you can take to start moving things in the right direction. Most of them involve bringing the human side back into your industry.

  • Learn from Pharmaceutical Research and Manufacturers of America's (PhRMA) GoBoldly initiative and talk about the innovations and hard work that goes into creating life-changing medications.
  • According to David Mitchell, president and founder of the US-based campaign group Patients for Affordable Drugs, "... do something that's real." He calls for pharma groups to open communications and take a more proactive role in discussions to reform drug pricing. The Perfect Quality Assurance Plan for Pharmaceutical Companies

3. Safeguard Against Negative Publicity

Swaying public opinion and making them fall in love with the pharma industry may not happen quickly, but there are steps you can take to avoid being the latest scandal.

There are lawyers that literally make their living building up class-action lawsuits against drug manufacturers that fail quality standards.

Some bad interactions are unavoidable. Consumers will take the medication in a way not originally intended, it will interact with something else they are taking, or there will be some other unexpected side effect that didn't occur in your clinical trials.

However, there are things that you can anticipate and impact.

How to Achieve this Objective:

You can control the quality of pharmaceuticals that you produce, the literature that you provide to physicians, and your response to complaints.

  • Invest in an Enterprise Quality Management System (eQMS) that can help you track quality across your entire supply, production, and distribution chain.
  • Establish a Corrective and Preventive Action (CAPA) system to support self-correcting quality systems within your organization and assure that quality issues are resolved.

One of the keys to finding the right eQMS for your company is understanding how the needs of your organization change with the phase of growth that you're in. A pharmaceutical startup or scale-up, for instance, doesn't need the extensive customization capabilities that a big pharma corporation does. These younger companies need simplicity, ease of use, and the ability to scale their systems quickly.

The Qualio eQMS is built with these types of companies in mind. If your pharma organization has between 5 and 500 employees, we may be the perfect fit for you. Learn more about our solution here.

RELATED READING: 6 Things to Look for in Quality Management System Software for the Pharmaceutical Industry

4. Improve Production Efficiency

It's no secret that your industry is under intense pressure to transform your operations. Even if you've been producing pharmaceuticals for generations, you have to find ways to reduce costs, add value, and turn your production into a competitive advantage.

You have to find innovative ways to be more efficient at manufacturing while still adhering to strict requirements from your regulatory bodies.

How to Achieve this Objective:

For decades, many pharma companies have had an almost adversarial relationship with the FDA and other regulatory agencies. Many of them have chosen to collect only the minimal amount of process data out of fear of what they'd reveal to the FDA auditors.

It's time to transform that line of thought and start thinking of the benefits of data collection and analysis in terms of production efficiency and cost reduction.

  • Instead of having humans weigh, dispense, blend, dry, mill, compact, coat, and package your productions, consider automating your processes. You'll have more data and tighter quality control on each stage.
  • Interface your disparate systems so they can share data and give you a more holistic view of your overall lifecycle.
  • Collect data electronically wherever possible. Paper-based data is inefficient and harder to utilize for more detailed analysis.

RELATED READING: The Perfect Quality Assurance Plan for Pharmaceutical Companies

5. Ensure Compliance

In the world of pharma compliance, there are no absolutes. The regulations that you need to comply with will vary depending on your phase.

For example, if you're in a pre-commercial phase, you will have to comply with FDA 21 CFR parts 50, 54, 56, 312, and 314. Your location will also impact your compliance requirements. If you're in the EU, you'll have to comply with EudraLex.

How to Achieve this Objective:

While specific requirements can vary by phase and location, there will be some essentials that will hold true across your industry.

  • You need to implement an eQMS to act as a comprehensive system of record.
  • You need to install a quality team in your company that is responsible for implementing and managing your quality system.

Compliance issues in the pharmaceutical industry are rarely the result of intentional misconduct. They usually are caused by broken workflows, simple human error, and a lack of collaboration. A manager may have forgotten to review a maintenance record after being out sick, or an employee is using an out-of-date SOP because they lost the updated one.

You can avoid many of these issues with increased visibility and an eQMS that is designed to support quality-driven operations.

The Qualio eQMS is designed to align with the latest FDA guidance. We offer easier compliance off-the-shelf and back it up with an expert support team.

Click here to schedule a demo and learn how Qualio can help you build a culture of quality and compliance.

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Find the cracks in your quality management processes.

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Published by Robert Fenton November 26, 2019
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Want to improve your quality managements?

Find the cracks in your quality management processes.

Take our interactive, 20-question self-assessment and quickly learn how to improve quality management.