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Apr 06, 2021 Kelly Stanton

How to Master Pharmaceutical QA in 4 Simple Steps

What does it take to master pharmaceutical quality assurance (QA)?

The most successful pharmaceutical startups know that QA refers to anything that might affect the quality of a drug during all lifecycle stages, including research, manufacturing, sales, and marketing. QA professionals are responsible for instituting a range of quality measures to ensure that products meet regulatory requirements.

Depending on the maturity of your pharmaceutical startup or scale-up, building a robust QA plan is easier said than done. Moreover, it can be difficult to know what steps your organization needs to follow to master QA. As an industry-leading quality management system (QMS) provider, we’ve seen it all when it comes to QA.

This article provides a step-by-step process to streamline pharmaceutical QA. In this way, you’ll have everything you need to build a culture of quality within your growing pharmaceutical startup or scale-up.

Follow These 4 Steps to Master Pharmaceutical QA

Before we begin, it’s important to ask the following question: Why is QA important for pharmaceutical companies? 

For starters, QA is critical in maintaining a positive reputation and building consumer confidence. Unfortunately, QA failures result in serious regulatory infractions. As such, mistakes in pharmaceutical manufacturing, packaging, and product testing are targets for national news.

What’s more, governing bodies such as the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Office of National Drug Control Policy (ONDCP) require organizations to think critically about QA through the enforcement of strict regulatory laws and regulations. 

For example, Title 21 of the Code of Federal Regulations outlines major manufacturing standards. Unfortunately, violating or operating outside of cGMP can result in severe regulatory action.

We recommend investing in a QMS to streamline pharmaceutical QA. In most cases, a robust QMS can even automate pharmaceutical QA. 

Additionally, we recommend following these four results-driven steps to master QA within your organization.

Step 1: Plan

To start, your organization should plan and establish processes required to deliver an effective and safe product. The importance of planning cannot be overstated.

There are five essential objectives of pharmaceutical QA programs, including protecting the public, building consumer confidence, activating negative publicity safeguards, improving production efficiency, and ensuring regulatory compliance.

The most important goal of the planning phase is to focus efforts on protecting the consumer. As such, keep users’ unique wants and needs in mind during the manufacturing and production process. For the best results, we recommend committing to ongoing regulatory training to reinforce the importance of consumer-product health and safety.

RELATED READING: 5 Objectives of Quality Assurance in the Pharmaceutical Industry

Step 2: Do

When the rubber hits the road, the “do” step requires your organization to activate processes to secure QA objectives. 

In this phase, it may be best to start small and scale as you go. For example, you may encounter unforeseen obstacles during production. This is far easier to do with a small team. 

Secondly, your team will benefit from increased speed, ideation, and flexibility. In this scenario, activating the QA program in one area of the organization first is faster. And it decreases onboarding time. 

At this point, once you’ve built confidence in your QA program, you can start to introduce it to other parts of the organization.

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Step 3: Check

In this phase, it’s important to monitor and modify QA processes in pursuit of QA objectives. Do these processes align with QA goals? The “check” phase is one of the most vital steps that most growing pharmaceutical startups ignore.

By committing to routine maintenance, your startup can proactively identify areas of friction. Additionally, it will help you to avoid recurring mistakes. 

Here, you must audit QA processes and work to mitigate problem areas. Analyze anything that isn’t performing as expected and activate corrective and preventative responses.

RELATED READING: The 8 Essential Functions of CAPA Management Software

Step 4: Act

Finally, leverage the expertise of an internal quality assurance tester to institute the necessary actions needed to improve areas of the QA process. For the best results, findings made during the previous phase must be communicated to the QA professional.

After this step is complete, you should have a results-driven pharmaceutical quality assurance program prepared for the entire organization. 

However, the plan-do-check-act cycle is not a once-and-done activity. Instead, your team should commit to ongoing improvements to QA. 

In fact, ongoing QA maintenance is the first step toward building a culture of quality within your startup or scale-up.

Master Pharmaceutical QA with Qualio

What are you doing right now to build a quality-driven culture?

Qualio’s QMS is designed to instill a quality-first mindset within your organization. Our product helps your entire team document and manage quality requirements and processes to ensure a safe and effective product. 

Additionally, our software enables QA professionals to easily store and manage quality documents.

 

Does our all-in-one eQMS make sense for your growing pharmaceutical startup? 

To find out, download our free guide: 12 Questions to Ask Before You Buy an eQMS. Read it to learn more about the top features of a results-driven eQMS and the questions you should ask prospective eQMS vendors.

Don’t make a blind investment! Instead, download this guide and arm yourself with the insider intelligence you need to make an informed purchase for your startup.

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Published by Kelly Stanton April 6, 2021