Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

In recent years, the biopharmaceutical industry has experienced an onslaught of regulatory changes. 

When you consider the total volume of regulatory changes, it can be difficult to know which laws your biopharma startup needs to comply with.

In most cases, the caliber of your quality management system (QMS) will make or break your compliance efforts. Additionally, routine consultation of FDA 21 CFR will help to ensure that your product complies with major safety, efficacy, and security requirements.

The list of biopharma requirements is substantial. However, these requirements are well-documented and manageable as long as you identify, develop, and implement a deliberate quality management and compliance program.

By following the five steps of biopharma quality management outlined in this article, you’ll have the information needed to mitigate compliance risks, maintain good manufacturing processes, and streamline your path to rapid FDA approval.

How to Activate Effective Biopharma Quality Management in 5 Simple Steps

The steps to ensure quality and compliance within a biopharma company are not that different from other industries. However, the regulatory requirements unique to the pharmaceutical industry can be much more demanding.

Follow the five steps below to make sure that you’re checking the right boxes on your path toward effective biopharma quality management.

1. Identify and Understand the Regulations

Start by pinpointing the unique classification that your product falls under as outlined in Title 21 of the Code of Federal Regulations (CFR). 

Typically, product classification depends on the type of product as well as its intended use. For top-line information related to pharmaceutical laws and regulations, consult Part 200: “General".

Additionally, we recommend reviewing Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals.” 

Unfortunately, failure to comply with major manufacturing principles may result in the untimely suspension of your product.

2. Align Your Team on the Requirements 

Next, create a regulatory register tailored to your unique organization. 

Using FDA CFR 21 as a guideline, clearly define all applicable regulatory categories and then narrow it down to specific requirements. Be proactive when it comes to compliance and make sure that your team is always on the same page. 

In addition, you should also identify and collect best practices related to document management, quality assurance, and manufacturing. Share these insights with your team for successful adoption.

3. Organize a Compliance Risk Management Team 

Assigning ownership of specific compliance tasks to individual team members can cultivate team ownership of the compliance process. 

Identify your major risks and prevent penalties by performing routine compliance risk assessments. Keep up to date on changing laws and plan for regulatory changes and how the team should adapt to them.

4. Use a Process Map to Organize Internal Workflow

A process map is a visual planning tool used to detail a flow or direction of your work. 

By utilizing process mapping software, you’ll have the visual framework for procedures required to produce favorable quality management results. These types of flowcharts should clearly show who and what is involved in the process and preventatively flag areas where corrective and preventative actions (CAPA) may be needed.

Of course, the simplest option is to draw your process map on a piece of paper. 

This option works in a pinch. But it also comes with major downsides. For example, you can’t share it with team members for further review or discussion.

The superior option is a digital workflow system. 

In most cases, QMS vendors offer simple workflow automation solutions designed to orchestrate the effective and rapid flow of quality management information from one stakeholder to another.

5. Utilize a Quality Management System

Today, investing in an electronic quality management system (eQMS) is the best way to stay on top of regulatory compliance and biopharma quality management. Simply input your workflow into the software, and the system will automatically facilitate its execution. For the best results, keep your steps and plans as simple as possible. 

You’ll also want to be sure to consult ISO 9001. 

This standard helps organizations ensure they are complying with statutory and regulatory requirements relating to their products and services.

As such, ISO guidelines bring into focus the effective implementation of quality processes and standard operating procedures (SOPs). Maintain ISO 9001 certification to stay on top of industry trends related to quality management and avoid potent hazards on your path to rapid eQMS adoption.

Finally, make sure that your software is lean, easily configurable, and integrated with your unique quality management processes and systems. 

The right eQMS should provide clear resolution and trend visualization. Additionally, you’ll need a system that can easily organize audit requests as your product approaches pre-market approval.

Getting Started with the Qualio eQMS 

How does your current QMS rank in terms of ease of use, administration, compliance, implementation, and adoption? 

If you answered “not so great,” maybe it’s time to consider an effective alternative.

We might be a bit biased, but Qualio did score top marks in QMS Usability, Implementation, and Satisfaction.

“Rankings on G2 reports are based on data provided to us by real users,” says G2 Chief Research Officer Michael Fauscette. “We are excited to share the achievements of the products ranked on our site because they represent the voice of the user and other terrific insights to potential buyers around the world.”

Is Qualio right for your unique biopharma startup? 

To answer this question, schedule a free demo today. 

During this demonstration, you’ll have a hands-on opportunity to review the Qualio eQMS. Use this time to ask questions related to your specific use case and product to help you determine whether Qualio makes sense for your organization’s unique needs.

Here’s to achieving regulatory compliance!