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Apr 01, 2021 Kelly Stanton

4 Major Quality Requirements for Pharmaceutical Companies

What major laws or regulations does my pharmaceutical organization need to follow?

As an industry-leading quality management system (QMS) provider, it’s something that we get asked all the time. 

Unfortunately, it’s a bit of a loaded question. 

Major regulatory bodies enact stringent laws and regulations to ensure that pharmaceutical products are built and distributed safely. These quality requirements for pharmaceutical companies underline the importance of quality, safety, and compliance.

In this article, we’ll highlight the major common good manufacturing practices (cGMP) for pharmaceutical companies. After reading, you’ll have all the information you need to take your product from ideation to creation and, ultimately, distribution.

Top 4 Regulatory Requirements for Pharmaceutical Companies

Before we begin, it is important to define cGMP in the pharmaceutical industry. According to the FDA, cGMP is defined as the “systems to assure proper design, monitoring, and control over manufacturing processes and facilities in pharma, and other FDA-regulated industries.” The sum of these systems creates high-value pharmaceutical products that are safe for widespread consumer use.

In short, cGMP helps pharmaceutical companies avoid major quality and compliance issues. For this reason, growing startups and scale-ups must view cGMP as a quality and compliance requirement. In turn, executive leadership must convey a culture of quality while simultaneously enforcing a strict quality policy.

Once you’ve adopted cGMP, here is a list of the major regulatory requirements for pharmaceutical companies that your organization must follow.

1. 21 CFR Part 314

The 21 CFR Part 314 regulation outlines the procedures and requirements for submitting an FDA application for a new product. Additionally, it outlines the exact process by which the FDA appropriately reviews and approves new applications.

Under 21 CFR Part 314 Sec. 2, the purpose is to “facilitate the approval of drugs shown to be safe and effective; and ensure the disapproval of drugs not shown to be safe and effective.” 

Moreover, it outlines the required documentation that pharmaceutical startups and scale-ups must supply in advance of the approval process. Unfortunately, failure to supply any of the required documents outlined in 21 CFR Part 314 will slow down the approval process. As a result, it will also inhibit product development and distribution.

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

2. 21 CFR Part 210

The 21 CFR Part 210 regulation outlines cGMP methods, facilities, and controls for the manufacture, processing, packing, and holding of a pharmaceutical product. An application and adherence to cGMP ensures that the product meets major safety and manufacturing requirements enforced by the FDA and other regulatory bodies.

Unfortunately, pharmaceutical companies that produce products that do not follow or comply with cGMP outlined in 21 CFR Part 210 are subject to regulatory action.

RELATED READING: What is cGMP in the Pharmaceutical Industry?

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3. 21 CFR Part 211

The 21 CFR Part 211 regulation outlines cGMP for product preparation — including requirements for personnel, buildings and facilities, equipment, product containers, packaging, laboratory controls, records, reporting, and more.

According to 21 CFR Part 211 Sec. 22, pharmaceutical companies are required to form a quality control unit responsible for “approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.” 

Moreover, members of the quality unit must engage in routine pharmaceutical quality training to ensure that they are able to fulfill the organization’s quality objectives.

RELATED READING: How to Pass Every Quality Management Audit Without Breaking a Sweat

4. 21 CFR Part 212

The 21 CFR Part 212 regulation outlines cGMP for positron emission tomography (PET) drugs. Specifically, it addresses the following PET focus areas:

  • Personnel and resources
  • Quality assurance
  • Facilities and equipment
  • Control of components, containers, and closures
  • Production and process controls
  • Laboratory controls
  • Finished drug product controls and acceptance
  • Packaging and labeling
  • Distribution
  • Complaint handling
  • Records

Unfortunately, those pharmaceutical organizations that fail to follow all PET cGMP outlined in 21 CFR Part 212 may face adverse regulatory action. 

RELATED READING: The 7 Fastest Ways to Fail an ISO Audit

How to Improve Quality within Your Pharmaceutical Startup

What is the best way to improve quality within your pharmaceutical startup? 

It starts with following the major laws and regulations outlined in this article. Secondly, it requires an investment in a best-in-class quality management system.

Qualio’s eQMS is purpose-built for growing startups and scale-ups. Our system helps your entire team document quality requirements and processes to ensure the development of a high-value product. 

Of course, if you’re building a pharmaceutical company from the ground up, this all probably sounds a bit overwhelming. To streamline the entire process, we recommend downloading our free guide: 12 Questions to Ask Before You Buy an eQMS

Read the guide to better understand the benefits and features you’ll get from investing in an industry-leading eQMS. By doing so, you’ll have all the information you need to make the right purchase for your growing company.

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Published by Kelly Stanton April 1, 2021