Dec 19, 2019 Robert Fenton

Understanding the Scope of Quality Assurance in the Pharmaceutical Industry

Stressing the importance and scope of quality assurance throughout a pharmaceutical organization can be a challenge. When you have something that has the potential to drastically change lives, it can be hard not to do everything you can to get it to market quickly.

However, it's important that everyone in your company knows how crucial quality is to you and your customers.

The pharmaceutical industry learned this hard lesson during the thalidomide disaster of the late 1950s. Thalidomide was given to pregnant mothers in the first trimester to help with morning sickness, and, as a result, 123,000 babies died in the womb, and over 24,000 children were born with thalidomide-related disabilities around the world.

The US was spared from the worst of the disaster because FDA inspector Frances Kelsey was not satisfied that it was safe. She refused to approve the drug for use in the US and persisted in requesting additional clinical trial data and information.

Thousands were devastated by thalidomide. Drug companies learned how important quality in manufacturing is, and Kelsey's persistence laid the groundwork for more rigorous drug approval regulations worldwide.

You can do your part to avoid another disaster by having a good understanding of the scope of quality assurance (QA) in the pharmaceutical industry. Ensure that your team understands your QA unit's responsibilities and expectations and that they work well with all branches of your business.

What Is the Scope of Quality Assurance in the Pharmaceutical Industry?

Quality assurance is a pretty broad concept. It covers all aspects of your process that can have an impact on patient outcomes.

The risk of not implementing a comprehensive quality system is well-documented. Most outcomes of poor quality won't be as severe as the thalidomide disaster, but they can still be devastating to your company.

You could incur substantial costs internally related to remediation and product failures. You also could face external costs like regulatory action, reputational damage, and a loss of market share.

One academic study found that QA failures can cost a business over $100 million, and for the small percentage of Big Pharma firms that face litigation, the costs can exceed $1 billion.

It's time to craft a plan for quality assurance in every phase of your pharmaceutical product lifecycle.

Quality Assurance Touches Every Phase of the Product Lifecycle

QA is involved in the planning, system governance, and process of every phase of the pharmaceutical business. Your quality team is responsible for defining and executing systems and processes across your company that ensure your goods and services meet all quality, efficacy, and safety requirements.

QA should be involved in every one of these phases:

  • New Product Planning
  • Design
  • Prototype Creation
  • Testing
  • Subcontracting
  • Purchasing
  • Process Design
  • Trial Production
  • Production
  • Marketing
  • Distribution
  • After-Sales ServiceNew call-to-action

Create a Quality Assurance Plan

A Quality Assurance Plan will help you provide a foundation for compliant manufacturing systems. It defines how each process should work as well as how each subsystem should integrate to help you consistently produce quality pharmaceuticals.

Your plan should include seven main components:

  1. Document Control
  2. Training
  3. Deviation
  4. Laboratory OOS (Out of Spec)
  5. CAPA
  6. Internal Audits
  7. Management Review

Related Reading: The Pharmaceutical Guide to the Perfect Quality Assurance Plan

Build a Culture of Continuous Improvement

Consistently manufacturing the highest quality pharmaceuticals isn't going be a one-time goal. You won't simply be able to create a plan, implement it, and then achieve lasting results.

You will need to implement a culture of continuous improvement throughout your company — from the management team down to the shop floor.

Continuous improvement allows you to regularly assess your systems, find the flaws, and build a plan for correcting them. You can identify quality issues before they impact your company and find ways to reduce costs and increase production.

Related Reading: 4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

The Role of an eQMS in Quality Assurance for Pharmaceuticals

Achieving quality excellence is critical for your company's success and the public's safety. Maintaining compliance 24/7/365 can be challenging — but it's necessary.

A thorough understanding of the scope of quality assurance must be an integral part of your day-to-day systems and a priority for your team. From designers to sales and marketing, everyone needs to understand the importance and work towards a quality compliance goal.

Audit-ready compliance is easier to achieve when you implement an Enterprise Quality Management System (eQMS) that is easy-to-use and brings all of your paper-based and disparate systems into one platform.

You can manage every aspect of your project in one software package:

  • Document tracking
  • Approvals
  • Revision Management
  • Training Programs
  • Approved Suppliers
  • and a lot more

At Qualio, we help teams bring high-quality, life-saving products to market. We've created a sophisticated, secure, and easy-to-learn quality management platform specifically for growing life sciences companies.

Schedule a Personalized Demo today, and we can show you how Qualio's eQMS software can help you implement a culture of quality across your entire company.


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Published by Robert Fenton December 19, 2019