Quality assurance and control are essential for biotech and medtech startups.
Although the terms are sometimes used interchangeably, quality assurance and quality control are actually two different pieces of a complete quality management program.
Quality assurance consists of the policies and procedures that are implemented before or during production that help prevent problems with the finished product. In terms of FDA requirements, a problem is any deviation in processes or products. To assure the quality of a product, tools such as documentation, checklists, certificates of analysis, and validations can all play roles. The over-arching goal of quality assurance is to prevent product defects.
One example of quality assurance playing a role in a process would be a technician completing a checklist as they go, helping to ensure that all steps of the procedure were completed. The technician would also note any irregularities in the process, and depending on the severity, may pull the product out of production due to a deviation in process.
Whereas quality assurance involves prevention, quality control is about detecting defects and deviations. Quality control means testing the processes involved in creating a product and testing the product itself to ensure that the correct parameters are met.
Testing whether a product’s coating is the correct thickness would be an example of quality control. If the answer is no, the product would not be sold and an investigation would determine the cause of the incorrect thickness.
In regulatory affairs, there is a saying: “If it’s not documented, it didn’t happen.” In the context of producing FDA-regulated products, that means that every step in the development and manufacturing processes needs to be documented. Without such documentation, a startup might find out that their work has to be repeated in order to be valid in the eyes of the FDA.
Currently, many startups still use paper lab notebooks, which make accurate data collection and storage difficult. There are areas in the laboratory in which it is not ideal to bring a lab notebook, so scientists resort to taking notes on paper towels, lab wipes, and the backs of their gloves. Then they take these notes and transfer them to lab notebooks, sometimes hours after they have finished the procedure. As many people remember from school, notes that once made complete sense can lose their meaning entirely after a relatively short time, so record keeping that isn’t immediate and complete can be a place where errors are made. Additionally, a lab notebook has no way to automatically record the time when the notes were entered. Edits made after the fact may look like notes that were included in the first draft unless they are properly annotated. Essentially, paper records allow for too many instances of human error to constitute sufficient record keeping in a highly regulated industry.
The solution to this is to institute a quality management system with processes that require and facilitate accurate, timely, and secure record keeping. Most often this involves a digital system that time-stamps all entries, and policies that require scientists to enter information within a certain time frame after an experiment.
Quality management systems are expensive, which explains why many startups don’t use them. However, their cost pales in comparison with having to repeat experiments or losing out on potential investors who recognize the lack of quality management. Good quality management means good regulatory compliance.
The flip side of this is, a quality management system that was built for a large company is not necessarily a good idea for a startup to use. There are companies that provide quality management software for smaller companies and consultants who can help startups determine what they need at this point and what can be implemented later.
For a startup that has chosen to develop a quality management program, it is ideal to understand the FDA’s requirements for such an endeavor. As biotechnology and medical device products are regulated by different parts of the FDA, they have different regulations and guidance documents. This discussion will cover each in turn.
Biotech and pharma companies are regulated under 21 CFR part 210 and 211, the documents covering good manufacturing practices for these industries. For quality systems specifically, the FDA has issued multiple guidance documents. These are generally authored and utilized by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), so they apply to both biologics and pharmaceuticals. In 2009 the FDA released a guidance document covering ICH Q10, an internationally recognized comprehensive model for a good quality management system.
This document describes a set of requirements for a complete quality management program/system. They include:
Medical devices are regulated differently depending on their class, which generally relates to the risk level conferred by the device. The “riskiest” devices require premarket approval and this discussion will cover FDA guidance on quality systems for premarket approval applications. In 2003 the FDA released a guidance document on the quality system information that must be submitted as part of a premarket approval application. This includes:
Understanding the essence of what the FDA is looking for when it comes to quality is important, but how exactly should startup biotech and medtech companies choose a system? Here are six components that make up a useful electronic quality management system:
Although quality systems seem cumbersome, expensive to implement, and aren’t strictly required for an early stage company, there is agreement among many investors, regulatory experts, and experienced startup CEO’s that they are necessary. Rather than waiting to consider quality management until the last minute, adopting even some of the concepts and practices outlined here can help biotech and medtech startups avoid expense and lost time down the road.
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