Good Manufacturing Practice
Good Manufacturing Practice (GMP) refers to a set of regulations the Food and Drug Administration (FDA) uses to carry out effective oversight of medical device companies. GMP helps to ensure safety and efficacy in medical device development and manufacturing by creating a uniform standard for medical device companies to uphold. The regulation itself is created through a dialogue between the business and the FDA.
There is a common misconception that GMP directly applies to achieving FDA clearance on a medical device. In truth, GMP applies to the mechanisms and workflow of a company and helps to ensure that a company is following their own rules. Writing operating procedures for oneself is an act of self-government, which is why we sometimes like to refer to this as “local law.” The workflow that one medical device company outlines may not directly match the process or needs of another, and that’s alright.
When discussing GMP you might hear a variety of terms that mean the same thing, including:
● Current Good Medical Practice (cGMP)
● Quality Systems Regulations (QSR)
Each of these terms refer to the same part of the FDA regulations.
According to 21 CFR Part 820.1, a section of Subpart A, GMP applies to “…the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” What really matters here is the phrase ‘intended for human use.’
If a medical device or product is being developed with no intention of human use, it is not governed by GMP. Similarly, companies that manufacture components of a device are not necessarily responsible for following these guidelines. The business that is offering the device to the market is responsible for compliance with GMP.
The main goal of GMP is to regulate the production of medical devices that are intended for human use.. “The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act” (21 CFR Part 820.1). GMP applies to every step of the process from design to manufacturing. To do this properly, we at in2being break it down into three main sections:
● Management and oversight
● Design and document control
● Manufacturing and fulfillment
For help on determining who needs to worry about what, and how to collect the right information, it’s beneficial to leverage your design partner, or find a design partner familiar with these regulations. Regulatory experts here at in2being can help ensure the right procedures end up in the right place.
Management and Oversight
Subpart B of 21 CFR Part 820 pertains to the responsibilities of the medical device company. Within this subpart companies are expected to include policies and processes that apply to their management oversight. The company must detail their commitment to quality, how they plan to achieve that quality, and how they are organized to do so. This includes information such as:
● Proof of sufficient personnel to carry out the development.
● The specific training and education that will be required of and for involved personnel.
● Organizational structure of employee dynamics (who is in charge, who is responsible for what).
● Proof of a review process in which management oversees the quality standards are being met.
● Procedures for audits that can be carried out by individuals who are not directly responsible for the product development to confirm compliance with the quality policies.
Design and Document Controls
The next portion of regulations, Subparts C & D, apply to the company that builds the medical device. This can be the startup itself, but could also be satisfied by a development firm brought in for technical assistance and product development. These subparts focus on ensuring that each step of the development and design process are adequately planned and documented. The two sections are as follows:
● (C) Design Controls — These regulations pertain to the development planning, inputs and outputs, design review, etc. Design controls help developers stay on the right track during product development.
● (D) Document Controls — Documentation must be available at all locations where needed and include all necessary information. Obsolete documents should be removed so that a file is up to date. This section also requires procedures for document changes and approval by designated individuals.
It’s worth noting that individual companies must only comply with GMP for the processes in which they are involved.
Manufacturing and Fulfillment
The third portion subparts have to do with the production and distribution of the medical device. Once again, the startup can handle these aspects, but typically work with a manufacturing firm. Leveraging the manufacturing firm to comply with GMP can ease some of the labor for a startup, but they should still make sure to work with the firm to avoid any confusion.
Manufacturing and fulfillment controls include procedures for packaging, dealing with defective products, guidelines for production, how to handle/store products, and other aspects of building and transporting the medical device. Subparts E-O all fit into this category, those subparts are:
● (E) Purchasing Controls
● (F) Identification and Traceability
● (G) Production and Process Controls
● (H) Acceptance Activities
● (I) Nonconforming Product
● (J) Corrective and Preventive Action
● (K) Labeling and Packaging Control
● (L) Handling, Storage, Distribution, and Installation
● (M) Records
● (N) Servicing
● (O) Statistical Techniques
In total, 21 CFR Part 820 has 15 subparts (A-O) that regulate device activities, supplier controls, and many other aspects of GMP compliance.
Although there is no earned approval or certification for GMP, the FDA does double-check to confirm that your company is following the rules and regulations it wrote for itself. At some point during your company’s life, the FDA is likely to notify you that they are stopping in to perform an audit. This means they will compare what’s happening in your company to what was written in your quality manual. Confirming certain written procedures, testing personnel on the knowledge they’re claimed to possess, and asking for documentation. As long as you’re able to supply the things that they ask for, proving you follow your own “local law,” there won’t be any issues.
If the FDA finds a discrepancy between the quality manual and the real-world development, they will work with you to ensure the problem is fixed. Ultimately, their goal is to ensure that you provide a safe and effective product to the market.
With years of experience in the medical device development industry, the team of experts at in2being have the knowledge and skills to guide you through the GMP process. Our regulatory veterans can assist you in the interpretation of GMP compliance requirements and work with you to design an optimized product. The developers at in2being use a holistic approach; the whole team works together. Product designers are in constant conversation with the inventor, the manufacturers, and marketing specialists, striving for a desirable outcome. This ongoing communication guarantees that everyone is on the same page and has the same goal.
Whether you have a device and you’re struggling to comply with FDA GMP regulations, or simply have an idea that you’d like to bring to life, reach out to in2being today.