The FDA maintains the Good Manufacturing Practices (GMP) Standard for companies manufacturing medical devices, pharmaceutical, biotechnology, and other healthcare related products. The GMP standard is the foundation for quality control and product safety in the United States.
FDA approved labels cover a wide range of activity within the healthcare industry, from internal operations and quality status identification to end user facing product labels. While GMP Labeling Inc. can support clients with all aspects of FDA compliance labels, this article contains information specific to labeling for internal quality control operations.
What standards apply for internal Quality Control Labels?
A critical component of both maintaining Quality Control and meeting regulatory requirements is the proper use of labels throughout the manufacturing process. Labels are used to identify a material, component or product as well as communicate the status and pertinent information of the labeled object. GMP Regulations and ISO 9001 standards cover a range of areas regarding internal quality control labels, including the calibration status of measurement equipment, the control of materials and components, and the final inspection of finished products.
Proper identification and labeling in your internal operation ensures that components and products follow your procedures and that operators and technicians can easily identify the quality status of a product in order to determine its disposition.
GMP Standards or Medical Devices (21 CFR, Part 820)
- Part 820.61 - Measurement Equipment - “calibration date, the calibrator, and the next calibration date shall be displayed…” - this standard requires that any device requiring calibration will be labeled with information regarding the past calibration and future events.
- Part 820.80 - Components - “identification shall be easily viewable. All obsolete, rejected components shall be clearly identified…” - this standard requires that parts, materials, and components that are used in the manufacturing of medical devices are labeled with information communicating the quality status as well as component identifying information such as part number, lot number, etc.
- Part 820.160 - Finished Device Inspection - “shall be held or otherwise adequately controlled until release…” - this standard requires that finished devices are controlled until they pass inspection. A method of control is to label a device in such a way that devices awaiting inspection are identified as “On Hold”, “In Process”, etc. and devices that have been inspected are labeled as “Approved”, “Released” or “Rejected”
ISO 9001 Standards
- Part 4.11 - Inspection, Measuring, and Test Equipment - “Identify, calibrate, and adjust all equipment at prescribed intervals…” This part requires that any equipment used in inspections and measurements are calibrated at regular intervals. In order to ensure that equipment is calibrated within the proper internal, a label can be used to identify the last calibration date and the next scheduled calibration.
- Part 4.10.2 - In Process, Inspection, and Testing - “identify product as required by the procedures…” This standard requires that any component or product is identifiable and communicates its current quality status.
- Part 4.12 - Inspection and Test Status - “status of product shall be identified by using markings, stamps, tags, and labels…” The crux of the labeling standard, this part requires that all products and components have something to identify its status, including “In Process”, “On Test”, “Quarantine”, “Approved”, “Released”, “Rejected”, and “Calibrated.”
What labels do I need to maintain FDA Compliance?
Our portfolio of products was purposefully made to easily comply with regulatory requirements and implement in your operation. Whether you are launching a new site and are brand new to GMP requirements or you are a seasoned Quality Manager, the summary of our compliance labels will help guide you through exactly what you need to meet FDA regulations.
Calibration Labels
Our calibration labels will help you: maintain test equipment, identify status, and comply with Part 820.61 of the GMP Standard. These labels contain fields for writing important information and can be manufactured with a self-lamination, protecting this written information from smearing or damage.
Quarantine and In Process Labels
Our Quarantine and In Process Labels are used to identify components and products that are not finished, have yet to be inspected, or require additional disposition from a quality control technician. These labels help you comply with ISO 9001 Section 4.10.2. The labels are designed with a large header communicating the quality status, additional fields for writing critical information, and are color coded for quick identification.
Approved Labels
Our Quality Control Approved labels are made with a bright green fluorescent facestock to quickly and easily identify components and products that have passed an inspection and are approved for either internal use or for distribution to customers. We have a variety of labels with words that match your procedures, such as “Approved”, “Accepted”, “Released”, etc. These labels help you meet a number of regulatory requirements, including GMP 21 CFR, Part 820.80; GMP 21 CFR, Part 820.160; and ISO 9001 Section 4.12.
Rejected Labels
Our Quality Control Rejected labels are made with a bright red fluorescent facestock to quickly and easily identify components and products that have failed inspection and require rework, disposal, or some other disposition. Ensure that these components and products that fail your Quality Standards do not make their way through manufacturing or distribution with these rejected labels. These labels help you meet a number of regulatory requirements, including GMP 21 CFR, Part 820.80; GMP 21 CFR, Part 820.160; and ISO 9001 Section 4.12.
Not for Human Use, Research Only, and Not for Clinical Labels
Our Caution Labels can be used to communicate a wide range of cautionary statements to ensure that finished products are not unintentionally used in the wrong way. Products can be labeled as “Not for Human Use” to ensure that products are not used for humans. We have labels ensuring that products that are not FDA Approved but still can be used for research and investigations, including “For Research Only” and “Not for Clinical Use” Labels. View our entire portfolio of Caution Labels.
Experts in Compliance Labels
With GMP Labeling Inc. as your label compliance partner, you can rest assured that your quality control operations will meet FDA regulatory requirements and help you pass any future audits. Since 1987, GMP Labeling Inc. has been serving clients regulated by GMP standards and is an industry leader for product identification and label compliance. If you can’t find a stock label that meets your needs, reach out to us and learn more about how we can create a custom label specific to your operation.
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