Product quality and safety is of the utmost importance for all manufacturers. Good, safe products are part of doing good business. But for manufacturers of products such as drugs, cosmetics, medical devices and some food items, ensuring product quality and safety is also part of compliance with Good Manufacturing Practice (GMP) standards.
GMP standards are a set of mandates set by regulatory bodies, including the Food & Drug Administration (FDA) and similar government organizations around the world, to ensure safety in products that are consumed and used in direct contact with people. A GMP badge on packaging, for example, implies that the regulatory agency has reviewed and approved the product’s manufacturing facility.
However, despite their best efforts, manufacturers do encounter quality issues and defects from time to time—and many of them turn to materials testing and analysis to find quick and accurate answers.
How Materials Testing Helps Maintain GMP Through Quality Challenges
When a GMP-certified manufacturer encounters a product defect, they employ a variety of checks and tests to help find a solution. Oftentimes, these companies turn to an experienced materials testing lab to support them throughout the production and quality control processes and to help identify issues and comply with GMP manufacturing regulations.
Hiring an outside laboratory that specializes in finding solutions to unique production challenges is helpful when internal resources are not sufficient or are simply too back logged to meet time constraints. Below is a description of how material testing methods can help a company comply with GMP throughout the research, development, and end user product testing cycles.
1. Research. Material testing can be used to measure the properties of potential components under environmental, production, and use scenarios. Reverse engineering of a competitor or vendor’s product is also a common application.
Testing methods include: FTIR analysis, GC/MS analysis, liquid particle counting
2. Development. If a challenge occurs while performing product testing during the development stage, cleanliness testing, materials characterization and other analytical techniques may help resolve the issue.
Testing methods include: Ion chromatography, Auger electron spectroscopy, scanning electron microscopy/energy dispersive x-ray spectroscopy
3. End-use testing. If failures occur during end use testing, material testing can determine if your product is faulty or if unanticipated environmental issues have caused the failure.
Testing methods include: FTIR analysis, GC/MS analysis, thermal gravimetric analysis
Are You Facing a GMP Product Testing Challenge?
When you encounter a disruptive challenge in your manufacturing operation, don’t let it bog you down. Innovatech Labs offers material testing services that help companies manage product testing challenges related to GMP and get them a solution with a fast turnaround time. Contact us about your issue and we can begin to work with you as soon as possible.