If you are in charge of overseeing manufacturing operations or quality control, you know how much work is involved in making effective changes in the production process and product improvements. In many industries, including biotechnology, pharmaceuticals, cosmetics and food and drink industries, complying with good manufacturing practices (GMP) to maintain government certification requires diligent material testing.
Good Manufacturing Practices (GMP) are a set of mandates set by regulatory bodies, including the FDA hyperlink 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.
Maintaining GMP Certification through Challenges
When a GMP certified manufacturer encounters a product defect, they employ a variety of checks and tests to help find a solution. Material testing services help manufacturing companies throughout the various stages of production to overcome quality 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, LPC, GC/MS Analysis
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, GC/MS Analysis, Thermal Gravimetric Analysis
Having 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. Tell us about your issue and we can begin to work with you as soon as possible.