Good manufacturing practice (GMP) is a regulatory framework to ensure food, pharmaceutical, medical and cosmetic products are consistently produced to quality standards appropriate for their intended use and product specifications.
Importers must regularly audit their foreign supplier’s quality management system to verify GMP compliance. Without this assurance of GMP compliance, your importing business is at risk of product safety issues, product recalls and even criminal prosecution by regulatory authorities.
Also known as “mock audits”, InTouch’s GMP pre-audits mimic EU and U.S. FDA inspection protocols to help you and your suppliers prepare for an official GMP audit. InTouch can perform GMP audits for suppliers of the following product types:
Our audits typically last one to two days and include:
After the audit is complete, you’ll receive a detailed report including:
Many factories don’t have qualified management with the discipline and background needed to implement, maintain and monitor a GMP-compliant quality management system.
In China, most factories aren’t well-versed in the specific GMP regulations of their buyer’s target markets. Nor do local laws or regulatory bodies hold factories accountable to international requirements.
As an importer, it’s your responsibility to educate your foreign suppliers on GMP regulations. But without a full-time team on the ground, it can be hard to push for changes at your supplier’s facilities.
That’s where InTouch can help. Through our GMP compliance training program, our auditors will regularly meet with your supplier to help them better understand GMP requirements and pass an official GMP audit.
Our GMP compliance training program includes the development of a corrective and preventative action (CAPA) plan to address GMP violations. After developing the CAPA plan, we’ll re-audit your supplier as needed to assess the implementation and effectiveness of their improvements.
Don’t settle for a third-party auditing provider who lacks expertise in GMP regulations and fails to comprehensively assess your supplier’s FDA inspection readiness.
InTouch pairs international GMP expertise with extensive local knowledge to help both you and your foreign suppliers prepare for an official FDA inspection.
If you’re ready to talk to us about verifying a foreign supplier’s GMP compliance, click the button below or fill out the form on the right to contact us now.
You guys are quite efficient in making sure that you are in constant communication with our vendors to set up a time and day to have inspections handled... InTouch definitely pushed to make sure that inspections would be done in a timely manner. Any corrective actions that had to take place were executed well before the exit factory date.
Director of Production, Betabrand
Since InTouch does a more detailed inspection than what we had depended on with the factories, the quality of the products has improved. Where before when we might find 25 AQL defects, now it's down to three or four,because the factory knows that we want that cut back and InTouch is going to find it.
Administrative Assistant, Linstol
One of our customers had been through multiple suppliers year after year and had been let down with returns and rejections. With InTouch as our eyes and ears on the ground, we retained that business for 5 years without one single rejection or complaint.
Director of Operations, MMI Textiles