Quality beyond GMPs

Good Manufacturing Practices (GMPs) for midsize manufacturers kick in today, upping the ante in the quality-control game. Beyond GMPs, however, a recent government partnership with private industry is helping maintain supply-chain integrity for those companies importing and exporting ingredients.

Called the Customs Trade Partnership Against Terrorism (C-TPAT), a few suppliers have signed on board, and soon the programme will be just another part of every company's QA/QC efforts.

"A lot of companies don't know about it but in the near future it will be a mandatory programme, not something you opt to do," said Jean Trimbo, purchasing manager for Integrity Nutritionals, which supplies the CinnulinPF cinnamon ingredient and also is a distributor and contract manufacturer that works worldwide. "We might have seen greater delays importing into the country had we not been enrolled."

That is part of the bargain. "The risk of supply-chain disruptions, and an increased number of customs inspections resulting from noncompliance with C-TPAT, is simply cost prohibitive. Border delays cost money," noted an FDA release. "Moreover, without certification, a company is not eligible for benefit programs such as the Importer Self-Assessment (ISA) program, and more and more companies insist upon doing business only with C-TPAT certified companies. C-TPAT is simply an industry standard at this point."

Companies signing on are demonstrating a desire to maintain rigorous supply-chain security, while also benefiting from priority processing at the border, minimizing the potential for delays that can create problems, financial hardships and time-to-market issues.

"Through the program, we make sure we audit all our supply, their processes, educating suppliers on the security that's necessary," said Trimbo. "Customs would like us to do audits overseas and if we don't do them, they'd like us to do third-party audits."

She said the process was time consuming and you must get the buy-in of all your vendors. But the extra steps to vouchsafe the integrity of their ingredients is a smart move for the company.

"It played into our agenda of how we wanted to conduct business. When we are looking for new vendors we reject a lot because the C of A (Certificate of Analysis) doesn't match what the product tests out at. It's one of the primary reasons we opted to go into the programme, and also why we test every ingredient we get — to make sure it meets our specs and it's safe."

For more on supply-chain security in the age of agroterrorism, check out this Rand research brief and this presentation from the Third International Symposium on Agroterrorism.

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