The weakest link
As we all know, the pharmaceutical industry is grounded in compliance. Approvals, certifications, locations. They all need to be provable and current. But it only takes one weak link, one small error, to turn a non-compliant ingredient (or supplier) into a liability.
And the more value that has been added to an ingredient through processing at your end, the more you, as a manufacturer, have to lose.
But where is the weakest link? Who is ultimately responsible for ensuring an ingredient is up to scratch before moving it from the inwards goods dock to your warehouse, and then to your production line? And who makes sure that supplier certifications are current?
It is not your supplier’s responsibility, or even theirs. It’s yours.
Owning the problem
Spot quality checks on inward goods for compliance are essential. While frustrating, common sense dictates that testing regimes are critical, no matter how reliable and trusted the supplier. There is no grey area between an ingredient passing the quality and compliance requirements or not. It’s stop or go.
In theory, best practice minimises these issues. You do regular testing. You only ever purchase from suppliers who are on the national certification register. You never move inward goods from the warehouse until they are quality approved.
But how do you stop ‘accidents’ from happening when you are dealing with so many variables?
With today’s uncertain supply chain, how confident are you that expiry dates or quality variations for raw materials are within your accepted limits? If you need to purchase a substitute ingredient from a new certified supplier, will it always be subject to testing at your end? And how do you stop unscreened product from being released from your warehouse to your production line?
A testing time
If you are not using industry-specific applications to give you the control you need, you are always going to be subject to the costly consequences of human error.
What should you expect from your application? At a minimum, three functions are non-negotiable.
- Let’s start with approved vendor capability. This allows you to manage the vendor approval process per item with effective and expiration dates per item to ensure proper screening and compliance.
- Then, there’s electronic quarantines to ensure that inward goods which haven’t been quality tested are ringfenced until officially approved. This way, they cannot be introduced to your production line by accident. Only once tested are they electronically stamped as approved, and will get the green light when scanned.
- And critically, is a controlled testing regime which dictates what percentage of the ingredient must be tested (for example, one box out of every 100). And if wished, even blocks payment of a supplier’s invoice until it’s approved. While you doubtless have a stringent quality control already in place, full integration with finance, warehousing and quality control streamlines the entire process.
Today’s technologies are designed to enforce good practice. If you are still relying on manual processes, you are not only creating more work, but enabling errors. And in this business, that’s just bad medicine.
