News & Events, Thought Leadership
Why Pharmaceutical Companies Should Start Changing Capsule Suppliers Now
Given the circumstances of the COVID-19 pandemic, many U.S.-based pharmaceutical manufacturers are suddenly faced with a hard truth: They have a supply chain problem. Specifically, they’re realizing that their existing overseas gelatin capsule supplier may not be able to continue to provide reliable production and delivery.
However, due to Food and Drug Administration (FDA) regulations, pharmaceutical companies cannot simply find a new supplier and quickly make the switch. There are specific procedures that must be followed, and these procedures can take time.
For this reason, pharmaceutical companies are advised to start changing capsule suppliers now—before supply chain disruptions adversely affect their production schedules. Or, at a minimum, get a secondary supplier through the approvals process and waiting in the wings.
Why should pharmaceutical companies be concerned?
There have always been inherent risks associated with reliance on an overseas capsule supplier. These include trade wars, political upheaval and quality control standards that do not meet the high bar set by the FDA. The COVID-19 pandemic has simply added additional risks: virus-induced population lockdowns, plant closures, border closures, bankruptcies and import delays caused by transportation sector disruptions. The global supply of gelatin capsules is tightening, and this alone gives pharmaceutical companies reason to be concerned.
Even if a capsule manufacturer is located in the U.S., pharmaceutical manufacturers must also look at where this supplier sources their raw materials, from the safety, quality and availability standpoints. Is the gelatin made from bovine hide or porcine hide? How much of their raw materials supply chain is under the capsule manufacturer’s control? And so forth.
How reliable is the current capsule supplier’s production? Having a safe and dependable source of raw materials is just “step one” in the production cycle. Pharmaceutical manufacturers must also be concerned with their supplier’s production capability, logistics, customer communications and ability to deliver product. It’s not enough to know that the supplier keeps an ample quantity of gelatin capsules in stock in the U.S. They also need to have an agile distribution system, so that they can quickly move capsules from their nearest distribution center to your manufacturing facility, or from one distribution center to another to accommodate an order from a new customer or an increase in demand from an existing customer.
The bottom line is this: When you need gelatin capsules, will your supplier be able to deliver?
What does the process of changing capsule supplier entail?
As a U.S-based drug product manufacturer, once you decide to supplement or change your gelatin capsule supplier(s), there are a number of steps that you must address. These include:
- Complete your standard supplier qualification process. Assess potential risks due to source, origin and use of capsule ingredients. Conduct an audit to verify that the manufacturing facility follows appropriate Current Good Manufacturing Practices (cGMPs) and all applicable regulations. Test samples from representative lots to confirm conformance to applicable specifications. You should also be sure that the new supplier is prepared to provide the required documentation to support your regulatory submission and satisfy any other requirements that your organization has.
- Request and review safety documentation. Verify process capability and confirm that the capsules meet your standards regarding BSE/TSE, residual solvents, and elemental impurities.
- Perform manufacturing trials. Confirm that the capsules from the new supplier run properly on your filling machines.
- Test the drug products made with these capsules. Verify that they meet specifications and are equivalent to the drug product made with the capsules from your current supplier.
- Determine if this is an annual reportable change or a Prior Approval Supplement (PAS). Provided there are no changes to capsule composition or appearance, including changes to size, color or dye, the addition of a new capsule supplier would be considered an “annual reportable change.” This would require a notification to the FDA stating that the change has been implemented to the drug product, but would not require additional FDA approvals.
However, if there will be a change in the capsule composition or appearance, or if you are changing from one type of capsule (such as gelatin) to another (such as HPMC), this would fall into the PAS category. In this situation, you will need to provide data that shows the equivalency and then obtain FDA approval before the change can be implemented.
Ideally, you will be able to avoid sourcing capsules that would result in a PAS, which will delay your ability to use the new capsules, versus purchasing capsules that simply result in an annual reportable change filing.
Conclusion
As you can see, changing capsule suppliers or adding a secondary supplier is a lengthy process. The time to get this process started is now—not three, six, or 12 months from now when you discover that the supply chain you thought was reliable is not.
