Q: What is the U.S. Food & Drug Administration looking for in regard to packaging machine validation/qualification?
A: The FDA is looking for proof that the company is in control of its processes and stays within its planned limits. They want to know what happens if, for example, the amount of the fill is out of the accepted range. What is the corrective action? Every pharmaceutical firm has its own way of putting together a plan. We stay attuned to the FDA's requirements.
Q: Are pharma companies demanding more from machine controls today than in years past?
A: Companies are trying to rely less on the human factor for documentation to reduce errors. That's where they're asking more from automation. Meeting CFR21 requirements means that recordkeeping can't be altered. With SCADA and overall data acquisition systems creating considerable documentation, and with different control systems sometimes on each piece of equipment, the interface to that data becomes more challenging, and companies are beginning to dictate to us what control packages they want to consistently collect the necessary data.
Q: In some industries, competitive firms will help one another when it comes to packaging machinery. As you see it, is this the case in the pharmaceutical arena?
A: If you're talking about the drugs and formulas, no. But on the equipment side, we find it's more of a plant-to-plant issue rather than company to company. If one firm's plant is producing insulin, and another company's plant makes insulin, they won't talk, but if they make different products there's some openness. A pharmaceutical customer can talk with another pharmaceutical company that's already using our equipment. It's a good selling tool for us, and it helps them to evaluate the equipment and controls.
--By Jim Butschli, Editor
A: The FDA is looking for proof that the company is in control of its processes and stays within its planned limits. They want to know what happens if, for example, the amount of the fill is out of the accepted range. What is the corrective action? Every pharmaceutical firm has its own way of putting together a plan. We stay attuned to the FDA's requirements.
Q: Are pharma companies demanding more from machine controls today than in years past?
A: Companies are trying to rely less on the human factor for documentation to reduce errors. That's where they're asking more from automation. Meeting CFR21 requirements means that recordkeeping can't be altered. With SCADA and overall data acquisition systems creating considerable documentation, and with different control systems sometimes on each piece of equipment, the interface to that data becomes more challenging, and companies are beginning to dictate to us what control packages they want to consistently collect the necessary data.
Q: In some industries, competitive firms will help one another when it comes to packaging machinery. As you see it, is this the case in the pharmaceutical arena?
A: If you're talking about the drugs and formulas, no. But on the equipment side, we find it's more of a plant-to-plant issue rather than company to company. If one firm's plant is producing insulin, and another company's plant makes insulin, they won't talk, but if they make different products there's some openness. A pharmaceutical customer can talk with another pharmaceutical company that's already using our equipment. It's a good selling tool for us, and it helps them to evaluate the equipment and controls.
--By Jim Butschli, Editor
