When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
For most pharmaceutical equipment, the operational qualification phase is usually a walk in the park. In the absence of any form of load, it is very easy to provide the promised specifications. However, performance qualification is what truly determines how viable a piece of equipment is. Suppose a tablet press passes the operational qualification phase with flying colors. But it fails to deliver the same pressure rating with a few grams of powder in it. Or consider a homogenizer, though performing seamlessly when empty, provides only a fraction of the specified rpm with a few hundred kilos of the load in it.
Without performing the performance qualification phase, a piece of equipment might completely fail to deliver any product. But even worse, unknown to the manufacturer, it might produce an undesired product. If the manufacturer does manage to notice that the final product is flawed, then the organization incurs massive losses because of the raw materials wasted on the discarded batch and also loses valuable time, which is as bad as incurring monetary losses, in today's cutthroat market.
If the manufacturer fails to notice and releases the imperfect batch into the market, it exposes them to customer dissatisfaction and massive lawsuits. Now that the importance of performance qualification has been established, we come to the question of whose responsibility it is to perform it.
The pharmaceutical companies, or the various companies manufacturing the equipment? The obvious answer is the equipment manufacturers, right? Not only do they have an ethical obligation to perform performance qualification, but it is essential for providing the clients with the specifications they demand. But the reality is, performance qualification should be performed by both the equipment manufacturers as well as their clients, the pharmaceutical companies.
There are a number of reasons why pharmaceutical plants should perform it. First of all, at the end of the day, if the companies intend to deliver quality products, then it becomes an ethical obligation for them to put their equipment through the performance qualification phase first. Other than that, complex equipment often has indiscernible fragile parts, which may take minor damage while in transit from their manufacturer's location to the pharmaceutical plant. The consequences of such minor damage tend to not show up in the operational qualification phase, but they are observed under load during the performance qualification phase. Also, instead of risking customer dissatisfaction, mediocre products, wasted raw materials and wasted time, it is better to run the performance qualification phase on all the equipment in the plant. So, to summarize, never be satisfied with just the results of the operational phase. Question your equipment further.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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