Performance Qualification (PQ) of Pharmaceutical Equipment : Pharmaguideline

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Performance Qualification (PQ) of Pharmaceutical Equipment

Performance qualification is the assurance of the system or equipment performance that is documentented.
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.

Performance Qualification of System and EquipmentBut 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.

Related: Installation Qualification (IQ) in Pharmaceuticals

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.

Related: Design Qualification (DQ) of Equipment

Performance qualification is a part of equipment validation process and 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.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

5 comments: Post Yours! Read Comment Policy ▼

  1. Dear Sir

    This blog is very useful and really educated. And I will be more thankful if you can can share PQ protocol sample/template for HVAC and incubator...please send it

  2. Three reactors are used for same purpose (Hydrolysis). Can I use single Performance Qualification Protocol for the re-qualification of the three reactors? Please suggest.

    1. You you can use same for all but make separate copy for each with their equipment id.

  3. Dear Sir,

    Your information is very informative and useful for me. Can I ask if you can share some information related to IQ,OQ and PQ for balances using in GMP area, from small scale to large scall. Thanks a lot for your sharing and appreciate for your reply.


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