IQ, OQ, PQ What do they mean And why are they important in medical device manufacturing

1. IQ, OQ, PQ: What do they mean? And why are they important in medical device manufacturing? IQ, OQ and PQ are most common words for people working in pharmaceutical Industries and Medical device Industries. Users may not be aware of these jargon words, but these processes make the product very safe to use. Though they are very old constant evolution is happening based on new development and experience of product manufacturer, user’s experience, and complaints. Let us take the example of one equipment which requires specification to be fulfilled as input. We make provision for input, but IQ requires that risk-based approach should be selected as to see that input, we are providing is how much stable to meet requirement and any variation caused in input has no detrimental effect on the performance of operation. Most of the time we focus on that equipment only and never look at this important aspect. IQ is Installation qualification, OQ is operational Qualification and PQ is performance qualification. Each process has documentation called protocol where how to do Is described what tools may be required to be used and even calibration of tool itself may be necessary which also protocol decides. Protocol also describes in advance as to what is called success of validation. This is called acceptance criteria. Protocol describes that how the process will be evaluated as successful and there is no ambiguity in it. Success answer is clear, and it is nobody’s judgement and opinion. If all acceptance criteria aremet, then validation is declared as successful.

2. Protocol is approved usually by QA before the process starts. So, examination is real with a note that if this is the answer as described in the protocol then your process is successful and is called validated. Process documentation is also reviewed including tools used and their status with respect to calibration if needed. The purpose of process validation is to establish through documented evidence that the production equipment is correctly installed, if IQ is successful then OQ is next step it operates correctly to work to get desired result and then PQ, is performance qualification which describes that process performs safely. Successful validation also gives an assurance that product under normal condition will perform consistently. Generally during IQ, we confirm that device meets the design specification, and it is correctly installed. OQ confirms that medical device operates as per desired specification. One needs to perform OQ for all small parts equipment. PQ validates process stability over the passage of time. Process validation is not choice but its regulatory requirement. Various regulatory bodies have given guideline documents like, FDA 21 CFR 820, Europe has now new MDR which has separate chapter on validation. (Also, ISO 13485-2016), GHTF Quality Management System-Process Validation. (GHTF- SG3-N99-10-2004 edition 2). To understand and interpret guideline and execute sometime may not be possible. Take the help of consultant. IZIEL has all expertise in in it and can support. Consultant can guide well as how process validation is planned, executed, and documented. Do no ignore validation aspect of medical device.Manufacturer may miss hidden risk and can be harmful for user. IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.