I have a question for the community. We have traditionally performed our IQ, OQ, PQ's in sequence and have not start the next process until documents were made effective in the qms software. Here is the dilemma, the lag time for the approval process in the qms software can take up to 3 weeks depending on the queue. During this time our manufacturing team has asked if the next phase can be started while the documents are being routed through the qms software. Our answer has been no since an approver may find problems in the prior step and require changes that could have impact on the next phase where they would have to possibly rerun testing. Is this how your teams have performed their process or have you allowed your manufacturing to move forward with their next phase at risk?
IQ , OQ, PQ are different phases of process validation. Unless requirement of IQ would be fulfil, OQ cannot start. Reviewer played an important role if any activity missed or is went in wrong direction. So, it is important to have approval before proceeding to next step.
Documentation activity depends as per QMS on your site. Check the risk of QMS software activity and take decision based on risk.
@Shivanshu Singh Thanks, our thoughts exactly. Constantly defending the practices against manufacturing! Appreciate your reply
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Your's is a common problem. You have to follow your current process until you officially change, meaning change control, risk assessment, etc. However, no regulation precludes you from streamlining your process. Let's think: What's in the 3 wk lag? Is it sitting on peoples' desks? Does it really take that long to review? How many people are reviewing? Do you need that many? You can qualifications of simpler equipment, IOQ; even IOPQ. Of course you may have to rewrite your validation SOPs. My experience says that moving forward at-risk is too risky.
@Norm Howe
Hi Norm, good points. After reading your response I think our biggest issue are resources because the teams are busy reviewing other documents and these are in queue. With everyone's project having priority (we have different divisions), there's not enough folks to handle the workload. My other question, have you ever had situations where mfg. teams want to run verification and validation activities run in parallel? I have had this question come up a few times in the last couple of months. We are used to the traditional flow of verification coming before validation activities. Otherwise we would run at risk and if something fails they would have to start all over.
Not sure what you mean by verification. In our terminology it's a onetime event that happens many times within validation. Sounds like you're referring to commissioning. If so, then a properly documented commissioning can be used or imported directly into validation protocols and save a bunch of time.
@Elizabeth Matheny reading 21 CFR 820 Preamble Comment 81 in third paragraph you find the statement, “It is important to note that design validation follows successful design verification”. Therefore you cannot do them in parallel. Additionally, why validate something that may not be correct and would have to be done over again, adding more cost and time. As pointed out earlier, the problem is not in design verification and design validation, the problem is in your cumbersome review and approval process, that is where you should focus your improvement efforts. Don't focus on shortcutting the process that would improve your process outputs.
@Elizabeth Matheny Recalling my past experience, I have seen acceptance from the regulators when the teams understand the risk when things are being done in parallel. one method used is to have a paper copy of the IQ signed initially by right product and process SMEs ensuring that there are no risks or unverified mitigation controls in PFMEA or other risk documents and proceed to OQ activities. Then obtain approvals in parallel in QMS. The approach is risk based and boundaries of this has to be pre-defined in the QMS procedure to mitigate quality risk and schedule risk for the business. Before completing the validation and moving the process in production, all deliverables need to be confirmed to be completed.
