I just want a few completed validations (IQ, OQ, PQ and reports) to read to give me some ideas on format and cement all the guidence concepts I've read.
ideally, if anyone has links to those with that happened to use injection molding to make something, that's best, but even sealers, etc., would be useful.
Yes, I have some questions, but they are concept- if I have an actual validation then I can ask my question(s) and have something specific to reference (so anyone trying to assist can know what specific issue I'm having trouble with).
Thanks!
I am sorry that I am not able to provide you with a set of completed reports and protocols, but I don't do validation anymore. I can give you some pointers though, maybe that can help a bit. (It's just of the top of my head at 07.30 in the morning).
1. Keep your protocols simple, the more complex they get the harder it is to get a well documented and efficient validation. Some argue that you make only one final report summarizing the results of IQ, OQ and PQ. I cannot recommend that. A protocol generates a report. When you have your IQ, OQ and PQ reports then you make a final report encompassing the results of each. That gives a better overview of the validation (IMO). Remember, bullets and numbers are your friend. A number in a protocol is easy to relate to a number in a report.
2. Think of them as the kind of reports that you made during your studies. You define what you want to test, how you will test it, and what your acceptance criteria are. All protocols should be prepared before any validation activities start.
3. "Nobody" can validate alone. Validation should be performed by a group of persons with knowledge of all the processes involved.
4. According to our NB the IQ should be as comprehensive as possible, and cover all aspects of installation, raw materials, surroundings and operation that you can think of. I like that idea, because it leaves the purpose of the OQ to be a thorough Worst Case study.
5. Since you are inquiring relating to plastics, you will want to determine how much variety you can and will accept in your compound. Depending on the finished product you may have a real challenge at this stage. Compounds are tricky things and they can really mess up production if you do not know exactly what the limits of the variety of the compund is.
6. If the validation is to have
any value and effect then it shall identify the process monitoring that will give you the certainty that you have full control of your injection moulding (or whatever process). This should not be simply a visual item control or weight control. This should be a combination of controls such as cooling water temperature - before and after the moulding machine (often forgotten), pressure, temperature, preconditioning of compounds, maintenance of the cast etc. You will want to know when production starts to drift, not when it has drifted....
Hope this helps a bit. Any specific questions, let us know. We aim to please.