Self Inspection

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Hello,
In a new plant (project stage), Is any requirement of self inspection.
If suggested what will be the frequency.

2

Are you under any regulatory agency (e.g., FDA?) or operating in accordance with any standards (e.g., ISO)? If so, then yes.

I think in general, frequency is yours to decide (again, this can be influenced by regulations or standards). Since you’re new, more frequent is probably better although you need to keep in mind that your company’s product is not internal audits. You’ll also probably want to audit specific areas / processes more frequently than others. This can be guided by a risk analysis.

3

  1. You state you are in a new plant…are you doing activities that are regulated? IF no, then as far as GMP is concerned…we don’t need a self inspection, but it’s STILL a good idea to do one… If you are performing activities that need to be licensed and regulated, then you will need a self inspection.

  2. Frequency-I’ve seen Yearly, 2x year or monthly. LIke the previous responder said, if it’s new…I would stick with more frequency for now.

4

Is any guideline for self inspection which can help me.

5

Maybe I’m confused. Are you inspecting product or auditing your processes?

If you’re auditing, given your original question, I am going to guess that your’re not a certified quality auditor. I would suggest that to get you started, you contract the inspections out to someone who is. In parallel, you could take auditing courses through organizations such as ASQ (I’m not recommending them, I just know they offer CQA training / certification). You could eventually transition from contracted services to in-house.

If you’re inspecting product, this too is a specialized quality field and you probably want to get some expertise - maybe in the form of contract labor. It’s a bit too broad of a field to suggest any specific training or guidelines.

For ISO, employees performing specific functions (such as auditing) are expected to be trained or experienced in doing that job. Were you to just try to work off a checklist for either of the above activities without having sufficient training or experience, you would likely get a non-conformance.

6

I am asking about the self inspection of process/ system as per FDA guideline.