Could any one write to me:
How many types of SOPs are there for validation?
How many SOPs applicable to validation?
What are the SOPs strict requirement for validation projects?
Could any one write to me:
Well, I see it’s been a few days since the original post and there have been no replies… I hate to see a thread with no discussion so I’ll venture out into the water.
Maybe the reason there have been no responses is that the questions are a bit confusing. SOPs aren’t validated. You might have SOPs that describe your company’s validation approach and you should probably have a Master Validation Plan (which may or may not be a SOP according to local definitions). You might have SOPs (or Work Instructions) that describe how a process is performed and may be referenced in a validation.
There’s a recent thread on the definitions of validation & qualification. This might be helpful.
Maybe a clarification is needed: what is the particular problem you’re trying to resolve? If you’re just digging for basic information, I would recommend using the search tools to find threads on validation (and qualification) to get you started.
iam absolutely agreed with you. SOP can be formalized based on the Validation prtocols generated during Qualification & Validation of Equipements & process respectively.Further if we consider the query of Mr Anil, VMP is the only master document which can be considred as a SOP in general for Validation.
SOPs are be classified into 8 categories, generally. They are,
- Documentation and controls
- Facilities (Equipment and Utilities)
- Materials and Product controls
- Prrocess assurance
- Analytical controls
- Incident Management
I hope answered.
Thank you very much for your replies.
Well, I am looking for information about the types of SOPs should be there in Validation department.
Ah, now I understand… sort of.
As with all SOPs, it depends on what your validation department does. I can only speak from experience in 13485 / US FDA, but if you do product V&V, you probably have a SOP that outlines your procedures for Design Verification & Validation. If you do manufacturing equipment / process validation, then you would have procedures for those activities.
Either way, you should probably have a calibration SOP since both types are likely to use measurement equipment.
IMO, SOPs shouldn’t be something you can just pass from company to company. They need to reflect how YOUR business does work. Of course, you have to meet the regulations so first you need to understand why you think you need SOPs, then develop them to at least minimally meet the regulations while reflecting your business practices.
ISO 13485 certification is meant for sterile medical devices.We too are engaged in sterile medical devices manufacturing and having this certificate.
Could you share non compliance observed by 13485 auditor?
First off, 13485 is for all medical devices, not just sterile.
What kinds of observations are you interested in? Just as they relate to the validation department? If that’s the case, then here’s a few:
– using equipment that is not calibrated / past calibration date
– using uncontrolled product (e.g., no lot traceability)
– not following the procedures (which could be just about anything)
– not following good documentation practices
The list could go on and on but hopefully you get the idea.
Hello in my company I built the following SOPs:
13-Cualifications of WKT,Servers, etc
In our company, I have SOPs rather like Carlos describes - one SOP for each step of a validation sequence. We used to have a single SOP covering the whole thing, but it was too long and too complicated to work through.
Through the valdiation plan, a validation leader describes how they intend to do the actual work, and which steps will be required - and just as importantly (sometimes even more importantly) which steps will not be done.
So for example, we might speed up an existing machine - in which case we would not do a URS, FS, DS, IQ (or some other bits) as the machine already exists and is installed. But we would do an optimisation study, challenge the operating limits we intend to use in production (ie worst case challenge) and do a PQ over the whole line to run the process in its real operating state.
Each SOP includes a template that can be used, but we don’t insist on that. Provided basic GDP is used (eg every page has the document reference number, the issue number, the title and “page x of y” etc) then any format is OK with us. Each SOP also includes the list of all SOPs - I am very conscious that with lots of individual SOPs, users may have to search around to find any particular one (and our electronic document management system is user hostile in the extreme sadly).
We also have a “top level” document which describes the overall intention of validation and how it will be conducted. In any audit, this is the first thing we would present in answer to any valdiation question, as it sets the scene for the detailed SOPs beneath it.
Just the way we do it.
as I see, you are just in discussion about SOP. My question coming from low level of documentation…from your experiences, what do you think…is it better to have ONLY SOPs or SOP + work instructions???
Let me explaine more…
In my factory, we have SOP about SOP and after that we always generate SOPs…maybe is better to have separated SOP and work instructions???
Once more question…what is the first-top-main document in the factory???
Do you have a ‘‘tree’’…I mean…flow chart-graph of documentation in the sense of level-hierarchy???
Is there possible to see an example???