Re-Validation criteria and Requirements for Manufacturing equipment on site

I am new to Medical, having tansferred from automotive. One of my first projects at my new company is to compile a Validation / Re-Validation Master Plan for all of our products and the equipment being used.
The question I have is, Is there way of deciding when a piece of manufacturing equipment on site requires re-validating. My thoughts are along the lines of Scrap, Customer Complaints, Change of Supplier, Change of materials and machine change. Any help from the Forum would help greatly.

Re: Re-Validation criteria

The GHTF has a guidance document on process validation at http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf. It contains a section on reasons for re-validation.

Re: Re-Validation criteria

Does the organization have validation procedures in place that specify the need for requalification? Or, is that part of your quest?

Along with the excellent link provided by MIREGMGR, I would also consider developing the plan on a risk-based approach. The higher risk, the more often requalification should occur.

Re: Re-Validation criteria

Change control is a good mechanism for re validation, as is a change to raw materials, engineering modifications, different methods of work.

What's the reject rate like - if you perform a pareto analysis and look at the type and number of rejects over time you might see an adverse trend (or a change in machine defect type).

Re: Re-Validation criteria

Hi

In my company' SOP for validation, the following are mentioned as reasons for Re-validation:

1. Yearly if under continuous operation during or after the Pre‑Production
phase of the program management cycle.
2. A manufacturing process produces excessive defects.
3. Evaluation or troubleshooting of a pass/fail process.
4. Customer complaints or a quality investigation identify the manufacturing
process as a possible cause for defects.

I hope it helps

AndyU said:

I am new to Medical, having tansferred from automotive. One of my first projects at my new company is to compile a Validation / Re-Validation Master Plan for all of our products and the equipment being used.
The question I have is, Is there way of deciding when a piece of manufacturing equipment on site requires re-validating. My thoughts are along the lines of Scrap, Customer Complaints, Change of Supplier, Change of materials and machine change. Any help from the Forum would help greatly.

Click to expand...

Andy,

Great responses so far but would like to add the explanation of the terms -

The equipment are qualified while the process is validated.

You will need to define the broadly two categories re-qualification/re-validation criteria [RQ/RV]
1. predefined / scheduled re-validaiton:- scheduled is based on evaluation of data at preset intervals determined through results/problems in associated areas.

in our case a yearly evaluation was accepted to be adequate. [ but then, it was supplemented by a activities such as calibrations, preventive maintenance tests and suitability tests] underlying statement is that you need to justify the whatever frequency/criteria you will choose to implement them.

2. change : evaluated based on the impact on the process / equipment / product. [change control process and risk assessment activities]
the examples for re-qualification of equipment could be... like...Modifications done to equipment, or relocation of equipment, or replacement of critical spares, ..;

althought it may not be relevant, just enclosing few ref. on the approach given for re-validation criteria for pharma products available under SUPAC guidelines. [just search for it on fda.gov]

[ and obviously the need for justification/review and documentations goes without saying.]

i guess, all the scenarios of failures/problems presented by you shall trigger CAPA/Change-Control, which in turn will determine the need for revalidation/re-qualification.

hope this helps.
valiveti.

This is how I've approached the issue from our business point of view.

We have built a new manufacturing facility where I prepared process flow maps. There is one (big picture map) which shows the main process areas. Each process (manufaturing) area is then split down into some detail.

This provides a visual assessment of all the processes at the new facility.

The equipment is then identified in an excel spreadsheet and given a priority number (based on its impact on product quality).

The equipment is then validated in a logical sequence, and re validation will / would be approached in a similar fashion.

Try and make a complete list of the plant / process/ equipment that affect product quality. Not every piece of equipment / process has the same impact.

By doing this, you can demonstrate some kind of methodolgy and approach to validation and revalidation.

Hope this helps.

AndyU said:

My thoughts are along the lines of Scrap, Customer Complaints, Change of Supplier, Change of materials and machine change.

Click to expand...

These look like good places to start. You may want to take into consideration changes to your procedures, and relocation of equipment. If you move a piece of equipment within the shop you will need to re-qualify it. Also, if you have a piece of equipment that needs major repairs or parts replacements you may consider a re-qualification to assure the repair was effective and/or the replacement part is functioning as expected since that piece was not present during the initial qualification.