Design Control - Can Validation be based on a limited/first Production Run



In terms of a registration audit:

Assume proven designs with only basic modifications to add features. Also assume adequate procedures are in place for change management of production controls/ERP/outputs/etc. Is it possible to exclude design and development from the QMS. I suppose there might be 2 levels based on criticality, where the formal design controls kick in.

Is validation a specific requirement that must be completed prior to release of products to the customer. I know this is required under medical device and other regulated products, but not specifically expressed in ISO9001.

Can validation be not required under certain circumstances. For example you designing and building one only. Or level of risk is low based on application or proven elements. If you design and build 1 piece of furniture are you going to validate the reliability of the hinges or UV performance of the varnish used. I don't think so.

Can validation be based on a limited/first production run to the customer and then monitored for negative results in the field.

On the most basic level what is required for records (retain documented information):

- Starts with planning 8.3.2, so I assume we must pre-determine what records are required

Inputs - 8.3.3 - So I assume an authorization/sign-off for approval of inputs is required, but the actual inputs must also de documented. If information comes in defining only general concepts/ideas/need from the customer (often verbal) it may be difficult to document and control. I'm suppose they have to be transformed into some type of written document or master defining them as our input document.

Controls - 8.3.4 - Once again I assume an authorization/sign-off is required on the review, verification and validation stage, but also objective evidence of activities performed at those stages. For example verification or validation would require documented results of tests, alternate calculations, results of inspection, or other verifications or determinations, etc.


Fully vaccinated are you?

Company makes elevator cars. Orders can be as small as 1 car. In this case there is no economic or reasonable physical way to do verification prior to use. Validation is through actual use after installation.

Opinions and information from others are welcome. The above was just something that came to mind, and I know it doesn't fully answer your question.

Ajit Basrur


I am not sure which industry are you in but FDA does accept "concurrent validation" where the validation batch is released for distribution before execution of the protocol steps This is called concurrent release and FDA expects that concurrent release will be used rarely.

The concurrent release might be appropriate for processes used infrequently for various reasons, such as to manufacture drugs for which there is limited demand (e.g., orphan drugs, minor use and minor species veterinary drugs) or which have short half lives (e.g., radiopharmaceuticals, including positron emission tomography drugs). Concurrent release might also be appropriate for drugs that are medically necessary and are being manufactured in coordination with the Agency to alleviate a short supply.

Refer Process Validation: General Principles and Practices"]Process Validation: General Principles and Practices


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