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01-Sep-2019 08:29

The business analysts are looking for gaps in the process.

In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".In the ISO 9015 standard Clause 8.5.1 on control of production and service provision, there is a requirement for you to have controlled conditions for “the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.”This means that a process needs to be validated if you will not be able to check if the product or service is compliant with input requirements.An example might be a soldering process or welding process where you cannot check the strength of every weld during your regular production without damaging or destroying the parts.This article gives an overview of typical applications.Has a customer ever asked you to validate a manufacturing process or procedure, or have you asked for validation from a supplier?

In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".

In the ISO 9015 standard Clause 8.5.1 on control of production and service provision, there is a requirement for you to have controlled conditions for “the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.”This means that a process needs to be validated if you will not be able to check if the product or service is compliant with input requirements.

An example might be a soldering process or welding process where you cannot check the strength of every weld during your regular production without damaging or destroying the parts.

This article gives an overview of typical applications.

Has a customer ever asked you to validate a manufacturing process or procedure, or have you asked for validation from a supplier?

IQFor example, in the medical community, the primary regulatory body is the FDA.