How Often Must Product Specifications Be Reviewed Under FDA/BRCGS?

Hey all,

Does FDA/BRCGS require product spec sheets to be reviewed at least every 4 years? If no changes, do I change versions? 

Hi kconf,

I would consider reviewing more frequently and documenting the reviews, the BRCGS standard requires a review every 3 years as a minimum. If there are no changes then you don’t need to issue a new version.

From BRCGS Global Standard for Food Safety Issue 9 Clause 3.6.4:

‘Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years, taking into account product changes, suppliers, regulations and other risks.

Reviews and changes shall be documented.’

Also from BRCGS guidance:

‘Where no known changes have occurred, the specifications must be reviewed at least every 3 years, or more frequently if required by a specific customer, to ensure they remain completely up to date and accurate. Evidence that a review has been completed needs to be available and this should be achieved through the addition of a signature and date to the specification or through the use of a matrix showing specifications and the latest review date and reviewer.’

Kind regards,

Tony

Three years like tony stated in the standard.   there is no need to change the version if you have a way t to prove the review / date.  I PERSONALY change the version and date on spec sheet each review.    

Thank you Tony for references. Thank you King!