Food Safety Plan and supply chain preventative controls question

We created several Food Safety plans for our beverage processes and will be having a GMP audit in several months.

When developing the plans, I had a hard time determining whether we need to have supply chain preventative controls.

We receive glass bottles, flavors, liquid sugar and other ingredients from suppliers approved through our supplier approval process.

What is the rationalization to determine if we need supply chain preventative controls other than our supplier approval program.

Thanks

Leo

1. What are the significant risks associated with these products, if any?

2. If there is a significant risk, who is in charge of mitigating that risk? If it's your supplier, then that's a supply-chain control.  You'd need some type of documentation from them (their food safety plan or statement about how they control the risk, COA's or test results, etc.)

Try to keep those controls on your risk/likelihood table as well. Not every supplier needs to have independent lot testing of pesticide residues for example. But if you're relying on them to provide something RTE that needs to be cooked/treated, verifying that with some other method would be a worthwhile PC.

_{If you process controls any possible significant hazard from the supplies, not supply chain control needed.}

_{We had an FDA audit and he said to use appendix 1 to the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry. https://www.fda.gov/...a/ucm517402.pdf}

_{It spells out the expected hazard for each product. If it is listed, you need a control. If not listed, no control needed.}

And glass bottles fall into the GRAS category (generally regarded as safe)...........although I'm still a little leary with offshore glass

How you will be sure that you produce safte beverages if you dont control your supply chain. 

How you made verification? Are you interested what you recive? Many flavourings and colorants are limited for usage, from them comes many hazards. How you can make your labels according to allergens? if your supplier change some recipe and dont inform you, how you will identifie this to change and your labels? 

You should make chacking your supply chain for those hazards which you are identified in your hazard analysis on the step for purchasing. For those hazards in your HACCP you should determine which preventive measures you will take to eliminate the risk or reduce it to acceptable level.

You should take into account and where you sell your products. To identify is there some other regulations for your product and to ensure that your product confirm with legislations of each country where you sell.

The galss is primary packaging and is in direct contact with the product. You should be sure that confirm with requirements for it. You should have monitoring program for what, when, with which methods, where, etc. should be tested.

it is not enough only supplier evaluation.

Best regards,

Ivan