2 replies to this topic

[marie246]

Hello,

 

Our company is a co-packer company.  I am establishing SOP's for dietary supplements 21CFE111. 

 

We do not packed exposed product, we place finished goods packaged product into a unit carton, apply the lot code and exp. date that it states on the finished good bulk material.  All of the product is customer supplied including all packaging materials.  We do not allow or store opened bulk product in our warehouse, so we do not open up the material and verify the actual product.  Would requesting a CofC for each lot receipt be sufficient as inbound inspection?  We look at the shipment upon arrival and verify for visual signs of damage or contamination but that is all.

 

We also do not retain samples?  Do we need to do so?  I am in the process of writing SOP's for dietary supplements and I am on the QC unit section.  ANY feedback would be appreciated.

 

Thank you in advance.

 

Warm Regards

 

Marie246

[Dr.Khan]

Hi Marie

 

There is no need to check every material you get for repacking. it is important though that you receive a certificate of analysis for each batch of each product you pack and ensure that the certificate of analysis comply with the product specification.

 

You need to keep record of inspection of shipment on arrival as well as production line cleaning record to demonstrate that you have taken all reasonable precautions to ensure that product does not get contaminated during repacking process.

 

Kind regards

Dr Humaid Khan

MD Halal International Services 

Sydney Australia

We work Globally

[Charles.C]

Hi marie,

 

I guess this post is sort of related to -

 

http://www.ifsqn.com...pplier-program/

 

The answer(s) to yr query may relate to the specific reason  for yr activity, eg Regulatory requirements, intending certification to some FS standard, best practice in yr Industry, establishing a QA Program for customers.

 

The textbook answer from a purely safety POV is it relates to risk assessment, eg sensitivity of product, historical/perceived supplier reliability, customer requirements. Many companies test / keep samples automatically for future "protection".