Audit checklist for Cosmetics

[Ajit Basrur]

Hi,

We are plastic injection molders for a prospective cosmetics customer. They said they will come for an audit our molding plant with regards to cosmetics requirements.

I know that cosmetics comes under CFSAN division of the FDA but when I referred the website, it only talks about the actual cosmetics artciles without a mention of the containers.

Any ideas what would be the audit like ? Can anyone share any audit checklist if they have ?

Thanks in advance

[ScottK]

I worked in that very same business for 6 years - 3 in moulding (injection and blown), 3 in filling.

I don't have a checklist but I can give you the following tips as I remember from the moulding days:

1. Materials! Materials! Materials! Make sure that you use materials that have nothing on any banned cosmetics list.
2. Make sure you have processes for lot traceability to the plastic, colors, and additives. Even regrind in some cases.
3. If there's anything with SPF that they'll be using your parts for you may have to have you parts in an FDA drug master file (Type III for containers) because SPF is classified as drug product http://www.fda.gov/cder/guidance/1714fnl.htm
4. Inspection and test. Depending on the customer they may specific requirements for things other than dimensionals like light transmission through the material, color limits, flash limits, etc.

I found that cosmetic companies are far more picky about the appearance of the part then the actual dimensions.

As I think of more I'll add.

[Ajit Basrur]

Originally Posted by ScottK

As I think of more I'll add.

Thanks Scott. Shall wait for more info

[ScottK]

Originally Posted by Qualityalways

Thanks Scott. Shall wait for more info

can you PM me the customer's name, if you don't want to post it for the general board. I've worked directly with many the biggies: L'Oreal, Shiseido, Avon, Estee Lauder, Procter & Gamble, Colgate Palmolive, etc.

[ScottK]

Oh yes!

VERY important - a robust line clearance process is an absolute MUST.