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Product Specification Sheets
As part of our GMP requirements, we are required to maintain “Product Specification Sheets.” Not a difficult item, but I am wondering if there is a standard industry format for these sheets? If so, any sources that I could be directed to?
Thanks.
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6 Replies
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In Europe all cosmetic products must comply with laid down regulations and be approved by a “responsible person”.
The current regulations can be found at Cosmetics Regulation (EC) No. 1223/2009together with amendments:
- Regulation (EU) No. 344/2013
- Regulation (EU) No. 483/2013
- Regulation (EU) No. 658/2013
- Regulation (EU) No. 655/2013 (Common Criteria for Justification of Claims)
(+ Guidelines to Commission Regulation (EU) No 655/2013) - Regulation (EU) No. 1197/2013
- Implementing Decision No. 674/2013 (Guidelines on Annex I)
- Regulation (EU) No. 358/2014
- Regulation (EU) No. 866/2014 + Corrigendum
- Regulation (EU) No. 1003/2014
- Regulation (EU) No. 1004/2014
- Regulation (EU) 2015/1190
- Regulation (EU) 2015/1298
- Regulation (EU) 2016/314
- Regulation (EU) 2016/621
- Regulation (EU) 2016/622
- Regulation (EU) 2016/1120
- Regulation (EU) 2016/1121
- Regulation (EU) 2016/1143
- Regulation (EU) 2016/1198
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Spec sheets for your products or for your incoming raw materials?
(I’m not aware of any US standard for either)
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Thanks @johnb, but someone I do not think this answers my simple question….a standard industry format for Product Specification Sheets?
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@Bobzchemist for our products.
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No, not really any standards. But, something like this is typical:
https://www.lubrizol.com/-/media/Lubrizol/Personal-Care/Documents/Personal-Care-Product-Technical-Data-Sheet/Lanocerin-Lanolin-Product-TDS.pdfNote that the more specifications you list, the greater the opportunity for an inspector or customer to find fault with your product. Confining yourself to pH and/or viscosity is usually wise.
Where I work, we combine the spec sheet, together with the formula batch sheet, into one document, so that there’s no chance of confusion over what specification applies to what formula.
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I thought my reply, above, would indicate that there is no industry standard format - or are you prepared to ignore the whole of the European cosmetic industry?
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