Quality Controls of Cosmetic Products

Quality Controls of Cosmetic Products

Analysis for the cosmetics industry

In Switzerland, cosmetic products are regarded, in accordance with the Lebensmittelgesetz (LMG) (The Foodstuffs Act) Article 5 lit. b, as a consumable or item for personal use, which is the reason why The Foodstuffs Act is applicable to cosmetics. What cosmetic products are is defined in Article 35 of the Ordinance of Foodstuffs and Commodities (Lebensmittel- und Gebrauchsgegenständeverordnung).

In the EU, since the 11th of July 2013, the new European Cosmetics Regulation No. 1223/2009, which was published on the 22nd December 2009 (EU Official Journal L342/59-209) is applicable and supersedes the previous EG Cosmetics Guidelines and the former national cosmetic laws. In the EU, manufacturers of cosmetics are required to manufacture their products in accordance with the GMP guidelines.

As your contract laboratory for analysis in Switzerland, we are accredited according to ISO 17025 as well as being GMP and cGMP (FDA) certified. If we carry out chemical and microbiological approval testing for you, we consider ourselves to be a part of your quality system.

Our offer of service has been oriented so that we can offer you integrated analytical solutions. The comprehensive range of analyses that our laboratory can perform allows us to provide you with all approval testing from the same source. This comprises chemical, spectroscopic, chromatographic, galenic and microbiological testing that will be carried out in specialised laboratory units.

Do you have any questions on the testing of your products?

 

We will be happy to advise you.

Read on here for more information or contact us.


Validation status of approval methods

Cosmetic products manufactured in accordance with GMP require validated analysis methods.
Cosmetic products manufactured in accordance with GMP require validated analysis methods.

If you are to manufacture your cosmetic products under GMP, then approval testing must be performed with validated methods. For new products, it is essential to develop suitable analysis methods for release or for stability testing. For this it is necessary to compile, on the one hand, exact information about the product and its formulation; but chemical and technical analysing expertise is also necessary to develop the most suitable analytical method.

The methods of analysis for a product must be validated at the latest before the product is used in humans. Validation of an analytical method provides evidence that the selected method is both suitable and applicable for the analysis purposes intended. Which procedure parameters are to be determined is dependent on the type of analysis and is described in the ICH guideline Q2(R1) and in the FDA guidelines.

Read more on the subject of validation here.

Method transfer

Do you already have developed and validated analysis methods for product approval and do you want us to carry out the testing for you? In this case, a method transfer is generally necessary according to GMP.

Transfer of the methods from your laboratory to ours is carried out after a mutually agreed method transfer protocol has been defined beforehand. With the tests and arrangements described within the protocol, it will be guaranteed according to GMP that the methods will also be valid when carried out in other laboratories or using other equipment.

To obtain this verification, nowadays, the precision in both laboratories will normally be compared with each other. Often, this is done with 6-level determination to the 100% level. The results from these comparisons must fulfil the previously defined specifications. Upon conclusion, the results will be documented in accordance with GMP guidelines in a method transfer report.

GMP contract

In accordance with chapter 7 of the GMP guidelines, it is necessary to conclude a contract when subcontracting out production or analysis. In this GMP technical agreement, the responsibilities and accountabilities in analysis and production in accordance with GMP will be clearly defined.

To conclude and sign a GMP Technical Agreement, just get in contact with us.

Implementation of quality controls for product approval

We will test your finished product samples for implementation of approval testing in accordance with your specifications and with the transferred analytical procedural instructions.
In doing this we incorporate your monograph or testing guidelines into our SOP system, after the method transfer, and create a test plan in our LIMS. When instructed, we will then carry out the tests correspondingly.


Our services in detail:

Microbiological testing of cosmetic products.
Microbiological testing of cosmetic products.
  • Consultation on quality controls
  • Quality controls and approval testing in accordance with the customer’s requirements
  • Method transfer
  • Method verification
  • Method validation
  • Additional services are according to the directory of services or upon request

contact person

sales pharmaceuticals

Michael Trösch Graduate Chemist HTL

Tel. +41 58 434 42 00 Fax +41 58 434 42 01 service@ufag-laboratorien.ch

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