Cosmetics

The process of registration of a new cosmetic ingredient is not simple. The FDA requires the obtention of the INCI number but the evaluation of a dossier containing physicochemical properties, preclinical and clinical data is recomended. In Europe the aplicable REACH and CLP regulations have to be fulfilled as well as the inclusion in the Inventory of Cosmetic Ingredients. A complete dossier it is also mandatory but animal experimentation is forbidden.

For Cosmetic formulations submitted in Europe is applicable the Directive 1223/2009. According to it expiry date, tolerability, microbiological quality and purity has to be demonstrated and a toxicological evaluation has to be performed. The FDA requires a dossier as a pharmaceutical product for the sunscreen products and in some cases is necessary to test the lack of absorption of some ingredients.

Summarizing in the last years the Authorities have increased the control of Cosmetic Products and more strict requirements have to be fulfilled.

 

CMC

Chemistry, Manufacturing & Control analytical services are executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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We have wide experience in performing analytical tests of raw materials, APIs, intermediate products, finished products, packaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods should be used, We perform the method development and validation from scratch or the method transfer from the manufacturer. However, if compendial methods should be employed, a suitability test or a partial validation can be acceptable.

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) and FDA guidelines and using QbD strategies to improve the results. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

We provide full service of ICH and on-going stability programs for third parties. The services, at client's choice, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always performed according to procedures agreed with the client.

We provide microbiological testing for nutraceutical and cosmetic products. A fully-equipped laboratory is available including a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated in Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics in the shortest times.

We have a deep knowledge of spectrometry techniques such as NIR (Near Infrared) and RAMAN. Thanks to this background we have developed consultancy services to help companies to implement QbD for process development and PAT strategies for quality control and in-process control. The most extended objectives are:

  • Use of NIR & RAMAN for identification of raw materials
  • Use of NIR & RAMAN for in-process control
  • Implementation of Process Ananlytical Technology (PAT) strategy oriented to parametric real time batch release
  • Use of NIR for quantitative analysis of drug products

Cleaning validation is a relevant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for following manufacturing processes. Potential contaminants include residues of the active pharmaceutical ingredients or their related substances, and residues from the products used during the cleaning process such as solvents or detergents. This is particullary important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Chemistry, Manufacturing & Control analytical services are executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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We offer you our experience in studies of Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (o Franz cells) according to Chapter <725> of the Pharmacopeial Forum. Both In Vitro Release Test and In Vitro Permeation Test are offered: