Every country has its own system and requirements in order to register cosmetics and personal healthcare products. Although the required documents and procedures vary quite a bit most have many similar requirements for documents in order to ensure that the product being registered meet their standards for efficacy, safety and quality.

Good Manufacturing Practices (GMP)

A good manufacturing practices certificate show that the cosmetics and personal healthcare products manufacturing company has passed the inspection of the regulatory body of that country and meets the standards of good manufacturing practices as stated by Europe or the USA.

Certificate of Analysis (COA)

A certificate of Analysis is the document that shows the testing parameters of cosmetics and personal healthcare productsaccording to the regulations in which the product was tested to adhere to. The COA shows each test and their correlating results alongside the results the regulation allows. An overall result of whether the cosmetics and personal healthcare products passe or fails according to the regulations is listed at the bottom.

Free Sales Certificate (FSC)

A Free Sales certificate is similar to a COPP where it enables a manufacturing company to list cosmetics and personal healthcare products products in which they can sell in the local market and internationally. A FSC, however can list multiple products at the same time.

DOSSIER

A Dossier is required by most ministries in charge of the regulation of importation to ensure the process the manufacturer uses to produce a cosmetics and personal healthcare product is an acceptable international standard. The Product Registration Dossier is a document that describes all the technical data related to the production, raw materials, standard, stability and quality of the products.The Dossier describes the origin, testing procedures and quality control of all the active and inactive cosmetics ingredients used in the production including their analysis.

The processing of the raw materials is described in detail including the process controls and the critical steps of intermediates. A Flow Diagram is typically used to show step by step the process the raw materials and excipients undergo in order to obtain the final product. The analysis of the final product is described in detail including the test results according to the regulations used for analysis. Full short and long term stability studies are also included to ensure the products can stand the test of time and the elements.