Characterization and Comparison of quality management systems for cosmetic products in the world

  • German Leonardo Madrigal Redondo Instituto de investigaciones Farmacéuticas
  • Marianela Chavarría Rojas 1Instituto de investigaciones Farmacéuticas, (INIFAR), Pharmacy Faculty, University of Costa Rica, San José, Costa Rica
  • María Fernanda Rojas Salas 1Instituto de investigaciones Farmacéuticas, (INIFAR), Pharmacy Faculty, University of Costa Rica, San José, Costa Rica
  • Daniela González Corrales
  • Esteban Pérez Navarro 1Instituto de investigaciones Farmacéuticas, (INIFAR), Pharmacy Faculty, University of Costa Rica, San José, Costa Rica
  • Mariangel Robles Barquero


The quality management systems are tools that can be implemented in different types of industry with the purpose of achieving improved quality standards on the products or services they develop, mainly looking to satisfy the customer and position themselves in the market with an advantage over the products offered.

Within the pharmaceutical industry there are numerous regulations and laws that regulate and supervise the production of these products worldwide, ensuring that the industries dedicated to this area have certain regulations and meet minimum quality objectives, because they are products that have a high impact on human life and their improper use can mean major problems for it. This is why, over the years, organizations have been formed.

It corresponds to a bibliographic review of international regulations on the manufacture of cosmetic products. Multiple sources are reviewed, from the original standards that contain the minimum requirements for a company that manufactures this type of product, to reviews by auditing and consulting organizations, as well as research on the same subject.

It is important to note that basically all regulations, rules and standards specify the same requirements to meet the needs of the customer, and at the same time, meet the safety and quality of a product that will circulate both in domestic and international markets. In this sense, it is clear that the most widely used standard worldwide is ISO 22716:2007, which is widely disseminated across all continents, and is used as the basis for many of the national regulations implemented in countries. The changes made by local regulations are minimal to the content of the standard, adding some clauses to it, but leaving its basic structure intact.

Keywords: Cosmetics, Good Manufacture Practices, Pharmaceuticals, Quality Management Systems


Download data is not yet available.


[1] ISO Tools. (n.d.). Sistemas de Gestión de Calidad. Retrieved July 15, 2020, from
[2] López Porras, K. (2013). Oportunidades para cosméticos y productos de cuidado personal en la Unión Europea. In Promotora del Comercio Exterior de Costa Rica, PROCOMER.
[3] Minero, F. J. G., & Díaz, L. B. (2017). Historia y actualidad de productos para la piel, cosméticos y fragancias. Especialmente los derivados de las plantas. Ars Pharmaceutica, 58(1), 5–12.
[4] Chaudhri, S. K., & Jain, N. K. (2009). History of cosmetics. Asian Journal of Pharmaceutics, 3(3), 164–167.
[5] Chiari, B., de Almeida, M. J., Correa, M. A., & Borges Isaac, V. L. (2012). Cosmetics Quality Control. INTECH.
[6] Adams, J. (2020). Chapter 13: Compliance with regulations and regulatory bodies. In Pharmacy Management: Essentials fora All Pactice Settings (5th ed., pp. 1–24). McGraw Hill.
[7] March, G. A., Garcia-Loygorri, M. C., Eiros, J. M., Bratos, M. A., & Ortiz de Lejarazu, R. (2018). Microbiological Quality in Cosmetics. In Analysis of Cosmetic Products: Second Edition (Second Edi). Elsevier B.V.
[8] Zhu, J. (2019). Respiratory Exposure to Cosmetic Ingredients. Cosmetic Ingredient Review, 703, 1–4.
[9] Mesko, M. F., Novo, D. L. R., Costa, V. C., Henn, A. S., & Flores, E. M. M. (2020). Toxic and potentially toxic elements determination in cosmetics used for make-up: A critical review. Analytica Chimica Acta, 1098, 1–26.
[10] Cosmetic Ingredient Review. (2014). Unsafe Ingredients.
[11] Garvey, J. (2014). Quality System Design for Cosmetics Product Manufacturing. White Paper, Marzo.
[12] Zambrano, C. A., & Rodríguez, L. P. (2016). Propuesta Documental Para La Ejecución De Pruebas De Calidad Con Miras a Establecer Estabilidad Cosmética. [Universidad de ciencias aplicadas y ambientales]. In UNIVERSIDAD DE CIENCIAS APLICADAS Y AMBIENTALES- UDCA VICERRECTORÍA DE INVESTIGACIONES.
[13] INCONTEC. (2008). Norma Internacional ISO 22716:2007. 4, 42.
[14] Intedya. (n.d.). Buenas Practicas de Fabricación de Productos Cosméticos ISO 22716. 2007–2009.
[15] Palomo, C. (2018). Implantación de la norma ISO 22716 en una empresa de productos cosméticos. Universitat Politécnica de Catalunya.
[16] Ministerio de Salud. (2008). REGLAMENTO TÉCNICO RTCA Productos cosméticos. Buenas prácticas de manufactura para los laboratorios fabricantes de productos cosméticos (Vol. 2008, Issue 231).
[17] Cosmetic Toiletry and Fragrance Association. (2006). International Cosmetic Ingredient Dictionary and Handbook, Volume 4.
[18] U.S. Department of Health and Human Services- Food and drug Administration, C. for F. S. and A. N. (2013). Cosmetic Good Manufacturing Practices. In Guidance for Industry.
[19] Parlamento Europeo y del Consejo. (2006). Reglamento 1907/2006 del Parlamento Europeo y del Consejo sobre la evaluación, autorización y restricción de sustancias químicas REACH. Diario Oficial de La Unión Europea.
[20] The European Parliament and the Council of the European Union. (2009). REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products. Official Journal of the European Communities, L 269(1223), 1–15.
[21] Parlamento Europeo y del Consejo. (2013). Directrices relativas al anexo I del Reglamento ( CE ) n o 1223 / 2009 del Parlamento Europeo y del Consejo sobre los productos cosméticos. 3, 82–105.
[22] Diario Oficial de la Union Europea. (2006). DECISIÓN DE LA COMISIÓN de 9 de febrero de 2006 que modifica la Decisión 96/335/CE, por la que se establece un inventario y una nomenclatura común de ingredientes empleados en los productos cosméticos. 9 de Febrero, 2, 528.
[22] Cosmetics Europe. (2008). Guidelines for the evaluation of the efficacy of cosmetics products. Revision may 2008. May, 1–18.
[23] Meloni, M., & Berardesca, E. (2001). The impact of COLIPA guidelines for assessment of skin compatibility on the development of cosmetic products. American Journal of Clinical Dermatology, 2(2), 65–68.
[24] Cosmetic Toiletry and Fragrance Association and The European Cosmetic Toiletry and Perfumery. (2004). Guidelines on Stability Testing of Cosmetic Products. Cosmetic Toiletry and Fragrance Association and The European Cosmetic Toiletry and Perfumery Association, March, 1–8.
[25] The German Cosmetic Toiletry Perfumery and Detergent Association. (2015). General Guidance for Manufacturers and Distributors of Cosmetic Products in Germany Status : 02 December 2015 Essential contents of the EC Cosmetics Regulation.
[26] The Cosmetic Toiletry & Perfumery Association. (1992). Good Manufacturing Practices CTPA GMP Audit 1992. 44(0), 5–7.
[27] HPRA. (2016). Guide to Good Manufacturing Practice of Cosmetic Products HPRA Guide to Good Manufacturing Practice of Cosmetic Products. April.
[28] Conselleria de Sanidad. (2002). Sistemas de calidad de la industria cosmética en la comunidad valenciana: Aproximación al crecimiento en calidad y seguridad (G. V. C. de Sanitat (Ed.); Primera ed).
[29] Ministry of Health and Welfare. (2000). Standards for Cometics, Japan.
[30] Boer, E. de. (2014). Understanding and Implementing the Requirements of the Iso 22716 Good Manufacturing Practices ( Gmp ) Certification a Discussion About the Challenges , Impacts and Opportunities for the Production ,. International Business Development Manager, Cosmetic Industry. SGS, February.
[31] González Abellán, E. F., & Martínez Pérez, D. (2018). Quality Control of Cosmetic Products: Specific Legislation on Ingredients. In Analysis of Cosmetic Products: Second Edition (Second Edi). Elsevier B.V.
[32] Chung, M. H., Huang, W. S., Chang, Y. C., Chen, Y. H., Lee, M. S., Huang, S. C., Chen, Y. P., Shih, D. Y. C., & Cheng, H. F. (2014). A review of quality surveillance projects on cosmetics in Taiwan. Journal of Food and Drug Analysis, 22(4), 399–406.
[33] Abu Shaqra, Q. M., & Al-Groom, R. M. (2012). Microbiological quality of hair and skin care cosmetics manufactured in Jordan. International Biodeterioration and Biodegradation, 69, 69–72.
[34] Minister of Justice. (2010). Food and Drug Regulations Règlement sur les aliments et drogues. In Drugs.
[35] Cosmetic Regulations, 30 (2019).
[36] NAFDAC. (2020). Nafdac Good Manufacturing Practice Guidelines for Cosmetics Products 2018.
[37] Iwegbue, C. M. A., Bassey, F. I., Tesi, G. O., Onyeloni, S. O., Obi, G., & Martincigh, B. S. (2015). Safety evaluation of metal exposure from commonly used moisturizing and skin-lightening creams in Nigeria. Regulatory Toxicology and Pharmacology, 71(3), 484–490.
[38] González, N. (2010). Elaboración de un programa de control de gestión para una empresa de manufactura de cosméticos, basado en el manual de buenas prácticas de fabricación de productos cosméticos de Caveinca. In Universidad Monteavila (Vol. 1, Issue 1). Universidad Monteavila.
[39] Gallardo Suárez, G., & Carrillo García, M. (2017). Rediseño del sistema de gestión de calidad de la empresa Scalpi Cosmética. Reponame: Repositorio Institucional Sergio Arboleda, 14.
[40] Rodriguez Labrador, S. M. (2018). Propuesta integral del sistema de gestión para las buenas prácticas de manufactura del sector cosmético colombiano. SIGNOS - Investigación En Sistemas de Gestión, 10(1), 57–75.
[41] Kingham, R., & Beirne, L. (2011). Cosmetics Regulation in the United States and the European Union: Different Pathways to the Same Result. Enforcement, Litigation & Compliance Conference, 5.
26 Views | 5 Downloads
How to Cite
Madrigal Redondo, G. L., M. Chavarría Rojas, M. F. Rojas Salas, D. González Corrales, E. Pérez Navarro, and M. Robles Barquero. “Characterization and Comparison of Quality Management Systems for Cosmetic Products in the World”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 47-56, doi:10.22270/ijdra.v9i3.491.