Product quality and consumer protection requirements similar to those for manufacturing pharmaceutical products also apply in the cosmetics industry. Consumers place great emphasis on safety and sensory quality. Everyone uses products like shampoo, creams, shower gel, lipstick and deodorant day in and day out – relying on consistent, dependable quality.  That is why clear rules for good manufacturing practices apply for cosmetics products in the form of cosmetics GMP defined for instance by DIN EN ISO 22716. 

So these are recommendations based purely on the state of knowledge and technology? Far from it! Some cosmetic products are subject to strict and legally binding GMP requirements. The US FDA for instance prescribes that “all cosmetic products and their active ingredients claiming a healing or protective effect” have to be manufactured according to exactly the same GMP rules as pharmaceutical products. 21 CFR 210/211 – the American cGMPs – or ICH Q7 are clearly prescribed standards that must be followed. But the threshold where this begins to apply is flowing and not always clearly discernible. The question is what requirements have to be met and where. This is where profound consultancy ensures compliance.

gempex with numerous projects in the cosmetics sector and a multitude of supported inspections has the required expertise and is able to answer all compliance questions comprehensively and with reliability. Projects often begin with a workshop or training to first clearly define the applicable requirements. A GAP analysis offers certainty when it comes to identifying what is missing and what remains to be done. Suitable, pragmatic GMP concepts or perhaps just a simple GMP upgrade are important steps on the way to manufacturing cosmetic products in compliance with regulations, yet also economically and therefore competitively.

gempex is a proven expert in all GMP matters for the cosmetics industry and its suppliers. Since we highly value the trust and confidentiality of our customers, we purposefully refrain from disclosing our customers in general. 

Select Service Examples*

  • Producing Bulk Goods for the Cosmetics Industry 
    Support for the implementation of EFfCI, global and local, Standardisation of technologies and quality systems related to EFfCI
  • Raw Material Producers for the Cosmetics Industry
    Qualification of a track & trace system for product serialisation
  • Production of Special Chemicals in the GMP-regulated Cosmetics Sector
    Preparing for and conducting FDA audits, customer audits, preparing for and accompanying official audits
  • Manufacturing Cosmetic Products with a Pharmaceutical Orientatio
    Consultancy and support for obtaining production approval

* We will gladly provide you with specific references on request.