GMP and the RP were on the agenda at the Cosmetics Business Regulatory Summit
There is much dialogue surrounding Good Manufacturing Practice, or GMP. But what does it mean to implement GMP and what are the requirements? Dr Matteo Zanotti Russo from the University of Siena and University of Milano-Bicocca shed some light on this topic with a practical approach to GMP. There is a correlation between GMP guidelines under ISO 22716:2007 and 1223/2009/EC, and successful adherence to GMP is based on the skills of the RP and their team.
However, the Regulation asks the RP to guarantee the compliance of cosmetics and, as Russo emphasised, this is not just the unit that the safety assessor has certified as safe; “the regulation asks the RP to guarantee the safety and compliance of each bottle of product that goes onto the market. How can the responsible person guarantee that?” he asked. The answer is, of course, via GMP. “GMP is the tool to do this – it’s an obligation under 1223/2009/EC – but it is also a tool. Thanks to GMP the product put on the market is representative of the product that that the safety assessor has deemed safe. It’s a declaration of compliance.”
He outlined areas of overlap between the two and gaps as well. For example, the ISO guideline is intended only to establish a minimum standard of the controls that must be led by the RP, therefore the RP should adopt appropriate tools depending on criteria not included in the ISO guidelines but inferred in the Cosmetics Regulation, such as complexity and distance from the production unit.
In order to do this, said Russo, the RP must assemble a team expert in: raw materials and packaging; production processes; in-process and post-process analysis; ISO systems; toxicology; and regulatory criteria.
The two-day Cosmetics Business Regulatory Summit (CBRS) took place at the Radisson Blu Royal Hotel in Brussels from 19-20 May 2015. Legislative issues faced by the global beauty and personal care industry were front and centre.