GMP News No. 199
24 May 2002
Manufacturing cosmetics products in accordance with GMP guidelines is a costly business. We felt it would be helpful to look at a 3-year-old project to introduce cosmetics GMP by way of a quality management system.
The change to the definition of the word "cosmetics" that was introduced with the 6th Amendment brought the production of cleansing wipes manufactured by Hakle-Kimberley in Mainz, Germany, within the scope of the EU Cosmetics Directive.
As a result the company decided to structure their GMP procedures around a quality management system based on the guidelines laid down by the IKW. External consultants, Concept of Heidelberg, were engaged to help by bringing an independent view, and with the aim of outsourcing as much of the project as possible.
By way of an initial review based on the IKW self-assessment checklist plus questionnaires filled in by R & D, manufacturing and sub-contracting, purchasing and sales, the company's current operating procedures were analysed to evaluate them against GMP standards.
Employee motivation the A to Z of it.
After six-month period of structuring and implementation the QM handbook took effect in October 1998. At first there was hardly any change in the behaviour of the employees. They were at this time still not aware that they themselves constituted a large part of the QM system. It was only after repeated training sessions that they began to "live" the concept.
Introducing the QM system meant on the one hand additional written procedures, but on the other hand doubling up on jobs such as record keeping disappeared. When the system was first introduced the employees were very slow in handling the new documentation. Real acceptance was ultimately achieved when the documentation had to be used to trace an error. From the point of view of user motivation it became clear that SOPs (standard operating procedures) were much more readily accepted if they were written by those using them, rather than asking them to accept a "foreign" SOP. This was particularly obvious in the production area where the SOPs were written by the production manager. Their full integration took longer there than in other departments.
The transition was simplified by the unified layout of the documents, which meant that every employee could quickly find his way around the relevant paperwork. A proper GMP-conforming documentation system was set up by nominating a central co-ordinator for distribution, collection and archiving. This was the only way to ensure that all of the necessary documents were available in the right place, and in the latest version.
A newly introduced monitoring programme, consisting of regular 6-weekly inspections by an outside body, is the key to a critical review of performance (even of the most obvious things) and to identifying potential weakness. A follow-up process ensures the necessary improvements are made.
The incorporation of the R & D area into the GMP system has also led to significant improvements. A structured approach has made R & D projects more transparent and they are more efficiently carried out along project management lines. The QM system provided the opportunity to redefine the point of product handover, and there are now clearly defined lines of responsibility.
It has become easier to maintain critical raw material specifications, with only properly controlled up-to-date documents being used, which are signed by the suppliers. Both parties are clearly and unequivocally aware of their area of responsibility.
The external audits and the monitoring programme critically evaluate the practical introduction of the QM system and lead to the incorporation of improvements.
Thanks to the structured procedures that the QM system requires, and GMP training for the employees, there have been a lot fewer errors. They are now picked up much sooner, meaning that the cost of errors is reduced.
The staff now "live" the QM system, and as part of the process of continuous improvement they themselves now draw attention to any loopholes in GMP procedures. After the usual teething problems the QM system has been accepted and the personnel now feel part of it, with the positive results described above. Hakle-Kimberley is planning to extend the QM system to all of its European plants.