Lab Scale Manufacture to cGMP

Lab Scale Manufacture to cGMP

  • £528.00


This service bridges the gap between lab samples and full scale manufacture.  Material made in a lab for evaluation purposes is not covered by ISO 22716.  It can be used for stability,microbiological evaluation and similar.  It cannot be used for such purposes as consumer evaluation or sampling.  But it is often prohibitive to go to full scale production for this kind of activity.

To overcome this we can make lab scale batches to full cosmetic GMP following ISO 22716 where it is practical to do so.  The batch size we can make will vary depending on the nature of the product.  A cold mix single phase material might be doable up to 25Kg.  A hot mix might only be practical up to 3Kg.  In either case the raw materials will need to be supplied or paid for in addition to the manufacturing charge.

Do note that things can go wrong in labs. The work is carried out by very experienced operators following good operating practices, it isn't possible to carry out the kind of scale up and validation that would be carried out at full scale.