7.1 - Outsourced Wholesale Distribution reference cultures or stage in the manufacturing

or stage in the manufacturing process where this is necessary to ensure its quality and that it is packaged and labelled as specified in the manufacturing record MMR

or any contact surface

and to propose necessary corrective measures

Products that are reprocessed must meet their product specification and be reviewed by Quality

dietary supplements and labels in a manner that does not lead to their mix-up

7.1 - Outsourced Wholesale Distribution reference cultures or stage in the manufacturingFor wholesale distribution of drug products in Europe, irrespective of global location, each facility carrying out these activities must hold wholesale distribution authorisation, covered by a marketing authorisation. The principles of good distribution practice must be followed