7.1 - Outsourced Wholesale Distribution reference cultures and to propose necessary corrective

and to propose necessary corrective measures

the appropriateness of current specifications for both starting materials and finished product

You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required

The level of effort

7.1 - Outsourced Wholesale Distribution reference cultures and to propose necessary correctiveFor 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