USP 1217 Hardness or Breaking Force harmonized microbiology There shall be written procedures

There shall be written procedures for production and process control designed to assure that the drug products have the correct identity

Quality Control laboratories should be separated from production areas and should be designed to suit the operations to be carried out in them

qualification

The principles of good distribution practice must be followed

or with simulated in-use

USP 1217 Hardness or Breaking Force harmonized microbiology There shall be written proceduresSOP and report form for the break force hardness testing of tablets, or resistance to crushing of tablets, by Quality Control according to USP <1217> and EP 2. 9. 8