Bars

Major GMP Guidlines

• Part III - GMP related documents

• Site Master File

• ICH guideline Q9 (R1) on quality risk management

• Q10 Pharmaceutical Quality System

• MRA Batch Certificate

• Template for the 'written confirmation' for active substances exported to the Eu ...

• Guideline on setting health based exposure limits for use in risk identification ...

• Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining t ...

• Template for IMP batch release (applicable as from the date of entry into applic ...

• Guideline on the responsibilities of the sponsor with regard to handling and shi ...

• Reflection paper on Good Manufacturing Practice and Marketing Authorisation Hol ...