Posts Tagged ‘Small/Large volume parenterals (SVP/LVP)’



Requalification – GMP-requirements for the pharmaceutical industry are valid worldwide

The initial achieved qualification status has to be maintained durably. For this purpose, relevant influencing factors on General Manufacturing Process (GMP) have to be checked periodically. The regulatory requirement of requalification is mandatory worldwide. Prominent superordinate regulations are the GMP guidelines of the US and the EU as well as the guidelines of PIC/S. …more


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