تعد المناطق العقيمة من الاشتراطات الرئيسية للتصنيع الطبي في جميع المواصفات العالمية (Annex 1 of the EU and PIC/S GMPs ).
Design Qualification (DQ): documentary evidence that a premises, equipment or process has been designed in accordance with GMP requirements
Installation Qualification (IQ): documentary evidence that a premises, equipment or process has been built and installed in accordance with GMP requirements
Operational Qualification (OQ): documentary evidence that a premises, equipment or process operate in accordance with GMP requirements
Performance Qualification (PQ): documentary evidence that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes