GMP Blood Bank

GMP Blood Bank

 

Blood components are often used in life threatening situations of severely ill patients. Allied to this is a heightened public awareness and expectation of the quality and safety of these products. Therefore, high standards of quality and safety of blood components have to be assured. These high standards can only be achieved by applying the principles of GMP during the collection, preparation, storage, dispatch, quality control and quality assurance of these products.

 

It is apparent that some countries licence blood establishments and blood components, while others do not. However, the principles of GMP should apply to all blood establishments and the blood components which they prepare. It is intended that guidelines already in place, or intended to be issued, by the Saudi Food & Drug Authority (SFDA), would be used in conjunction with this GMP guide. This GMP for Blood Establishments intends only to provide guidance that is specific for blood establishments (including apheresis establishments) and blood components.

 

 

Benefit of GMP blood Bank Certificate

 

The purpose of this document is to provide guidance for GMP-inspectors to use during inspections of blood establishments. However, the document does also give an insight into the thinking and concerns of inspectorates and so could provide some useful information for blood establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of blood and blood components.

 

Consultancy Services Road Map:

 

  • Gap Analyses
  • Designing, Documentation and Implementation (System Development)
  • Internal Auditing
  • Management Review
  • Certification Process Guidance