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Saudi's SFDA: Good Manufacturing Practice for Blood Establishments

Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To maintain high standards of quality and safety, regulatory authorities like the Saudi FDA (Saudi Food and Drug Authority) have released updated guidelines for Good Manufacturing Practice (GMP) specifically tailored to blood establishments.


What is GMP for Blood Establishments?

GMP for blood establishments is a set of standards and practices designed to ensure that blood and blood components are consistently produced and controlled to meet quality standards suitable for their intended use. These guidelines cover various aspects of blood collection, processing, storage, and distribution to ensure the safety, purity, and potency of blood products.


In each blood establishment, a Quality System must be developed and maintained based on GMP principles. In the stages preceding the importation of blood and blood components from outside Saudi Arabia intended for use or distribution in Saudi Arabia, blood establishments must have a Quality Management System comparable to the Saudi Arabian Quality Management System.


Quality Management encompasses all factors affecting the quality of blood and blood components, ensuring they meet the required standards for use. Good Practice is the part of Quality Management that ensures that blood and blood components are produced and controlled consistently to the quality standards appropriate to their intended use.


Benefits of Compliance

Adhering to Saudi FDA's GMP guidance offers several benefits:

  • Ensures the safety and quality of blood products

  • Reduces the risk of transfusion-transmitted infections

  • Enhances public confidence in blood donation and transfusion services

  • Facilitates international harmonization and acceptance of blood products


The guidance discusses topics such as premises, equipments, preparation, and process validation, etc. By following these guidelines, blood establishments can contribute to the provision of safe and effective blood transfusion services.

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