Ensure the proper selection of suitable plasmapheresis donors according to the effective policies
and procedures as well as the as the clinical experience.
Observe and confirm compliance of the Center's medical procedures as they affect the safety of
the donors and the collected plasma.
Responsible for the certification, training and performance of the center medical staff as it
pertains to the donor assessment and to compliance with the company's policies and procedures.
Provide additional necessary training, re-certification and corrective actions for the center's
medical staff, in collaboration with the training department.
Perform the required physical examination for donors.
Review donor's related documents carefully.
Carefully explain the Informed Consent and witness the donor's signature on the form.
In a private and confidential setting, discuss the high-risk behavior educational material and
definitions of high-risk behavior categories in order to provide the donor with the ability to self exclude
from donating.
Participate in the notification and counselling of donors found to be positive for various
infectious disease markers such as HBV, HIV, HCV, syphilis, and other required tests.
Management of Donor Adverse Event Reactions and the appropriate level of care.
Timely review of accumulated data to confirm established donor suitability, donor safety and
product safety.
Review the accumulated laboratory data of SPE, syphilis and Total Protein results in a timely
basis, as well as the collection records, to determine whether the donor should be deferred for
further donation.
Approve a donor whose SPE results were abnormal for plasmapheresis when normal results are
obtained
Recommend changes and improvements to Standard Operating Procedures.
Provide education sessions to the center medical staff according to the company's Standard
Operating Procedures (SOP).
Learn, understand and be independent working with the PDS (Plasma Donor System).
Follows all GMP and good documentation practice guidelines.
Review the QA reports for timely and appropriate actions on moderate complexity procedures
for test problems.
Grifols Egypt for plasma derivatives is a joint-venture (JV) company between the Egyptian Government, through the National Service Projects Organization (NSPO) and Grifols, the global leader in plasma medicines with more than 110 years of contribution to improving the health and well-being of people.
This joint venture is the first of its kind in the plasma industry and the first-ever Egyptian source member of the Plasma Protein Therapeutics Association (PPTA). GEPD is a groundbreaking global public-private alliance that will benefit the entire region.
GEPD is committed to developing the plasma medicines market and achieving self-sufficiency in these critical therapies, which is crucial for the Egyptian healthcare system.
We are combining the expertise of both shareholders to build and operate 20 plasma donation centers throughout Egypt, along with manufacturing facilities including fractionation, purification, and fill-and-finish plants with a processing capacity of up to 1 million liters of plasma annually that can double in the future.
The new manufacturing facility will include a plasma warehouse and a testing laboratory. It will occupy 105,000 square meters strategically located in the administrative capital’s medical city, adjoining various healthcare institutions.
