3. 3
PREVIEW
The “process” of creating therapeutics from
plasma proteins is extremely sophisticated,
complex, and lengthy. It’s estimated that,
from the time a donor completes their
donation to the time a patient receives the
medicine takes about 9 months.
4. cGMP’s are the government’s laws for how biological
companies operate their businesses. They must be
followed at all times. Procedures must be established and
maintained to ensure 100% quality control for the end
product. These processes govern how we perform and
document our:
equipment, process, and product validations…
5. EQUIPMENT VALIDATIONS
Each piece of equipment used during a
plasma donation must go through a strict
validation process. Each validation process
must be accomplished carefully and the
same order each and every time.
Documentation is key.
All documentation shall be checked for
accuracy. This is why our Quality
department is so important.
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6. 6
Documentation should be designed to assure it is
secure from alteration, inadvertent erasures, or
loss. We are never to delete anything in the computer,
use white out, or throw away controlled documentation.
Traceability of the unit and documentation of the
procedures used to process that unit is critical from
beginning to end.
Skipping or short cutting any procedure places the full
process in question as well as your integrity.
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Equipment shall be routinely calibrated, inspected,
or checked according to a written program.
Written records of all calibration shall be
maintained; either manually, electronically, or both.
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The products made by Grifols are medications which
enter a human body. At any time this could be your body
or a member of your family receiving these medications…
Do you perform critical validations that would ensure
a safe product for you and your family?
9. PROCESS VALIDATIONS
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Validations begin from the moment a donor arrives in the center,
verifying name, address and SSN. This continues as the donor
proceeds through the process by testing of each unit, regardless of
the number of times a donor has donated.
Included in this process are the steps taken during staging and
shipping of the plasma to ensure temperatures are in
compliance.
When the plasma leaves the center, the Labs continue the steps of
validating the plasma during the transport, storage and hold of plasma
while it waits the 60 day hold prior to manufacturing.
Once the hold is complete, the plasma is subjected to another round
of validation during the fractionation process.
10. PRODUCT VALIDATIONS
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The product validation is completed by monitoring and
verifying the steps used throughout the collection of plasma.
This means that every unit, touched by every member, of
every center is scrutinized to ensure the highest level of
quality for every drop of medication produced.
All lots and containers may not be used until they have been
examined and released for use by the quality control unit.
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There are NO room for short cuts. You must own
every process within your scope of duty.
Patient’s lives depend on YOU! Every donor, every day.
16. BASIC RULES FOR VALIDATIONS & CALIBRATIONS
Containers shall be cleaned when necessary to avoid contaminants;
and should be opened and closed to prevent contamination. Sterile
equipment and aseptic technique shall be used when necessary.
Sample containers shall be identified so important information can be
determined (ex: lot number, name of material).
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