cGMP 4: Equipment, Process and Product

DEFINITION

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To make valid…

To substantiate…

To confirm….

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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.

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…

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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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?

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.

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.

EQUIPMENT VALIDATIONS

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DONOR PROCESSING• Equipment requiring validation:

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Donor Floor

• Equipment requiring validation

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Plasma Processing• Equipment requiring validation

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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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RESOURCES: 21 CFR

211.68 211.84

211.165

820.75

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THANK YOU!