(1) Review and approve SOPs and training plans.
(2) Review and approve validation and validation plans.
(3) Review and approve document control and record-keeping systems.
(4) Lot release, i.e., the review of all operations or manufacturing records and
the decision whether to distribute, quarantine, or discard blood and blood components.
(5) Audit of operational or manufacturing functions.
(6) Review and approve reports of adverse reactions, errors and accidents,
deviations, and customer complaints.
(7) Participate in a material review board, a group that reviews deviations in
supplies received or in the blood manufacturing process and determine the suitability for
use based on a documented decision-making process.
(8) Review and approve corrective action plans.
(9) Develop criteria for evaluating systems and identifying negative trends so
that changes can be made before a situation worsens and products are affected.
(10) Perform surveillance of problems.
(11) Prepare yearly reports of findings, corrective and preventive actions.
(12) Review and approve vendors.
(13) Review and approve product specifications.
1-3. FACILITIES AND PERSONNEL
a. The cGMP regulations require adequate space and ventilation; sanitation and
trash disposal; equipment for controlling air quality and pressure, humidity, and
temperature; water systems; and toilet and handwashing facilities. The QA unit is
responsible for ensuring that the facility meets requirements.
b. The cGMP regulations also requires that there be adequate personnel with the
appropriate education, training, and experience to ensure competent performance of
assigned duties. CLIA >88 establishes personnel qualifications and similar training
requirements for laboratory staff. Personnel, including volunteers, must be trained and
certified as competent to perform assigned duties before being allowed to work
independently and must have regularly scheduled competency evaluations to ensure