- Production specifications
- Controls of production
- Calibration of equipment (also discussed in the section on equipment)
- Testing samples of the product to determine if they meet the specifications
Section 211.170 establishes the need to retain a sample for future testing.
Section 606.140 (detailed below), requirements are presented that apply to cGMP for blood and blood components:
- Test systems and equipment must be monitored for reliability, accuracy, and precision.
- Specimens must be accurately related to the patient or donor.
Laboratory control procedures shall include:
12 (a) The establishment of scientifically sound and appropriate specifications, standards, and test procedures to assure that blood and blood components are safe, pure, potent, and effective.
(b) Adequate provisions for monitoring the reliability, accuracy, precision, and performance of laboratory test procedures and instruments.
(c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient where applicable.
