The heads of the production and the quality unit(s) generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, depending on national regulations:
(a) authorization of written procedures and other documents, including amendments;
(b) monitoring and control of the manufacturing environment;
(c) plant hygiene;
(d) process validation and calibration of analytical apparatus;
(e) training, including the application and principles of QA;
(f) approval and monitoring of suppliers of materials;
(g) approval and monitoring of contract manufacturers;
(h) designation and monitoring of storage conditions for materials and products(i) performance and evaluation of in-process controls;
(j) retention of records;
(k) monitoring of compliance with GMP requirements;
(l) inspection, investigation and taking of samples in order to monitor factors that may affect product quality.
