The head(s) of the quality unit(s) generally have the following responsibilities:
(a) to approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation to their specifications;
(b) to evaluate batch records;
(c) to ensure that all necessary testing is carried out;
(d) to approve sampling instructions, specifications, test methods and other QC procedures;
(e) to approve and monitor analyses carried out under contract;
(f) to check the maintenance of the department, premises and equipment;
(g) to ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out;
(h) to ensure that the required initial and continuing training of quality unit personnel is carried out and adapted according to need;
(i) establishment, implementation and maintenance of the quality system;
(j) supervision of the regular internal audits or self-inspections;
(k) participation in external audit (vendor audit);
(l) participation in validation programmes.
