The Quality Assurance Unit implements the quality assurance system for biologicals production.  The unit ensures that: 1) products are designed and developed according to good manufacturing practice (GMP) and good laboratory practice (GLP) standards; 2) production and control are specified in a written form and meet GMP and GLP requirements; 3) managerial responsibilities are specified according to accepted standards; 4) manufacture, supply and use of starting materials are done according to GMP specifications; 5) quality control tests on starting materials, intermediate, bulk products and finished products; 6) validation of standard operating procedures are done on production and quality control of products; 7) batch release is approved by an authorized person; 8) proper storage and distribution of the product is carried out; and 9) a self-inspection and/or quality audit system is in place.