The head of Quality Control Department shall have adequate training and practical experience, which can enable the person to perform the functions effectively. He/She shall be given full authority and responsibility in all quality control duties such as establishment, verification and implementation of all quality control procedures. He/She shall have the sole authority to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which were not manufactured in accordance with approved procedures and under the defined conditions.
The head of Quality Control shall have the following responsibilities:
- to approve or reject starting materials, packaging materials and intermediate, bulk and finished products;
- to evaluate batch records;
- to ensure that all necessary testing is carried out;
- to ensure that the critical processes are appropriately verified;
- to approve sampling instructions, specification, test methods, and other quality control procedures;
- to approve and monitor tests carried out under contract;
- to check the maintenance of the department, premises and equipment;
- to establish expiration date and shelf life specifications on the basis of stability test or available stability data related to storage conditions;
- to approve those suppliers of raw materials and packaging materials who are capable of reliably supplying products meeting the company's established quality standards;
- to evaluate all complaints received or deficiencies noted about any batch, if necessary in conjunction with other departments, and to take appropriate action accordingly;
- to maintain adequate analytical records concerning the examinations of all samples taken;
- to recommend contract-manufacturing operations which shall meet the company's specified quality standards;
- to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
