To ensure that all necessary testing is carried out and the associated records evaluated;
To approve specifications, sampling instructions, test methods and other Quality Control procedures;
- To approve and monitor any contract analysts;
- To ensure the qualification and maintenance of his department, premises and equipment;
- To ensure that the appropriate validations are done;
To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. Other duties of Quality Control are summarised in Chapter 6.
The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the quality management system.
These may include, subject to any national regulations:
- The authorisation of written procedures and other documents, including amendments;
- The monitoring and control of the manufacturing environment;
- Plant hygiene;
- Process validation;
- The approval and monitoring of suppliers of materials;
- The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
- The designation and monitoring of storage conditions for materials and products;
- The retention of records;
- The monitoring of compliance with the requirements of Good Manufacturing Practice;
- The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
- Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement
- Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.