1. RESPONSIBILITIES
1.1. Shared Responsibilities (Heads of Production and Quality Unit may share/jointly exercise some responsibilities relating to quality)
1.1.1. authorization of written procedures (SOPs) and other documents
1.1.2. monitoring and control of manufacturing environment
1.1.3. hygiene
1.1.4. process validation and calibration
1.1.5. training, including application and principles of QA
1.1.6. approval and monitoring of suppliers and contract acceptors
1.1.7. Designation and monitoring of storage conditions for materials and products
1.2. Head of Production
1.2.1. Product production and storage according to appropriate documentation
1.2.2. Approval and implementation of production instructions, in-process QC and ensure strict implementation
1.2.3. Ensures that production records are evaluated and signed by designated person
1.2.4. Checks maintenance of production department, premises and equipment
1.2.5. Ensures process validation and calibration performed, recorded, and reports are made available
1.2.6. Ensures initial and continuous training of production personnel
1.3. Head of Quality Unit
1.3.1. Approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation with their specifications
1.3.2. Evaluate batch records
1.3.3. Ensure that all necessary testing is carried out
1.3.4. Approve sampling instructions, specifications, test methods and other QC procedures
1.3.5. Approve and monitor analyses carried out under contract
1.3.6. Maintenance of the department, premises and equipment
1.3.7. Validations (including analytical procedures) and calibrations of control equipment are carried out
1.3.8. Initial and continuing training of quality unit personnel
1.4. Authorized person
1.4.1. Compliance with technical and regulatory requirements
1.4.2. Approval of the release of finished product for sale
1.4.3. Function may be delegated to another person (e.g. QA)