014 Quality Unit Roles and Responsibilities
014 Quality Unit Roles and Responsibilities
Roles and
Responsibilities
Overview
• Directive Statement and Scope
• Glossary
• Responsibilities
• The Requirements
• What cannot be delegated
Typical responsibilities for QA
Typical responsibilities for QC
Typical responsibilities for Regulatory QA
(RQA)
1. Directive Statement
• There must be in place both Quality Assurance
(QA) and Quality Control (QC) functions in a
defined and approved organizational structure.
Site Management
• is responsible for implementing the Quality System at the site.
4. Responsibilities (2)
Site Management
• must allow Quality Unit independence and the necessary
objectivity required, to fulfil its responsibilities
• The QCU shall have the responsibility for approving or rejecting all
procedures or specifications impacting product quality
• The size and complexity of the site will determine how the functions
will be structured within the Quality Unit
• Ensuring that effective systems are used for maintaining and calibrating
critical equipment and instrumentation
• Management of sub-contractors
• Management and monitoring of distribution centres
5.1 Typical Responsibilities of QA (2)
• Complaint investigation and product recall coordination
• Quarantine system
5.1 Typical Responsibilities of QA (3)
• Training programs (e.g. GMP, GDP)
• Supplier or vendor audits, qualification and approval
• Stability program
• Maintenance and calibration program approval
• Pharmacopoeia reviews
• Environmental monitoring
Any Questions