Quality Assurance: Activities and Responsibilities

• Release of qualification and validation protocols
• Release of documents: e.g. specifications; Master Batch Records, SOPs
• Batch review and release, archiving
• Release of batch records
• Change control, deviation control, investigations
• Approval of validation protocols 
• Training
• Internal audits, compliance
• Supplier qualification and supplier audits
• Claims, recalls, etc.

Quality Control: Activities and Responsibilities

• Development and approval of specifications
• Sampling, analytical check and release of raw materials, intermediates and cleaning samples
• Sampling, analytical check and approval of APIs and finished products
• Release of APIs and final products
• Qualification and maintenance of equipment
• Method transfer and validation
• Approval of documents: e.g. analytical procedures, SOPs
• Stability tests
• Stress test