Scope of Activities
1. Biological products release management, examining the problems and providing appropriate solutions.
2. Monitoring the implementation of GMP regulations in production sites, purchasing raw materials, producing biological products, storage conditions, packaging and transportation.
3. Approval of production documents, quality control tests results and their interpretation
4. Supervision of Change Management Process
5. Obtaining manufacturing license of new biological products, renewal and recertification according to regulations
6. Cooperating with production sites to eliminate waste
7. Monitoring the storage conditions of manufactured products and materials
8. Deciding on products with adverse reactions in cooperation with relevant units
9. Providing activity reports
Veterinary Biological Products Release Management
1. Monitoring the manufacturing process (BPR, VMF, SOPs, MF…) to ensure that the regulated product meets its product specification and standards
2. Confirming production summary protocols
3. Confirmation and approval of all relevant specifications, documentations and quality control tests results in order to issue a Certificate of Analysis.
4. Decide whether to repeat and carry out tests if necessary
5. Obtaining manufacturing license of new biological products, renewal and recertification according to regulations
6. Providing production requirements
7. Monitoring the elimination of non-applicable medical products
8. Duties assigned by supreme authority
Medical Biological Products Release Management
1. Monitoring the manufacturing process (BPR, VMF, SOPs, MF…) to ensure that the regulated product meets its product specification and standards
2. Confirming production summary protocols
3. Confirmation and approval of all relevant specifications, documentations and quality control tests results in order to issue a Certificate of Analysis.
4. Decide whether to repeat and carry out tests if necessary
5. Obtaining manufacturing license of new biological products, renewal and recertification according to regulations
6. Providing production requirements
7. Monitoring the elimination of non-applicable medical products
8. Duties assigned by supreme authority
Raw material Release Group
1. Monitoring purchase, storage, distribution and clearance of raw materials
2. Obtaining raw materials documents purchased by commercial management to ensure quality
3. Conducting quality control tests to confirm specification of raw materials
4. Issuing raw materials certificate of approval to notify commercial management
5. Sticking control labels in raw material store
6. Monitoring raw material stock
7. Monitoring timely removal of non-applicable materials
8. Providing required documentation (material specification, guidelines, forms, etc.)
9. Cooperation and coordination with quality assurance deputy directorship, commercial management and production sites
10. Duties assigned by supreme authority