Who’s Who in the Company: Departmental Roles, Organization, and Communication
Many biotech companies are very small at start-up, and employees may “wear many hats” (i.e. work as members of multiple departments).
Research and Development
Responsible for discovering/developing a product with commercial value
- Develop processes to make the product
- Determine which raw materials and equipment are required
- Develop a plan for production
- Characterize the properties of the product
- Composition
- Effect, strength, potency, purity, safety
- Product applications
- Develop methods to test the product
Manufacturing
Responsible for making the product
- Preparation of supporting materials
- Operation of equipment and instrumentation
- Monitoring processes
- Implementing corrective actions
- Routine calibration and maintenance of equipment
Quality Control (QC)
Responsible for testing the product to ensure its identity, safety, purity, and stability
- Also responsible for testing raw materials used to make the product
- Performs environmental monitoring within facility
Quality Assurance (QA)/Regulatory Affairs
Responsible for ensuring compliance with CGMP
- Review and approve all documentation
- Store, prepare, and issue documents
- Oversee audit methods, results, systems, and processes
- Training oversight
- Vendor qualifications and inspection
- Validation plans
QA has the ultimate authority to release or reject both raw materials and product lots.