Departmental roles, organizations, and communication in biotech companies

What are some of the different departments in biotech companies

R&D, Manufacturing/production, QC, QA

What is the R&D department responsible for?

discovering/developing a product with commercial value

What is the manufacturing/production department responsible for?

They are responsible for making the product

What is the QC (quality control) department responsible for?

testing the product to ensure identity, safety, purity, stability and preforms environmental monitoring (EM) within facility

What is the QA (quality assurance) department responsible for?

ensures compliance with CGMP, has the ultimate authority to release or reject both raw materials and product lots

What are some ways QA ensure compliance with CGMP?

• Reviewing and approving all documentation

• Storing, prepping, issuing documents

• Overseeing audit methods, results, systems, and processes

• Training oversight

• Vendor qualifications and inspections

• Validation plans

What is the difference between QA and QC

QA is process-based and focuses on the processes and systems that create the product (or service).
QC is product-based and tests the final product before it is released.