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Practices (cGMPs)
Biotechnology
using living cells and materials
produced by cells to create
pharmaceutical, diagnostic,
agricultural, environmental, and other
products to benefit society.
How Do Biotech Products
Differ from Chemical Drugs?
Produced from living cells
Large, complex molecules
Extremely sensitive to their
environment
Production
Storage
Manufacturing changes
What Does FDA Do?
Approve products
Safety
Effectiveness
Risk/Benefit determination
Monitor drug performance
Monitor investigational studies
Inspect manufacturers
Inform physicians and consumers
Biotechnology Companies
make products
Organizational Structure
CEO Chief Executive Officer
COO Chief Operations Officer
CIO Chief Information Offices
Vice President of Research and Development
Vice President of Medical Affairs
VP Sales and Marketing
Operations
Operations responsibilities
Personnel
qualified employees
employees must have training and experience
to perform assigned duties
disease control, and hygienic practices
assign qualified supervisors to oversee
implementation of cGMPs
Components of a cGMP
Physical plant internal environment
design and construction
ceilings, floors, and walls that are easily cleaned
and maintained
separate areas or systems for specific operations to
avoid mixups
screening to keep out pests
maintenance and sanitation
water meets EPA drinking water requirements
plumbing, bathroom, lighting, ventilation, trash
requirements to prevent contamination
Components of a cGMP