Study Set Content:
Generic drug products (based upon innovator’s NDA).
Abbreviated New Drug Application
For the manufacture of Biologics:
Biologics License Application
For the manufacture of Biologics: examples
Blood products – Vaccines – Toxins
Specific regulations involved
Animal Drug Applications
Allows veterinarians to prescribe extralabel uses of approved animal drugs and approved human drugs for animals
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
The FDA has authority over manufacture and licensing of all medical devices.
Medical Devices
• International marketplace
ICH
To establish a uniform set of standards for drug registration
ICH
ICH countries
US FDA, EU, Japan, and geographic representatives
Established by the FDA
Current Good Manufacturing Practices
Ensure that minimum standards are met for drug product quality
Current Good Manufacturing Practices
First cGMP regulations were promulgated in 1963 under the
Kefauver-Harris Drug Amendments
contains minimum good manufacturing practice requirements for preparation of finished pharmaceutical products for administration to humans or animals
21 CFR, Part 211
Common terms
p.78
authority and responsibility for all functions affecting product quality
Quality control unit
must be educated, trained and have the experience needed
Employees
should possess the required qualifications
Consultants
• Structure, space, design, and placement of equipment must enable thorough cleaning, inspection, and safe and effective use of the designated operations.
Buildings and Facilities
All work must be logged in, inspected by a supervisor, and
signed off
Equipment • Appropriate
Design – Size
