Generic Drug Certificate (Pre-Master's) (RAQA)

This five-course Generic Drug Certificate focuses on the development processes and domestic and global regulations of the generic drug industry. The certificate focuses on key areas: the business environment, domestic and global regulations for generic products, manufacturing processes and science, and distribution practices. 

Two courses are required:

  • Drug Development (5459)
  • Generic Drug Regulation: ANDAs (5473)

Three courses are electives of the student's choosing:

  • The Global Biopharmaceutical Industry (5458)
  • Drug Dosage Forms (5499) OR Solid Dosage Forms - Small Molecules (8004)  (previously Pharmaceutical Manufacturing II)
  • Active Pharmaceutical Ingredients (APIs) (5513)
  • Good Distribution Practices (5543)
  • Global Pharmaceutical Excipient Regulation (5546)
  • Global CMC Issues and Regulatory Dossiers (5576)
  • Analytical Chemistry in Pharmaceutical Laboratories (5655)
  • Special Topics:  Current Topics Affecting the Generic Drug Industry (5650)

Transfer credits are not accepted towards Temple‚Äôs certificate programs. 

Brochure - Certificate in Generic Drugs

How to Receive the Certificate when you've completed the courses.

Submit the following items to the RAQA Office (hard copy only).

1. Application 

2. Photocopies of your undergraduate and graduate transcripts.

3. A transcript from Temple's Banner system of courses taken in the RAQA program.

4. Notice of Completion

All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.

Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.