Sterile products must be manufactured in a manner that eliminates or minimizes microbial contamination. Generally, sterile devices are manufactured in clean environments, while sterile drug products are manufactured using aseptic (or free from contamination) process methods where the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined and filled into a container (such as a syringe). Often times, the final dosage form cannot be sterilized at the end of the manufacturing process, since the drug substance would become degraded; sterility must be assured during the manufacturing process by using microbial controls, sterile filtration, and facility design, all of which must follow regulatory guidelines.
This four-course certificate explores the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, as well as validation and compliance specifications. Attention is also focused on the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration, and aseptic processing methods. This certificate is available entirely online.
Required courses:
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Production of Sterile Products (5492) OR Sterilization Processes (5493)
Students must also take two (or three) electives from the following:
- Statistical Quality Control (5451)
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Vaccines: RA and QA Issues (5572)
Students who did not receive the MS in RAQA from Temple University are required to complete five courses. All courses must be completed within a four year period with an overall B average.
Application Information for RAQA Post-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Post-Master's Certificates
- Contact the RAQA office to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Post-Master's Certificates
- A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- You must apply before starting the program on the Graduate Application Portal.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to qara@temple.edu. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
- Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
- Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details.
Questions?
Contact our office directly to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.