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 now available entirely online.
Students must complete two required courses:
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Production of Sterile Products (5492) OR Sterilization Processes (5493)
Students also complete two electives from:
- Statistical Quality Control (5451)
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Vaccines: RA and QA Issues (5572)
All courses may be completed online. This certificate allows students to explore QA and RA issues without committing themselves to the entire Master of Science program. The GRE is not required for the Sterile Process Manufacturing Certificate.
All courses taken for the Sterile Process Manufacturing Certificate will count toward the MS degree, as long as students are eligible for admission to the RA and QA master's degree and apply to the MS program before completing their third course. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.
Application Information for RAQA Pre-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Pre-Master's Certificates
- Call the RAQA office at 267-468-8560 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 Pre-Master's Certificates
- A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- 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).
- 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.
- Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
I have wanted to work with sterile products for the past few years, and the option for a Certificate in Sterile Process Manufacturing is partly why I selected Temple's RAQA graduate program. Coincidentally, a few months after starting this certificate, I landed a job in Regulatory Affairs for a sterile drug product manufacturing site. I have learned so much on the job, but the classes on sterile products I have taken for this certificate have been a big help in understanding sterile drugs and how they are developed and manufactured. It is quite an experience to learn something in class and to be able to directly apply that understanding in the office in the following week. It truly made me appreciate those classes and feel more confident in choosing this certificate.
RAQA Student
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu