Sterile Process Manufacturing Post-Master's Certificate

Study the techniques and applicable regulations used in the development and manufacture of sterile products with the Sterile Process Manufacturing Post-Master’s Graduate Certificate from Temple University’s School of Pharmacy. This post-master’s certificate may be completed on either a full- or part-time basis and affords students the opportunity to continue their education in the field of sterile product manufacturing and the elimination of microbial contamination.

Through completion of the certificate, students gain an understanding of

  • routes and types of administration of sterile products;
  • regulations, processes and unique considerations involved with sterile parenteral products;
  • manufacturing and facility requirements for the design and production of sterile products;
  • validation and compliance specifications for sterile products; and
  • methods used for sterilization, including regulatory requirements for thermal, gaseous, radiation, filtration and aseptic processing.

Classes & Curriculum

In this post-master's certificate program, you must complete two required courses, as well as two to three electives. The number of electives you take will be based on whether or not you received your master’s or doctorate degree through Temple’s Regulatory Affairs and Quality Assurance (RAQA) program. Graduates from Temple's RAQA program must complete two electives, totalling four courses and 12-credit hours.

Graduates from any other institution must complete three electives, totalling five courses and 15-credit hours.


Microbiological Concepts in Pharmaceutical Manufacturing

Production of Sterile Products OR Sterilization Processes


Statistical Quality Control

Production of Sterile Products

Sterilization Processes

Development of Sterile Products

Vaccines: RA and QA Issues

Learn more about the Sterile Process Manufacturing Post-Master’s Graduate Certificate courses.

Related Graduate Degrees

Related Graduate Certificates

Delivery Method

The Master of Science in Global Clinical and Pharmacovigilance, Master of Science Non-Thesis in Pharmaceutical Sciences, Master of Science in Regulatory Affairs and Quality Assurance, and most certificates can be completed in-person at Temple’s Fort Washington location or online. The Regulatory Affairs and Quality Assurance graduate program offers more than 60 elective courses online.

Online courses in the RAQA program are offered in real time. You’ll participate in classes each week at a specific time, watching live lectures given by your instructor through interactive platforms. This format enables you to interact with other professionals across the country and world.

Career Opportunities 

Alumni and current students of the Regulatory Affairs and Quality Assurance graduate program can join the job postings listserv to gain access to current career opportunities.

Career Night
Regulatory Affairs and Quality Assurance hosts an annual career night for students to meet with representatives from at least a dozen actively hiring companies. The evening features presentations on topics for breaking into the industry and gaining employment, such as interviewing tips and resume writing.

Students are also encouraged to speak with Regulatory Affairs and Quality Assurance faculty about their professional goals and ambitions.

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this Graduate Certificate offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more. These tuition costs apply to the 2019–2020 academic year.

Pennsylvania resident: $1,072.00 per credit
Out-of-state: $1,358.00 per credit

Learn more about our tuition and fees.


Additional Program Information