Sterile Process Manufacturing Certificate

The Sterile Process Manufacturing Certificate in the School of Pharmacy at Temple University focuses specifically on the regulations and quality processes that are unique to sterile products. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program and is available online. A master’s degree is not required to earn this certificate.

Courses explore the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, as well as validation and compliance requirements. Attention is also focused on the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration and aseptic processing methods.

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in sterile process manufacturing. Students study the techniques and applicable regulations used in the development and manufacture of sterile products. To apply for this 12-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biochemistry, biology, chemistry, physics or a health-related discipline.

Learn more about the Post-master’s Graduate Certificate in Sterile Process Manufacturing.

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards.

The School of Pharmacy  

  • pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum;   

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

Certificates provide credentials from Temple’s well-respected RA and QA graduate program, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum

The Sterile Process Manufacturing Certificate may be earned on its own or on the way to the MS in RA and QA.  

To earn the certificate, the following four courses must be completed within a three-year period with an overall B (3.0) average. 

Students complete two required courses.

  • Microbiological Concepts in Pharmaceutical Manufacturing (5512) 

  • Production of Sterile Products (5492) or Sterilization Processes (5493)  

Two electives from the following courses. 

  • Statistical Quality Control (5451) 

  • Production of Sterile Products (5492)  

  • Sterilization Processes (5493)

  • Development of Sterile Products (5501)

  • Vaccines: RA and QA Issues (5572) 

It is suggested that students take at least one of the required courses before pursuing other courses in the certificate. The remaining courses may be taken in any order, and many courses are available on the weekends.

To receive the certificate, candidates must complete the required courses and application procedures. The certificate is open to students with bachelor’s degrees in the sciences. 

All courses must be completed from the School of Pharmacy’s RA and QA graduate program.

No transfer credits from other institutions are accepted. If a student has taken an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that requirement and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate.

Learn more about the Sterile Process Manufacturing Certificate.

See the curriculum.

Requirements 

  • To be considered for the Sterile Process Manufacturing Certificate, candidates must have a degree from an accredited institution of higher learning. (A degree in science or engineering is suggested but not mandatory.) 

  • All courses must be completed from Temple University’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

  • Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion). 

  • Only one certificate program may be completed before students receive the RA and QA MS. 

  • The certificate must be completed within three years. Students must apply for the certificate no more than one year after completing the course requirements. 

  • Students interested in pursuing the RA and QA MS degree may apply all credits earned in the Certificate in Sterile Process Manufacturing towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school. 

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

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

Tuition rates at Temple University 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.

You can view the full Cost of Attendance breakdown on the Student Financial Services website. You can also view the the tuition rates for the 2024–2025 academic year. 

Accreditation

Temple University’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-SPM-GRAD

Additional Program Information

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