Post-Master's Certificate: Sterile Process Manufacturing

SCHOOL OF PHARMACY

About the Certificate

The post-master's certificate in Sterile Process Manufacturing is intended to enable Regulatory Affairs and Quality Assurance (RAQA) students to receive formal recognition for studying the techniques and applicable regulations used in the development and manufacture of sterile products. Sterile products include a wide range of commonly used items, such as intradermal (ID), intramuscular (IM), intravenous (IV), and subcutaneous (SC), as well as vaccines and products administered directly into different parts of the body, such as arteries (intra-arterial), bones (intrasternal), heart (intracardiac), or the spinal canal (intrathecal). Sterile products must be manufactured using aseptic (or free from contamination) methods wherein the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined in a container, such as a syringe. Generally, the final dosage form cannot be sterilized at the end of the manufacturing process since the drug substance would become degraded. Therefore, sterility must be ensured during the manufacturing process by utilizing sterile filtration, microbial controls, and facility design, all of which must follow regulatory guidelines.

Through completion of the certificate, students understand the following:

  • 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.

Time Limit for Certificate Completion: 3 years

Campus Location: Fort Washington

Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

APPLY HERE to the post-master's certificate program.

Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 12

Required Courses:

Core Courses
QARA 5492Production of Sterile Parenterals3
or QARA 5493 Sterilization Processes
QARA 5512Microbiological Concepts in Pharmaceutical Manufacturing3
Electives6
Select two from the following:
Production of Sterile Parenterals 1
Sterilization Processes 1
QARA 5501
Development of Sterile Products
Vaccines: Regulatory Affairs and Quality Assurance Issues
Total Credit Hours12

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/certificate-programs/post-masters-certificates/sterile-process-manufacturing

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Program Coordinator

qara@temple.edu

267-468-8560