Temple University School of Pharmacy 4 courses 12 total credits
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 (i.e., 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.
| Total Credits | 12 credits |
Core Courses
| Code | Course Title | Credits |
|---|---|---|
| QARA 5492 or QARA 5493 | Production of Sterile Parenterals or Sterilization Processes | 3 |
| QARA 5512 | Microbiological Concepts in Pharmaceutical Manufacturing | 3 |
Electives
| Code | Course Title | Credits |
|---|---|---|
| QARA 5492 | Production of Sterile Parenterals | 3 |
| QARA 5493 | Sterilization Processes | 3 |
| QARA 5572 | Vaccines: Regulatory Affairs and Quality Assurance Issues | 3 |
| Total Electives | 6 credits | |
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