Pharmaceutical Manufacturing Primer

Pharmaceutical Manufacturing Primer

*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.

Biotech Primer’s NASBA Profile

Optional CPE Credit: 1.0

Overview:

Pharmaceutical Manufacturing Primer covers essential aspects of small molecule drug production. It begins with the unique ingredients incorporated into these medications, emphasizing the roles of active pharmaceutical ingredients (API) and excipients. Various chemical synthesis methods are demonstrated, including organic, linear, convergent, and stereoselective approaches. The intricate purification process and stringent regulatory aspects of API production are explained, along with supplier validation requirements. This foundational class continues with formulation goals and dosage form characteristics, such as tablets and capsules. It ends with a deep dive into packaging considerations, highlighting fill and finish methodology, regulations, tamper resistance measures, anti-counterfeit technologies, and supply chain management, including cold chain logistics.

• Section 1: Chemical Synthesis: Learn the types of reactions used to synthesize the active pharmaceutical ingredients (API).
• Section 2: Purification: Learn the purpose of each API purification method and how supplier validation ensures manufacturing quality.
• Section 3: Formulation: Learn the key formulation goals and the characteristics of the four most common pharmaceutical formulations: tablets, capsules, suspensions and emulsions.
• Session 4: Packaging: Learn the purpose, methods, and regulations of fill/finish, packaging, chain supply, shipping validation, and anti-counterfeiting technologies.

By the end of the course, participants will be able to:

1. Diagram the essential stages involved in the production of small molecule drugs. 
2. List the primary components that constitute a small molecule drug and state the functions of each. 
3. Clarify regulators’ methods to guarantee quality control during supplier selection, production, packaging, and shipping validation. 
4. Explore the similarities and differences between the four prevalent forms of pharmaceutical formulations: tablets, capsules, suspensions, and emulsions. 
5. Detail the factors to be considered in the pharmaceutical supply chain, including measures to prevent drug tampering and counterfeiting.

LEARN MORE

Use the promo code BIONTX15 at checkout to receive 15% off