In partnership with NUS

Academy of GxP Excellence since 2009

Objective

 

This course covers technologies associated with pharmaceutical and biotechnology processes and different dosage forms. Manufacturing processes and unit operations, facility, personnel, and microbial and quality control requirements will be reviewed with focus for pharmaceutical and biotechnology processes.

 

Description

 

To provide an understanding of different processes that is part of the pharmaceutical and biotechnology facilities. Specific processes will be presented in details along with industry examples.

 

Course Outline

 

  • Sterile Products/Dosage Forms

    • Liquid dosage forms, Semi-solid dosage forms

    • Solid dosage forms (e.g. solid fill, freeze-dried)

 

  • Non-sterile products/Dosage Forms

    • Liquid dosage forms

    • Semi-solid dosage forms- topicals (creams, ointments, gels, etc.)

    • Solid dosage forms (unit dose form (tablets, capsules, suppositories, etc.), multi dose form (powders, granules)

 

  • Biological products Dosage Forms, Vaccines, Blood products, Other (e.g. hormones, enzymes of human or animal origin, genetically engineered products)

    • Dispensing, Granulating, Drying, Blending, Compressing, Coating, Mixing,

    • Material Transfer, Filling, Clean-in-Place, Steam-In-Place

    • Upstream Processing in Biotech facility, Downstream Processing in Biotech facility

    • Media Preparation, Fermentation, Separation, Purification

    • Lyophilization, Filtration, Aseptic Filling

    • Sterilization Processes (e.g. Steam Sterilization Autoclaves, Dry Heat Sterilization, Depyrogenation)

 

Learning Outcome

 

Upon completion of this course the attendees will be able to:

  1. Identify and classify the various dosage forms in pharmaceutical and biotechnology processes

  2. Gain an overview of the key unit operations that make up the manufacturing process of each dosage form (for example, in the case of solid dosage form, an overview of blending, mixing, coating, drying, and tableting steps)

  3. Gain an overview of key microbial and quality control attributes that are related to each dosage form and its unit operations

  4. Learn to apply the knowledge in facility and manufacturing planning, identifying critical points in a process, identifying quality control plan, and identifying the validation plan.

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