Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company.
Quality assurance and regulatory issues in pharmaceutical manufacturing. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, and health, safety, & environment concepts. Regulatory and legal overview.
Topics Covered Include:
- Introduction to Pharmaceutical Manufacturing Industry including regulatory compliance, GMP, QA and validation issues
- Active Pharmaceutical Ingredient Chemical Process Technology
- Biochemical Process Technology including special unit operations and drug delivery systems
- Aseptic Pharmaceutical Manufacture including filtration and sterilization methods
- Simple Solution Systems including solubility, stability and organoleptic considerations
- Semi-Solid Dispersed Systems including mixing, homogenization and rheological considerations
- Pharmaceutical Encapsulation Operations
- Pharmaceutical Compaction and Compression Operations
- Pharmaceutical Coating Operations
- Special Pharmaceutical Operations including Micronization, Lyophilization, Aerosols & Form-Fill-Seal Operations
- Pharmaceutical Packaging Operations
- Preparing for FDA Inspection, including documentation, training, health, safety & environmental concerns
