Product and pharmaceutical manufacturing assignment
For this Product and pharmaceutical manufacturing assignment, Read the attached article, Manufacturing in the Pharmaceutical Industry, and find 2 additional resources.
With these articles/documents, describe pharmaceutical manufacturing to produce the clinical product.
Select a drug product. Determine the type of drug – biologic, tablet, capsule, etc. VIAGRA IS NOT AN OPTION FOR THIS PAPER.
Fill in the Product Profile template (attached) using the packet insert and other sources as seen in the example.
Write a summary of your product in a separate slide.
The summary must be clear, and convincing and describes product manufacturing supporting development studies. Describe manufacturing challenges and opportunities. Identifies at least 3 types of pharmaceutical manufacturing, to manufacture clinical batches and then upscaling to commercial. Organized and clear; presents strategies, provides justification, solid reasons, and data to support choice. Addresses the complexities and expectations of leading an organization in the development stages. Identifies and describes leadership qualities, organizational style, and impact of culture.
The format of your summary is APA.
Include 4 references
Book: New Drug Development – A Regulatory Overview (New Drug Development ( Mathieu)) 8th Revised Edition
Submit product profile, summary and reference (Fill the page in the summary slide)
ANSWER
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The manufacturing and design of pharmaceutical tablets are a complex multi-stage procedure that requires a proper amount of drug substance in the right form to be delivered at a reasonable rate, at the right time, and in the location while protecting the chemical integrity (Gad, 2008). Tablets are produced through direct compression, wet granulation, or dry granulation. The primary goal of manufacturing pharmaceutical tablets is to formulate tablets that are hard and strong to withstand mechanical shock, that is uniform in drug content and weight, that have good product identity, and that are physically and chemically stable (Rogers & Ierapetritou, 2014).
Ibuprofen is a medication used to relieve pain, fever, and inflammation. It is available over-the-counter (OTC) and by prescription. Ibuprofen is an NSAID (nonsteroidal anti-inflammatory drug), which means it works by reducing inflammation. Ibuprofen tablets are manufactured in various sizes, from 200 to 800 mg. The manufacturing process begins with the active ingredient, ibuprofen, mixed with excipients (inactive ingredients). The mixture is then compressed into tablet form. Tablets are typically coated with a sugar or polymer coating to make them easier to swallow and prevent them from breaking down before they reach the stomach. The manufacturing process for ibuprofen tablets is heavily regulated by the FDA (US Food and Drug Administration) to ensure that the finished product meets strict quality standards.
Pharmaceutical manufacturing is a complex and regulated process. Pharmaceutical companies face significant challenges in quality, cost, and regulatory compliance (Yildirim, Gottwald, Schüler, and Michel, 2016). However, pharmaceutical companies also have significant opportunities to improve their manufacturing processes and operations. Pharmaceutical companies need to ensure quality control throughout the manufacturing process. Pharmaceutical companies must have robust quality control systems to ensure that their products meet these standards. The biggest opportunity for pharmaceutical companies is to improve their manufacturing processes and operations through new technologies and process improvement techniques (Lugovoi, Andritsos, and Senot, 2022).
The complexities and expectations of leading an organization in the development stages of pharmaceutical manufacturing are significant. The challenges faced by those in this position are numerous and varied, from regulatory compliance to ensuring quality control. Leaders must be able to communicate effectively with and motivate their team members. Leading an organization through the development stages of pharmaceutical manufacturing requires a strong leader who can navigate these challenges successfully. The leader must have a strong vision for the organization and link this vision to others. They must also be able to motivate their team members and keep them focused on the task.
Product and pharmaceutical manufacturing assignment: References
Gad, S. C. (Ed.). (2008). Pharmaceutical manufacturing handbook: production and processes. John Wiley & Sons.
Lugovoi, I., Andritsos, D. A., & Senot, C. (2022). Manufacturing process innovation in the pharmaceutical industry. Manufacturing & Service Operations Management, 24(3), 1760-1778.
Rogers, A., & Ierapetritou, M. (2014). Challenges and opportunities in pharmaceutical manufacturing modeling and optimization. Computer Aided Chemical Engineering, 34, 144-149.
Yildirim, O., Gottwald, M., Schüler, P., & Michel, M. C. (2016). Opportunities and challenges for drug development: public-private partnerships, adaptive designs, and big data. Frontiers in pharmacology, 7, 461.
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