PHM 5150 Dosage Forms and Considerations in Industrial Pharmacy Assignment Task
Assignment Details:-
- Topic: Industrial Pharmacy
- Words Count: 2000-2500
- Citation/Referencing Style: APA Citation
- Academic Standard Level: University Degree
- University: Levy Mwanawasa Medical University
Are you searching for assignment answers online? AssignmentTask experts assist you with your PHM 5150 Dosage Forms and Considerations in Industrial Pharmacy Assignment Task Questions. Avail affordable medical/nursing assignment help from PhD writers. We assure you that we deliver assignment writing help online with 100% plagiarism-free work. Students can also avail of our best university assignment help to upgrade your academic scores. Ask your query to the 24/7 live chat support team for assignment help.
Objective
The objective of this assignment is to provide you with a comprehensive understanding in dosage form development and considerations in industrial pharmacy settings. Through this assignment, you should gain hands-on experience in formulating, manufacturing, quality control, and regulatory aspects of various dosage forms encountered in the pharmaceutical industry.
Assignment Overview
You have been assigned a specific dosage form to work on independently.
Dosage Forms Assignment Tasks:
- Formulation Development:
- Conduct a literature review on formulation considerations specific to the assigned dosage form.
- Design a formulation recipe considering the physicochemical properties of the active pharmaceutical ingredient (API) and excipients.
- Justify the selection of excipients based on their functionality and compatibility with the API.
- Manufacturing Process:
- Develop a step-by-step manufacturing process for the assigned dosage form.
- Identify critical process parameters and justify them.
- Design a manufacturing flowchart illustrating the sequence of operations involved in producing the dosage form.
- Think of potential challenges and strategies on how to overcome them during the manufacturing process.
- Quality Control and Assurance:
- Establish specifications for key quality attributes of your finished dosage form.
- Prepare a quality control plan outlining the sampling, testing, and acceptance criteria for each quality attribute.
- Think of strategies for ensuring compliance with Good Manufacturing Practices (GMP) during the manufacturing process.
- Regulatory Considerations:
- Identify relevant regulatory guidelines and requirements governing the manufacturing and marketing of the assigned dosage form.
- Discuss what documentation you think a regulatory submission dossier for your dosage form should contain to obtain regulatory approval.
- Discuss the regulatory implications of any novel excipients or formulation approaches used in the dosage form.
- Outline what post-approval regulatory commitments or ongoing compliance may be required for your dosage form.
Prepare a report which should cover all aspects of the assignment, including:
- Introduction on the dosage form provided.
- Formulation development based on the task above
- Manufacturing flow and process on the task above
- Quality control established on the task above, and
- Regulatory considerations.
- References used.
Evaluation Criteria
You will be evaluated based on the following criteria:
- Clarity and completeness of the formulation design and manufacturing process.
- Accuracy and robustness of the quality control plan.
- Thoroughness of the regulatory assessment and compliance strategy.
- References and introduction
Finding for Reliable Assignment Assistance? Checkout Our Free Assignment Samples from Professionals.
