HCR 576 Module 6: Group Assignment: Mock PLI/PAI Report for a Manufacturing Facility Group Project
HCR 576 Module 6: Group Assignment: Mock PLI/PAI Report for a Manufacturing Facility Group Project
- Due Oct 2 by 11:59pm
- Points 150
- Submitting a file upload
- Available Aug 28 at 12am – Oct 3 at 11:59pm
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Learn about Pre-Approval Inspection (PAI), including what it is, why it’s important, when it happens, how to prepare, and the different possible outcomes.
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Tablet manufacture refers to the production of tablets and iPads, which are increasingly used in pediatric care, necessitating adaptations for users with dexterity impairments. These adaptations, such as the Hand Glider and Faraday Stylus, are created to enhance accessibility for individuals with upper extremity impairments. AI generated definition based on: Pediatric Hand Therapy, 2020
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The PAT framework intends to make effective use of state-of-the-art pharmaceutical science and engineering principles and knowledge throughout the life cycle of a product to improve the efficiency of both manufacturing and regulatory processes, and to achieve this by using an integrated systems approach to regulate product quality. The desired state of pharmaceutical manufacturing as defined …
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<p>Pharmaceutical companies are governed by regulations and thus regulatory inspection management is very important for pharmaceutical companies. They must follow the regulations and/or regulatory guidelines of the country where they are authorized to sell their products. Generally, the regulatory authority inspects the manufacturing site of the pharmaceutical company before giving a …
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This article provides an overview of some of the most essential elements to consider when designing a pharmaceutical production space.
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Prefilled syringes are well-established for delivering complex biologics. Learn about the challenges they pose for syringe fill-finish manufacturing.
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Deep dive into sterile injectables! Explore production methods (aseptic vs. terminal sterilization), quality control & partner considerations for safe & effective drugs.
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This document discusses the manufacturing of liquid dosage forms. Liquids can be monophasic, containing a single phase, or biphasic, containing two immiscible phases like suspensions and emulsions. Key components include active ingredients, vehicles, surfactants, preservatives, colors, and flavors. Manufacturing involves accurately measuring and mixing components according to their solubility …
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- Due Oct 2 by 11:59pm
- Points 150
- Submitting a file upload
- Available Aug 28 at 12am – Oct 3 at 11:59pm
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Criteria
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Ratings
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Pts
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This criterion is linked to a Learning OutcomePresentation
Demonstrates knowledge of topic
Slides/notes are not read Demonstrates linkage to other related topics |
50 ptsFull Marks
0 ptsNo Marks
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50 pts
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This criterion is linked to a Learning OutcomeFormat
9-12 words per line
Readable graphics Combination of narrative and graphics Drug name Description of PAI References APA format |
20 ptsFull Marks
0 ptsNo Marks
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20 pts
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This criterion is linked to a Learning OutcomeSummary Report
page summary of presentation with a clearly articulated hypothesis, conclusion and recommended next steps.
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65 ptsFull Marks
0 ptsNo Marks
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65 pts
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This criterion is linked to a Learning OutcomeSummary report format
APA format, spelling, grammar, references – 1 MUST be from ASU library
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15 ptsFull Marks
0 ptsNo Marks
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15 pts
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Introduction
Preparing for a Pre-License Inspection (PLI) or Pre-Approval Inspection (PAI) is one of the most critical milestones in pharmaceutical manufacturing. These inspections serve as the FDA’s final verification that a facility, its processes, and its quality systems meet regulatory requirements before a product can be approved for market release. For our group project, we are tasked with simulating the steps a company must take to ensure inspection readiness while aligning production timelines with regulatory expectations. This assignment provides an opportunity to integrate our knowledge of pharmaceutical manufacturing, facility design, inspection management, and regulatory frameworks into a cohesive plan that reflects real-world industry standards.
Our mock PLI/PAI presentation focuses on developing a structured checklist, identifying subject matter experts (SMEs), and preparing an inspection-ready room to facilitate effective communication with FDA inspectors. Additionally, we will summarize the key elements of our drug manufacturing process and anticipate the primary topics FDA reviewers are likely to evaluate during their visit. Through this exercise, we aim to demonstrate not only technical and regulatory knowledge but also the critical importance of preparation, organization, and proactive quality assurance in ensuring successful inspection outcomes.
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