[ANSWER] HOMEWORK ASSIGNMENT 4 PATHWAY FOR PATIENT HEALTH GLOBAL REGULATORY AND LEGAL REQUIREMENTS OF QUALITY

HOMEWORK ASSIGNMENT 4 PATHWAY FOR PATIENT HEALTH GLOBAL REGULATORY AND LEGAL REQUIREMENTS OF QUALITY

First Name:

Last Name:

Email address:

• Save this file as: First Name Last Name GRLR Project 4 (e.g. Marla Phillips GRLR Project 4.doc)
• Submit this assignment in Canvas
• Assignment due dates are provided in the syllabus
• Generative AI use is not allowed on this assignment.

Assignment:

• Step 1: You will need to listen to the “Failure Investigations” class in order to successfully complete this assignment.  A failure investigation assist document has been provided as a handout to explain the various sections of the failure investigation template.  This was also reviewed during the class recording.

• Step 2: Complete the Failure investigation template provided at the end of this document using the information in the Scenario Section of this Homework Assignment.
  1. In the “Root Cause Investigation” Section of the Investigation Report:
     1. Write at least 5 observations of failure, and why these are viewed as failures to comply with federal regulations and/or GMP expectations (failures to comply with regulations and expectations)
     2. Link the 5 observations to relevant GMP requirements (specific 21CFR211 references). For each of your 5 observations, please list the CFR number and the title of that section, such as “21 CFR 211.100 – Written procedures; deviations”.

• Provide a description of how each observation could be potential sources of contamination and/or risk.

The following table might be useful to help organize your responses related to 2.a. above, but you are not required to use this format.  Put this information, however you organize it, in the “Root Cause Investigation” Section of the Investigation Report:

1. Discuss your thoughts on the possible overall root cause of contamination (physical and microbiological) that increased as the concentration of the API increased. Include this in the “Probable Root Cause” section of the investigation report.
2. Identify possible corrective actions which could be implemented to prevent this type of failure from recurring, and include in the “Corrective Actions” and “Preventative Actions” sections of the investigation report.

Scenario:  Review the scenario and write the investigation (you will need to make-up some of the information however you want, such as Investigation number, Product Name, etc.)

• You have been asked to help a drug facility that has a problem in its manufacturing operations
• Contamination has been identified in the OTC drug product they manufacture
• The contamination, which is both physical and microbiological, increases as the concentration of the API increases
• This has focused the investigation on the manufacturing operations
• The site has sent you a description of how the operators performed the work to add the API to the product

An employee who has been with the company for 20+ years trained an employee on how to add the Active Pharmaceutical Ingredient (API) to the manufacturing equipment that is used to manufacture the final product.

Here is what was observed:

• 2 blue plastic drums are filled with a white liquid, which is the API
  • The plastic drums are loaded onto forklift equipment that allows the employee to tip the drum towards the manufacturing vessel
  • The employee removed the white plastic lid that was well above his head. He removed the lid, tilted