QUAL54111 Case Study/Simulation: CAPA During class, we discussed a warning letter issued to Glenmark Pharmaceuticals Limited due to inadequate corrective action/preventive action (CAPA) procedures. For this case study, refer to the warning letter via the link below, and focus on item (b) as shown in the box below which was communicated to Glenmark Pharmaceuticals Limited by the FDA: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmarkpharmaceuticals-limited-582701-10032019 Item (b): You failed to adequately investigate multiple temperature excursions that occurred during shipping of your drug products. Your investigations into the temperature excursions did not include timely actions to prevent their recurrence. For example, in May 2018, (b)(4) cream USP, (b)(4)% batches were exposed to temperature excursions up to (b)(4)°C and (b)(4)°C for (b)(4) while in transit to the United States. (b)(4) cream should be stored between (b)(4)°C. In July 2018, a (b)(4)USP, (b)(4)% batch was exposed to (b)(4)°C for (b)(4) while in transit to the United States. (b)(4) should be stored between (b)(4)°C. These (b)(4) batches were distributed to the U.S. Inadequate investigation into temperature excursions is an ongoing issue and was a deficiency cited during the previous inspection of your facility. Notably, you performed a study to determine the impact of elevated temperature on (b)(4) cream USP, (b)(4)%. The study showed phase separation of the product at (b)(4)°C. In your response, you stated that you will perform an additional temperature excursion study as well as conduct a longterm stability study. You also stated that you will investigate all confirmed out-of-specification (OOS) results during the temperature excursion studies and will notify the FDA, as appropriate. Your response is inadequate. You did not provide an adequate risk assessment for marketed batches exposed to temperatures outside the labeled storage conditions. Also, your response mentioned the implementation of new shipping practices to protect your products from thermal excursions, but they were not implemented in a timely manner. Due Sunday March 24, 2024 before 11:59PM Reflect on item (b) and select one of the three topics below that is of interest to you to propose a CAPA: 1) The company failed to investigate temperature excursions which occurred during transit to the US on multiple occasions. 2) The company failed to implement new shipping practices to protect products from temperature excursions in a timely fashion. 3) Temperature excursions keep occurring during transit of drug products from India to the US. In a single document that is less than 1000 words, double spaced, 12 point font, include your responses to the following: i) ii) iii) iv) v) Propose the root cause contributing to this non-conformance (4 marks) Propose one corrective action to address this non-conformance (4 marks) Propose one preventive action (4 marks) Discuss how you will evaluate whether the CAPA you propose is successful in eliminating the root cause of the issue. (2 marks) If you created an SOP to improve processes to prevent non-conformance, what type of change control would this be and what are the requirements for reporting such changes to Health Canada? (2 marks) Spelling