Capa case study

QUAL54111 Case Study/Simulation: CAPADuring 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 December 3, 2023 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 between 500 – 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 & Grammar (2 marks)
References (2 marks)
Total Marks=20 marks