Microsoft Word - ex 11 & 12.docxPage 1 of 1 Exercise 12 Consider the following situation. Make use of FMEA to evaluate the risk to the patients and the company. (20) Your...

Please refer to the attachment.

Perform a Failure Mode andEffects Analysis (FMEA) risk assessment to determine the risks :

Does a small number of potential low fill or empty capsules in a single batch of Eplic®capsules pose an unacceptable risk to (i) patients, and (ii) to the company?

Microsoft Word - ex 11 & 12.docx Page 1 of 1 Exercise 12 Consider the following situation. Make use of FMEA to evaluate the risk to the patients and the company. (20) Your company manufactures Eplic® capsules. Eplic ® is used for the treatment and control of epilepsy. The capsule is an orange opaque capsule which contains 80 mg of active and should be taken twice daily with meals to control and prevent epileptic fits. Multiple customer complaints of empty capsules were received. Lot A12B was fully distributed in South Africa and no product remains within company control. There is no evidence of tampering. Upon review of the batch record it was found that a loose dosator pin was replaced on the encapsulation machine. Following replacement and prior to resuming encapsulation, acceptance testing of capsules produced required by Standard Operating Procedure was performed and product met requirements. Further investigation revealed that the loose dosator caused empty capsules to be produced. The encapsulation system utilized a vacuum system to remove empty capsules. This empty capsule removal system includes a reservoir for holding empty capsules rejected during the manufacturing process. As a result of the loose dosator, an atypically high number of reject empty/low fill capsules were produced during the encapsulation operation, causing the reservoir to be filled and eventually overflow. The reservoir was physically located over the acceptable capsule flow. Therefore, it was determined during the investigation that if the empty capsule chamber overflowed, there was potential for rejected capsules fall back into the acceptable capsule exit chute and be reintroduced to the lot. Sealed bottles were obtained from retained samples of the lot. Of 310 capsules examined, 31 empty and 3 low fill weight capsules were found. Between one and three empty capsules were found in 15% of the bottles which were evaluated. Risk Question: Does a small number of potential low fill or empty capsules in a single batch of Eplic® capsules pose an unacceptable risk to (i) patients, and (ii) to the company? Perform a Failure Mode and Effects Analysis (FMEA) risk assessment to determine the risks