Microsoft Word - ex 11 & 12.docx
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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
esult 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
eservoir 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
ottles 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