+1 862 207 3288 Essay, Biology
case study
GMP Case Study Scenario
You are the quality control (QC) supervisor for a relatively new company that conducts
manufacturing operations under contract to pharmaceutical companies. Your company’s
facility handles fermentation products, downstream purification steps, and all testing. The
facility was inspected in 2009 to local current good manufacturing practice (GMP)
standards.
The ongoing contract you have with SuperPharma P/L has entered a new phase.
SuperPharma are providing a second generation production process, following on from the
findings of their own R&D group. The product is SuperDrug-100, which is a small peptide
made up a nine amino acids with no glycosylation. SuperPharma want the new process
running in one month and your management has agreed to the timetable.
Part A
As QC supervisor reporting to the QC manager, you are responsible for implementing steps
to ensure that all tests associated with the changes in manufacturing SuperDrug-100 are
introduced, performed and recorded appropriately in your lab. You were sent a memo
stating that two completely new tests have been introduced: (1) an in-process test after
the fermentation step and (2) a purity test at release of the active ingredient. The purity
test is not a method you currently perform. Four new raw materials are used in the
modified fermentation process, two from sources that you have not used before.
QUESTIONS: As QC supervisor in a GMP facility, what documents would you recommend to
the QC manager to be needed in making changes to an existing project in the QC lab? How
would you handle the new raw materials and test methods? How would any changes get
approved?
Part B
You are also responsible for technical review of the SuperPharma R&D analytical findings,
on which the modified process has been based. Some of their analytical assays show a
slightly changed profile with regard to total impurities, and their assays are not validated
in R&D. You are concerned that the quality of the material from the modified process
might not be equivalent to the earlier batches. However, the product specifications have
not been changed, and the new R&D materials are claimed to pass the original set of tests
with the same limits as before, but the limits are very wide.
QUESTIONS:
What are the first steps to take in investigating the situation about purity
profiles? How could you eliminate concern that the very minor change in the impurity profile
might be significant, since it appeared from the R&D reports that the scale-up work went very
smoothly? What actions could or should you take to ensure your company produces a high
quality product and stays within GMP requirements?
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