Question

GMP Case Study Scenario
You are the quality control (QC) manager for a relatively new company that conducts manufacturing operations under contract to pharmaceutical companies. Your company’s facility handles rDNA protein products made in fermentation processes, followed by downstream purification steps, as well as and all testing. The facility was inspected in 2015 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 of nine amino acids with no glycosylation (no carbohydrate substitutions). SuperPharma want the new process running in one month and your management has agreed to the timetable.
As QC manager, you are responsible for overseeing all steps performed by your staff to ensure that the 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 (2) a purity test at release of the active ingredient – this is not a method you currently perform.   There are also two new components used in the fermentation medium.
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.

6. What actions could or should you take to ensure your company produces a high quality product and stays within GMP requirements?

Answer 1

GMP or Good Manufacturing Practices are standards that pharmaceutical products must conform to,and it ensures sustaining quality and providing credibility to the new products.

SuperDrug-100 also should be manufactured in a consistent manner complying by the GMP rules, so that failure rates are minimal. SuperDrug-100 would have to comply by manufacturing guidelines under GMP, which include operations involving receipt of materials, packing and repacking,storage and distribution of the APIs.Batches of SuperDrug-100 made by the process should be consistent and homogenous, and be in specified ranges.

Good Microbial Techniques , developed in collaboration with WHO should be followed, esp. since fermentation is used in production. Towards purification and packaging of SuperDrug-100, the GMP stringent requirements should increase further. Establishment and maintanence of a cell bank is crucial ,followed by steps of adding cells to the fermentation media,

At each stage observation and results should be clearly documented to troubleshoot, as in instances of detecting impurities in the product/SuperDrug-100 beyond a specific limit, such that anomalies can be traced to starting aterial or any other subsequent step.The process should be recalibrated then.