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.

1. As QC manager in a GMP facility, what documents would you require to make changes to an existing project in the QC lab?

Answer 1

Following will be re required by the QC manager to make changes to the existing project:

1. A set of guidelines to make the changes maintaining the standards required for the facility.

2. Validation and assessments of procedures for quality check, data, purity confirmation, and system up gradation.

3. Evaluation system and report structures for audit to ensure the changes in the existing structure.

4. Formation of guidelines to carry out any such changes in the future by an independent team after the careful assessment of the current procedures.