hw 11

Upon reading chapter 7 of the main text book on “Quality Control”, please POST your answers for the following questions in this Discussion Forum.

Your firm, RPX Pharma, has successfully tested a recombinant protein candidate for bone growth indications in clinical trials.  The FDA will send a team to your manufacturing site for pre-market inspection.  As the head in QC, you will work with your team members to prepare for the site visit.  Please address the following questions, so that the inspection will be successful.

1) Describe quality control test schemes that have been used to produce bio-pharmaceuticals of a similar molecular nature.  Identify regulatory guidelines which apply to the QC of such products.

2) Define and justify the attributes of final product as they are based on its known nature and the intended manufacturing scheme for final product.  Once the attributes are listed, draft a Certificate of Analysis, adding analytical methods and specifications to the proposed attributes and tests.

3) Describe in-process samples that will be taken during the manufacturing process, and identify attributes, tests, and possible specifications for each sample.

4) Describe what is known about the specificity, accuracy, precision, range, and robustness of two of the QC assays to be used.  Please justify the need to develop the assays and the control reagents or reference standards for the assays.

5) Identify which analytical tests will be qualified, verified, and validated, and describe the most likely point in the development cycle of each activity.