A Robust Process

1) Scenario: A doctor is about to inject an aseptically manufactured injectable finished pharmaceutical into the arm of a child.
a) How would you convince both the patient’s parents and the doctor that the manufacturing process was robust and to proceed in confidence with administration?
The product was produced with a well designed process to reduce the potential for human risk. During product and process development both the inputs and outputs of the process were examine critically to determine the parameters and attributes for the process, the tolerances for those parameters and how best to control them was agreed by the independent team to give most unbiased product to the market. The process was conducted by the set limit arrived upon
(E) Setting Tolerance Limits – Upper and lower tolerances assist in making the critical qualities achieved. So the team came up with these limits to achieve the best results. The defined limits should be practical and selected to accommodate the expected variability of parameters while confirming to the quality attribute acceptance criteria. Development Of A Robust Process:
A systematic team-based approach to development is one way to gain process understanding and to ensure that a robust process is developed. The following are the steps for the development of a robust process:

Team of technical experts, technology transfer, manufacturing, statistical science and other appropriate disciplines. This team approach was to jointly come up with parameters that was to be followed all through. This team allowed smooth operations by setting all the required function and following this help in making the best pharmacy product. This team should be formed before optimization and
Traditional pharmacy compounding provides an important therapeutic option to allow for the creation of individualized drug preparations when a patient’s unique medical needs cannot be met with a commercially available drug. Examples include making dosage forms or strengths that are not commercially available or the removal of certain allergenic ingredients. In such cases, the option of prescribing compounded drugs should remain available for physicians. In traditional compounding, if a preparation error occurs, it would only affect a limited number of patients. Conversely, when pharmacy compounding is done at a large scale in uninspected facilities, using non-validated processes and ingredients of varying quality, an error could potentially affect a large population of patients. GMPs were established by the FDA to reduce the level of risk inherent in the large-scale production of drugs. A comprehensive body of regulations governing every aspect of drug manufacture and testing—enforced through regular FDA inspections—is required to achieve consistent high quality. Setting aside these controls and creating a new class of pharmaceutical manufacturing, done without FDA oversight, is not in the best interests of