10 Questions
What does the General technical report (GTR) cover?
It covers pilot plant experiences during scale-up and includes validation-type work.
What is the purpose of the Report to pilot plant (RPP)?
Covering the R&D experiences of the formulation department, including the history of product development, formula and manufacturing directions used at a laboratory scale, and the results obtained from product testing and stability studies.
What does the Revised RPS document address?
It is used for new equipment (or altered method of use) as part of change control.
How many successive batches should the validation work during scale-up be performed on, according to the text?
At least three successive batches.
What is the purpose of the Prospective validation?
Establishing documented evidence that a process or a system performs and gives results reproducibly and consistently as expected based on a preplanned protocol.
What are the steps of prospective validation?
Qualifications of systems and subsystems, IQ, OP, PQ, calibration of instruments, approval of validation protocol, protocol execution, analysis of results in a task report, approval of a task report conclusions
What is the prerequisite structure for the prospective validation process?
Product/process development, Master Documentation File (MDF), Facility development
What is the purpose of concurrent (on-going) validation?
To establish documented evidence that a process performs and gives results reproducibly and consistently as expected, based on information generated during actual implementation of the process.
What is the definition of retrospective process validation?
Establishing documented evidence that a process will perform and give results reproducibly and consistently as expected, based on information gained from review and analysis of historical data from previously processed batches.
When is retrospective process validation used?
It can be used to augment the initial premarket prospective validation for new products or changed processes, and for products already in distribution without sufficient premarket process validation.
Test your knowledge of the various types of documentation required during validation work, including the Report to Pilot Plant (RPP) and General Technical Report (GTR). Explore the history of product development, formulation, manufacturing directions, product testing, stability studies, and more.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
