Documentation in Validation Work

It covers pilot plant experiences during scale-up and includes validation-type work.

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.

It is used for new equipment (or altered method of use) as part of change control.

<p>At least three successive batches.</p> Signup and view all the answers

<p>Establishing documented evidence that a process or a system performs and gives results reproducibly and consistently as expected based on a preplanned protocol.</p> Signup and view all the answers

<p>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</p> Signup and view all the answers

<p>Product/process development, Master Documentation File (MDF), Facility development</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers