Reprocessing Procedure

1.0 OBJECTIVE
To lay down a procedure for Reprocessing of batches.
2.0 SCOPE
Module -1,2,3&5
3.0 RESPONSIBILITY
Production Executive.
4.0 ACCOUNTABILITY
Production Manager / QA Manager
5.0 PROCEDURE
5.1.1 If the specified standards are not meeting at granulation stage / pelletisation stage / coating stage or not meeting analytical standards such as Dissolution, Physical appearance, Assay, Moisture content, the Batch will be taken up for reprocessing.
5.1.2 Reprocessing of batch shall be done as per procedure.
5.1.3 An investigation will be done by the concerned production Executive for the reasons and a report will be sent to Formulations Research & Development.
5.1.4 Formulations Research & Development after studying the report shall recommend a reprocessing procedure.
5.1.5 Based on Formulations Research & Development suggestion a process deviation form will be raised by production department for approval . The same deviation should be approved by QA Manager & R &D Manager.
5.1.6 Based on the approved process deviation production department will proceed for reprocessing as per the procedure given by Formulations Research & Development
5.1.7 Process deviation form and recovery procedure will be enclosed with B.M.R.
5.1.8 On the request of Formulations Research & Development, samples will be provided for stability studies as directed by R & D.