Change control management Process

Identifying type of change

Concerned person shall, identify type of change based on need for change i.e. Temporary change or Permanent change. 

Temporary change

A temporary change shall be initiated  either  for a particular identified batch, on need basis or in accordance with the  permanent change Control procedure  for the study  of impacts  on batches. Before implementation of the proposed changes and to collect the data for the evaluation of proposed change . The recommendation of  Possible Impacts shall be complied  before the closing of  temporary change  procedure or to proceed further to Permanent change procedure.

Permanent change

A permanent change shall be initiated  with a vision of change in procedure  either with a backup of minimum three batches data with satisfactory results or  for the direct change (e.g. batch size increase for selected batch or batches) or with a recommendation of  competent authority. 

The permanent change shall be  followed by the recommendation of impacts, which shall be  complied  before the closing of change control procedure.     

Procedure for Change Control
Concerned person shall collect the change control form from the Quality Unit and fill the following necessary details of format such as
1 Existing Process for change will be done
2 Proposed Process for Change
3 Rational or Justification, why the change control to be initiate (e.g. to improve the quality of product, better control on product quality with proposed changes, recommended by regulatory bodies etc)

Filled change control & supporting proposed documents shall hand over to concerned department head for initial review, comment and acceptance of change. Then hand over to QA for Impact evaluation and approval.

After QA approval, impacted documents need to revised and change shall be implemented. QA shall review the implementation status in post review of change control for accuracy, correctness and impact of change with summarized results of batches or documents.