Temporary change control

Temporary change control is changing in the approved procedure on temporary basis after risk analysis and evaluation cross functional team, which activity consider in planed deviation ,it shall be covered in temporary change control,  It shall be carried out in following but not limited to:

1. Any departure from the approved written procedure for short duration then turn to temporary change control 
2. Temporary change control can be taken for proposed change in location / area, change in equipment(s) to be used, change in packaging material etc.   
3. Change in packing & manufacturing line which are identical,
4. Consumption of Old packing material,
5. Change in packing material shade as per approved specification. 
6. Use of packing material if not impacting on product quality.
7. In case of process changes, Temporary change control shall be approved only, when supported by the laboratory data/ relevant data trend.
8. The initiator of temporary change control shall write about the temporary change related to equipment / Process / documentation or any other. The temporary change control shall include information related to the change in plan, standard practice and reason for change.
9. The temporary change proposal shall then be evaluated and commented by concerned department HOD.
10. All temporary change control shall be supported by a time frame for completions of activity related with the closure of temporary changes,this shall be not greater than 30 days from the approval of temporary change control. 
11. However, in cases where, the temporary change control required data, which may be extended beyond the stipulated closure time with adequate justification.
12. The Temporary change control shall be forwarded to Quality unit for further evaluation. Quality unit shall review the temporary change control for acceptability and impact on product quality, Process performance and previous history of changes.
13. Any similar temporary change control in past and In case of repeated temporary change control, permanent change control shall be taken to make the change permanent.
14. In case of contract giver product Temporary change control shall be forwarded to contract giver for their approval /comment if required.
15. Based on the impact of the proposed temporary change control , Head-of quality unit shall assign the class of temporary change as  Major, Moderate or Minor and approve / reject the same depending on the nature & degree of change. Major & Moderate temporary change control not acceptable.
16.  Based upon the repetition of the temporary change control and their assessment, Quality unit shall decide for applicability of the change in the facility / system through the permanent change control procedure.
17. If the proposed Temporary change control and the justification are found acceptable, then Quality unit shall give recommendations, suggest alternatives and propose corrective actions. This might lead to additional testing(s) / precaution(s). 
18. In case of minor Temporary change control CAPA shall be closed within the format. if three similar temporary changes, Permanent changes shall be done through permanent change control procedure.