Description of the incident:

A deviation was observed in Ranitidine HCl Form-1 Blender room (Block-I clean room)
maximum temperature & humidity on 28/05/2014.
Observed maximum temperature is 26.7C against to the specified limit not more than 25C. The
temperature was observed as 26.7C and
Humidity was observed as 90% RH against the specified limit not more than 50%RH.
Investigation and Conclusion:
Based on the investigation it is concluded that, chiller (which is being supplied chilled water to
clean room related AHUs) was not performed well and not given full TR on that day. Due to this
reason temperature was increased to above the specified limit >25C.
Based on Long term stability data (temperature at 252C & 655% of RH) of Ranitidine HCl
Product there is no impact on the Ranitidine HCl product quality due to this high temperature &
High humidity.
Impact assessment: Upon observing the deviation in Temperature and in Humidity, the ongoing
operations in blender room were stopped and the material was kept in closed container to avoid
exposure. The quality of the neighboring batches were reviewed and found well within the
specified limits.
Correction:
As an immediate measure brine supply was provided to AHU to control the temperature &
Humidity within the range. All the operations were resumed after getting the temperature &
humidity under control.
Corrective action & Preventive action:
Cleaning schedule for VAM Condenser was prepared for every 3 months with reference to
notification 200085486 and CAPA notification No
200097111 and has been implemented.
P00011677
Temperature & Humidity variation B-Block
200104211