STANDARD OPERATING PROCEDURE Title: Temperature/Humidity Daily/Weekly Record

1. PURPOSE

• It is established Humidity & Temperature.

2. SCOPE
• It is applicable to Q.A Department.

3. RESPONSIBILITY
Procedure:
• Readout the dry bulb reading of hygrometer.
• Also readout the wet bulb reading of hygrometer.
• Subtract the wet bulb temperature from dry bulb temperature and note the humidity by taking the difference in humidity chart in contrast with dry bulb reading.

LIMITS:
Section HUMIDITY TEMPERATURE
Dry Injection NMT 40% 30 oC
Controlled Room NMT 50% 25 oC
Capsules NMT 45% 30 oC
Dry Suspension NMT 45% 30 oC
Tablet
(In case of Ranitidien) NMT 50 %
NMT 40% 30 oC
30 oC
Powder NMT 36% 35 oC


4. QUALITY RECORD(s)/FORM(s)
The following Quality Records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12).

Required Record Form Reference No.
Temperature /Humidity
Daily /Weekly Record QF/005/01