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1. Purpose:
To lay down the procedure for environmental control and monitoring.
2. Scope:
This procedure is applicable for environmental control and monitoring in warehouse department at (Company Name).
3. References & Attachments:
3.1. References: In-house procedure
3.2. Attachments:
3.2.1. Attachment – 1: Environmental monitoring record.
4. Responsibility:
4.1. Maintenance:
4.1.1. To do cleaning and sanitization as per defined procedure.
4.1.2. To check and ensure proper maintenance of AC/AHU to achieve the desired output.
4.1.3. Preventive and breakdown maintenance of utilities as per defined procedure.
4.2. Ware House:
4.2.1. To monitor environmental control as per defined procedure
4.2.2. To ensure cleaning and sanitization as per defined procedure
4.2.3. To ensure proper maintenance of records.
4.3. Quality Assurance:
4.3.1. To ensure the maintenance of environmental control as per the defined procedure.
5. Distribution:
5.1. Quality Assurance
5.2. Production
5.3. Ware House Head
5.4. RMS
5.5. PMS
5.6. Maintenance
5.7. Plant Head
6. Definitions of terms:
6.1. AHU: Air Handling Unit
6.2. A.C: Air Conditioner
6.3. B.M.R: Batch Manufacturing Record
6.4. NMT: Not more than
6.5. RMS: Raw material store
6.6. PMS: Packing material store
7. Procedure:
7.1. Temperature and relative humidity:
7.1.1. Temperature and relative humidity is important from the point of view of,
7.1.1.1. To avoid degradation of products.
7.1.1.2. To ensure comfortable and hygienic working of workmen as per GMP norms
7.1.1.3. To avoid damage to hard gelatin capsule shells.
7.2. Recording of temperature and relative humidity:
7.2.1. The limit for temperature to be maintained at staging areas in warehouse for RM (API, Excipient & Liquids. etc) and PM (Primary) are :
7.2.1.1. Temperature NMT 25 °C
7.2.2 The limit for temperature and relative humidity to be maintained at staging areas in warehouse for EHG Capsule shell are :
7.2.2.1 Temperature 15-30 °C
7.2.2.2 Relative humidity 40-65%
7.2.3 Ambient environment condition to be maintained at staging areas in warehouse for Secondary & Tertiary packing material
7.2.4. Use digital hygrometer for recording of temperature, relative humidity maximum and minimum temperature of last day’s and to record in attachment No.1
7.2.5. Record the temperature and relative humidity of the warehouse and staging areas twice in a day that is once in the morning and once in the afternoon.
7.2.6. The last day’s recorded maximum and minimum temperature to be recorded once in the morning from the digital hygrometer. Then hygrometer to be reset.
7.2.7. Record Temperature and relative humidity in warehouse areas.
7.2.8. Record Magnehelic readings wherever applicable.
7.2.9. In case, the observations are out of specification, immediately stop all activities and inform Maintenance dept for rectification.
7.2.10. Restart processing activities when the Temperature and relative humidity are within limits.
7.2.11. If utility failures more than ten minutes then reset the magnet thermometer.
7.2.12 Temperature monitoring & Data Backup:
7.2.12.1 All controlled storage area/rooms should be equipped with auto recording systems which should record the temperature and/or humidity at every 10 minute interval.
7.2.12.2 Controlled storage area should be equipped with devices that will transmit an immediate alarm to alert personnel in case of any temperature excursion in below listed area/rooms
7.2.12.3 All raw material/finished product storage maintained below 25°c
7.2.12.4 All sensitive raw material/intermediate/finished product storage maintained at 2 to 8 °c, cold storage / Deep-freezer
7.2.12.5 Any excursion (as defined in site respective SOP) that has the potential to impact product quality should be documented and evaluated.
7.2.12.6 The documentation should include the actions taken to assess product impact and to address the equipment failure related to the temperature excursion.
7.2.12.7 Provide temperature alarm with the following requirements unless otherwise justified:
Note: General requirements
> Sensors should be accurate to + 0.5 °C.
> Calibrate devices against a certified, traceable reference standard at least once a year, unless otherwise justified.
> Sensors located to monitor worst-case temperatures within the validated storage volume; where the alarm system is not integrated with the temperature monitoring system, sensors should be located close to the temperature monitoring sensors.
> High/low alarms set points to trigger appropriately located visual alarm(s).
> Preferably there should also be appropriately located audible alarm(s) in addition to the visual alarm(s)
Check functionality of temperature alarms by challenge study at least twice in a year at the designated set points (i.e. High and low temperature)
> All such alarms and temperature recording systems shall be connected to uninterrupted power supply (UPS) system.
> Door opening study shall be performed during qualification
