SOP for Environmental Monitoring
1.0 OBJECTIVE
To describe the Environment Monitoring in plant.
2.0 SCOPE
This procedure applicable for environment monitoring for manufacturing facility in [company name] plant.
3.0 RESPONSIBILITY
3.1 Head QA – to prepare and implement the Environment monitoring programme.
3.2 Department Head – to implement the Environment monitoring programme.
3.3 QC Department – Sampling, analysis and producing data.
3.4 Engineering Department – support the Environment monitoring Activity.
4.0 PROCEDURE
4.1 Definitions:
4.1.1 Controlled Area: Any area in a process system for which airborne particulate and microorganisms levels are controlled to specific levels, appropriate to the activities conducted within that environment.
4.1.2 Clean Room: A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. In addition, the concentration of microorganism in the environment is monitored.
4.1.3 Premises: Open (non build) area outside the manufacturing facility/building.
4.1.4 Alert Limit: the level that shows a potential drift from normal operating condition. Exceeding the alert limit is not necessarily grounds for definitive corrective action but it should at least prompt a investigation..
4.1.5 Action Limit: the level that when exceeded require immediate follow-up and if necessary, corrective action.
4.2 Qualification of facility/room/area shall include but not limited to monitoring of:
4.2.1 Filter integrity (DOP/ PAO)
4.2.2 Air flow pattern
4.2.3 Air changes
4.2.4 Air pressure/Pressure differentials
4.2.5 Particulate count
4.2.6 Establishing the time required to attain the design room conditions (Temperature, %RH & Particle counts).
4.2.7 Recovery Test
4.2.8 Temperature
4.2.9 Relative Humidity
4.2.10 Microbial Monitoring by settle plate and/or Air sampling.
4.2.11 Surface monitoring (by swab or RODAC) for total Aerobic Microbial count.
4.2.12 Personnel monitoring (by finger dab) for Total Aerobic Microbial Count, E. Coli and Staphylococcus aureus.
4.2.13 Drain monitoring for Total Aerobic Microbial Count.
4.3 Daily Environmental Monitoring in controlled area as per the respective area SOP shall include but not limited to:
4.3.1 Temperature
4.3.2 Relative Humidity
4.3.3 Pressure Differentials.
4.4 Periodic Environmental monitoring in controlled area at pre-determined schedule as per respective area SOP shall include but not limited to:
4.4.1 Filter Integrity (DOP/ PAO)
4.4.2 Air flow pattern
4.4.3 Air changes
4.4.4 Particulate Count
4.4.5 Establishing the time required to attain the design room conditions (Temperature, %RH & Particle counts).
4.4.6 Recovery Test
4.4.7 Microbiological monitoring by settle plate, active air sampling, monitoring, personnel monitoring and drain monitoring, as applicable and appropriate.
4.5 Daily Environmental Monitoring in clean area as per the respective area SOP shall include but not limited to:
4.5.1 Temperature
4.5.2 Relative Humidity
4.5.3 Pressure Differentials.
4.6 Periodic Environmental monitoring in clean area at pre-determined schedule as per respective area SOP shall include but not limited to:
4.6.1 Filter Integrity (DOP/ PAO)
4.6.2 Air flow pattern
4.6.3 Air changes
4.6.4 Particulate Count
4.6.5 Establishing the time required to attain the design room conditions (Temperature, %RH & Particle counts).
4.6.6 Recovery Test
4.6.7 Microbiological monitoring by settle plate, active air sampling, surface monitoring, personnel monitoring and drain monitoring, as applicable and appropriate.
4.7 Environment monitoring of premises at pre-determined schedule shall include but not limited to:
4.7.1 Rodent and pest control monitoring, as applicable.
4.7.2 Effectivity of insectocular lights.
4.7.3 ETP water analysis.
4.8 The environment-monitoring programme shall be covered in Validation master plan.
4.9 The frequency of the monitoring shall comply cGMP and current regulatory requirements.
4.10 The deviation to procedure and specification shall be justified.
4.11 Every activity shall be performed in accordance with approved SOP of Micro section for Environment monitoring of Micro Lab. And Environment monitoring of manufacturing area and RM store..
4.12 The deviation to predetermined programme shall be through planned deviation approved by Head QA.
4.13 To exercise better control on environmental parameter alert limit and action limit shall be defined as appropriate and applicable.
4.14 The alert and action limits shall be based on the trend results. Alert and action limits shall be reviewed on regular basis (suitably yearly) and revised as appropriate and applicable.
5.0 Annexure
Nil