OBJECTIVE:

• This Standard Operating Procedure shall describe the method for monitoring, recording, and controlling temperature, relative humidity (RH), and differential pressure (DP) in manufacturing, packing, and warehouse areas to ensure compliance with WHO GMP requirements for tablet manufacturing facilities.

SCOPE:

• This SOP shall be applicable to, Tablet manufacturing areas, Primary and secondary packing areas, Raw material, packing material, Quality Control Laboratory, hold areas, Dispensing Areas and finished goods warehouses

RESPONSIBILITIES:

User Department:

• User department shall ensure that environmental conditions are monitored and recorded as per this SOP.
• The operator or production designee shall maintain the environmental monitoring records.

Engineering Department:

• The Engineering Department shall maintain Heating, Ventilation and Air Conditioning (HVAC) systems in operational condition
• Shall attend to any environmental deviations.

Quality Assurance (QA) Department:

• The QA Department shall review environmental monitoring records.
• Shall evaluate deviations and Corrective and Preventive Action (CAPA).
• To issue the Records to user departments.

DEFINATIONS:

• Environmental Monitoring: Environmental monitoring shall mean the routine monitoring of temperature, relative humidity, and differential pressure.
•  Operational Area: An operational area shall mean an area where manufacturing, packing, or material handling activity is being performed.
•  Non-Operational Area: A non-operational area shall mean an area where no manufacturing, packing, or material handling activity is being performed at that movement.

PROCEDURE:

Environmental Parameters and Limits:

• Manufacturing, and Packing areas:

•  Warehouse Areas (RM / PM / FG):

 Cold Storage Areas:

• Environmental conditions shall be maintained as per the area and product storage requirements.
• Cold storage temperature shall be monitored continuously or recorded at defined intervals as per approved procedure.
• Temperature, relative humidity, and differential pressure shall be monitored using calibrated instruments such as Calibrated digital hygrometers, and Calibrated magnehelic gauges or DP transmitters.
• The operator or production designee shall record temperature, relative humidity, and differential pressure in the approved environmental monitoring format.

Frequency, Recording Interval and Timing:

• Environmental parameters shall be monitored and recorded thrice per shift in manufacturing, packing, Quality Control and warehouse areas.
•  The minimum interval between two consecutive recordings shall be not less than four (4) hours.
• The recommended recording timings shall be:

First entry: At the shift beginning

Second entry: At Mid-shift

Third entry: End of the shift

• Differential pressure shall be checked and recorded at the same frequency as temperature and relative humidity.
• Any reading found beyond specified limits shall be immediately informed to QA and Engineering.
• The affected area and duration of incident shall be identified.
• If the Environmental Condition Excursion Duration is less than 15 minutes No incident shall be raised, provided conditions are restored automatically and no product is exposed.
• If the Environmental Condition Excursion Duration is more than 15 minutes and less than 60 minutes, Impact assessment shall be documented; incident may not be required if justification is adequate.
• If the Environmental Condition Excursion Duration is more than 60 minutes, incident shall be raised.
• QA shall assess the impact of the deviation on product quality.
• Short fluctuations occur during HVAC cycling, door movement, or power transition and are considered acceptable.

Procedure for Non-Operational Areas:

• When the area is not operational, environmental conditions shall not be required to be maintained.
• In such cases, the operator or production designee shall record “No Activity” in the environmental monitoring record against the particular date / shift
• The operator or production designee shall sign and date the record confirming that no activity was performed in the area.
• No temperature, relative humidity, or differential pressure values shall be recorded during non-operational periods.

Training and Document retention:

• All personnel involved in the activity shall be trained in this SOP.
• Documents shall be retained fiver years or one year after product expiry whichever is higher.

REFERENCE:

• EU-GMP Guide, Chapter 1 & Chapter 3
•  WHO Technical Report Series (TRS) No. 986, Annex 2 and WHO Technical Report Series (TRS) No. 961, Annex 6
• ICH Q9 (Quality Risk Management)

RECORDS:

 REVISION HISTORY: