OBJECTIVE:

• To define a systematic and effective procedure for pest and rodent control within the premises of Caisa Pharma.
•  To ensure the premises remain compliant with WHO GMP hygiene and sanitation requirements.
•  To prevent contamination of products, materials, and documents due to pest activity.

 SCOPE:

• This procedure applies to external and internal areas of the facility, including surroundings, service areas, non-classified areas, and utility zones.
• This procedure covers all pest and rodent control activities carried out by internal personnel or external agencies.

RESPONSIBILITIES:

Human Resource (HR) Department:

• Responsible for planning, coordinating, monitoring, and documenting all pest and rodent control activities.
• To ensure the pest-control agency follows the approved procedure, safety rules, and frequency.
• To ensure pest-control chemicals and methods used are approved and safe.
• To monitor the condition of baits, glue pads, insect killers, and treated areas.
• To maintain all records and ensure they are available for QA review and regulatory audits.
• To report unusual pest activity or deviations to QA for further action.
• To ensure that pest-control activities do not compromise product safety or GMP compliance.

 Quality Assurance (QA):

• To review Pest Control Documents
• To guide in the instances where discrepancies reported.

DEFINATIONS:

• Pest control: Activities carried out to prevent or eliminate insects, rodents, and other pests.
•  Rodent control: Use of baits, traps, and monitoring systems to detect or eliminate rodents.
•  Flying insect control: Use of insect-killing devices or approved chemicals to minimize flying insect activity.
•  Glue pads: Adhesive traps used to capture crawling insects.

PROCEDURE:

General Requirements:

• Only approved pest-control chemicals and devices shall be used.
• All pest-control work inside buildings shall be carried out outside working hours.
• Care shall be taken to prevent contamination during all stages of pest-control activity.
• All personnel involved in pest control shall follow facility entry, hygiene, and safety requirements.

Scheduling and Coordination:

• Pest-control activities shall be carried out as per predefined frequency mentioned in the agreement.
• The external agency shall confirm their visit in advance.
• Coordination with relevant departments shall be ensured before treatment begins.
• An authorized person shall accompany pest-control personnel during the activity.

Disinfestation (General Pest Control):

• Designated internal and external areas shall be treated (once every month) using approved chemicals.
• Sensitive materials and equipment must be protected during spraying.
• Treated areas shall be aired out and made safe before re-entry.
• All activities shall be documented immediately after completion.

Fly Control:

• Fly-control treatment (Once every month) shall be performed to check for rodent activity.
• shall be performed in waste-handling areas and building outskirts.
• Electric insect killers shall be kept functional and cleaned regularly.
• Dead insects shall be removed daily to prevent contamination.
• Records of fly-control activities shall be maintained.

Rodent Control:

• Bait stations shall be placed only in approved external zones.
• Bait stations must remain secured and tamper-proof.
• Regular inspection (Once every month) shall be performed to check for rodent activity.
• Dead rodents shall be disposed of properly by burial, away from water pipelines.
• Rodent-control findings shall be recorded.

Glue Pads:

• Glue pads (non-chemical adhesive pads) shall be placed in identified risk areas.
• They shall be checked daily for crawling insect activity.
• If the pad is 50% filled, it shall be replaced.
• Disposal shall be carried out safely to avoid pest dispersal.
• Inspection it daily and it shall be recorded.

Insect Killers:

• Insect killers (UV light-based units, non-chemical) shall be installed at defined locations.
• Daily checks shall be performed for functioning and cleanliness.
• Dead insects shall be removed and disposal recorded.
• Any malfunction shall be reported for immediate repair.

Chemical Handling:

• Approved insecticidal spray as per pest-control vendor recommendation shall be used for Disinfestation Treatment.
• Only approved chemicals (Food-safe fly-control spray, odorless where required) shall be used for pest control.
• Anti-coagulant rodent baits in pellet, cake, or paste form shall be used for Rodent control.
• Chemicals shall be stored safely and kept closed when not in use.
• Empty containers shall be discarded as per waste-management requirements.
• Quantity of chemicals used shall be recorded for each treatment.

Abnormal Observations:

• Any unexpected or increased pest activity shall be reported immediately.
• Management action shall be initiated based on severity.
• Additional pest-control rounds may be conducted if required.

Documentation:

• All pest-control activity records shall be maintained in controlled form.
• Records shall include, locations treated, chemicals used, findings, and signature of responsible person.
• Records shall be retained as per the document-retention procedure.
• List of Chemical, Frequency as per type of Pest control, precaution needed shall be covered in the Technical Quality Agreement (TQA)

Training:

• All involved personnel shall be trained on this SOP before execution.
• External agency staff shall be briefed on site-specific hygiene and safety requirements.

REFERENCES:

• WHO TRS 986 – GMP Guidance for Premises and Sanitation.
•  Original SOP reviewed from file.
•  Pest-Control Contract Agreement.

 RECORDS:

 REVISION HISTORY.