To lay down the procedure to control pest & rodent within the plant.
This SOP is applicable for pest & rodent control within the plant and the factory premises at pharmaceutical company.
GMP Coordinator shall be responsible for monitoring the activity.
QA Head shall be accountable for the implementation of this SOP.
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No. : Number
GMP : Good Manufacturing Practices
QA : Quality Assurance
ID No. : Identification No.
E.g. : Example
& : And
i.e. : That is
6.1 Pest Control
6.1.1 All pest control activities shall be performed by outside pest control agency.
6.1.2 Annual contract shall be done with outside pest control agency.
6.1.3 The pest control activity shall be performed on weekly basis.
6.1.4 Only contractor’s trained person shall be allowed for conducting the pest control activity.
6.1.5 The area and the pesticide points shall be mentioned as per Annexure-I i.e. ‘Pest Control Records’.
6.1.6 The person, who shall be involved in pest & rodent control activity, shall be trained and must wear proper gown, nose mask, hand gloves & shoe cover.
6.1.7 In case of any seasonal affect in environment / climatic change due to which there is increase of insects, flies, etc., additional services shall be taken from contractor & record should be maintained thereof.
6.1.8 Record shall be checked by GMP Coordinator.
6.1.9 Storage of pesticide shall not be permitted in manufacturing premises.
6.1.10 Only emulsifiable concentrate (EC) grade pesticides with known antidote shall be allowed to use as per Annexure-III.
6.1.11 Reliability of pesticides shall be checked by contractor while procurement along with material safety data sheet.
6.1.12 Issue, preparation, use and safe disposal of pesticide container shall be the responsibility of contractor’s person, which must be done by them at their end.
6.1.13 Ensure that the area shall be free from medicament related components during and after the pest control till it is cleaned by housekeeping and permitted by QA for operation.
6.1.14 Ensure that pest control activity shall be done as per Annexure-I and record shall be maintained by GMP coordinator after review from QA Department.
6.1.15 Ensure the cleaning of each pest-controlled area for absence of pesticides by GMP Coordinator.
6.2 Rodents Control
6.2.1 The “Glue pad” shall be placed inside the roda box for controlling the rodents by the contractor’s trained personnel fortnightly and record shall maintain in Annexure-II.
6.2.2 The roda boxes shall be identified by a unique number on the basis of their location e.g. RB01
6.2.3 Where R stands for rodent
B stands for Box
01 stands for serial number.
6.2.3 Roda boxes location & ID no. shall be as per Annexure-II.
6.2.4 In house inspection of roda boxes shall be done by housekeeping personnel twice in a week in supervision of GMP coordinator, records of verification shall be maintain accordingly as per Annexure-II.
6.2.5 During inspection if any rodent shall observed than housekeeping personnel shall clean the roda boxes and place another glue trouble gum pad.
6.2.6 Rodent shall bury and records shall maintain in Annexure-II
6.3 Insects Control
6.3.1 For controlling the insects, insectocutor shall be placed at each entry point and wherever necessary.
6.3.2 All insectocutors shall be numbered with a unique identification no. e.g. IS01, where IS represent the insectocutor and 01 represents the sequential serial no.
6.3.3 A list of insectocutors with ID no. & location shall maintain as per Annexure-V
6.3.4 Monitoring of insectocutor shall be done twice a day and record shall be maintain accordingly.
6.3.5 Cleaning of insectocutors shall be done daily.
6.3.6 The numbers of insect and their type (accordingly decide the insecticide or fliocides) shall be count daily and their record shall maintain.
6.3.7 Insectocutor tray shall clean on daily basis and the killed insect shall bury and record shall maintain accordingly as per Annexure-IV.
6.4 Safety Precautions
6.4.1 The Insecticides / Pesticides used are highly toxic and so avoid contact with skin and eyes.
6.4.2 Inhalation should be avoided during spraying.
6.4.3 Oral ingestion to be avoided.
6.4.4 In case of poisoning, call the physician immediately.
7.0 Forms and Records (Annexures)
Pest control record – Annexure-I
Rodent box inspection record – Annexure-II
Chemicals to be used for pest & rodent control – Annexure-III
Insectocutor log record – Annexure-IV
List of insectocutors – Annexure-V
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Stores, Quality Control, Engineering and Human Resources.
|Date||Revision Number||Reason for Revision|
Date: ___________ Month: _______ Week: __________
Pesticide Used: _________________________ Frequency: weekly
(Sign and Date)
(Sign & Date)
|Manufacturing||Outer passage and Entry point||
|Engineering||All the corners, passages, entry points, around the machines and tanks.|
|Admin. (QA/P&A)||Entry points|
|F.G. Store||Entry Point|
|Security||All the passages, corridors ,entry , exit points|
|Plant||All the corners and the periphery of security, admin. Production and Engg. Block.|
Note: Pesticide must be rotate from week to week.
|S. No.||Brand Name||Composition||Usage|
|1||Viper Plus||Alphacypermethrin||To kill wide range of house fly.|
|2||Alpha Guard||Cypermethrin||To kill wide broad spectrum insects|
|3||Gokilaht||Cyphanothrin||To kill wide broad spectrum insects|
|4||K-othrin||Deltamethrin||To kill wide broad spectrum insects|
|5||Glue Pad||Gum||To trap the rodent|
Frequency: Twice a day Month:
|Date||Time||Nos. of Insects found||Type of Insects||Cleaning
|Disposal of insects Done by||Cleaning & Disposal
|Main Entrance Gallery|
|Main Entrance Gallery|
|Near Lift (in Front of P.M Store)|
|Liquid Finish Good Out Way|