MPK | SOP FOR GENERAL FUNCTION OF MICROBIOLOGICAL LAB IN PHARMACEUTICAL INDUSTRY

 

SOP FOR GENERAL FUNCTION OF MICROBIOLOGICAL LAB IN PHARMACEUTICAL INDUSTRY

MICROBIOLOGICAL LAB

1.0.      Purpose

This SOP is required to get a general concept about the functions performed in Microbiology lab.

2.0.      Scope

This procedure is applicable to the Microbiology Lab of (Pvt.) Limited.

 3.0.      Responsibilities

Action	Responsibility
To follow this procedure	Microbiologist
To implement this procedure	Incharge Microbiology Lab

 4.0.      Procedure

Following are the main functions that perform in Microbiology lab to get the general concept of Microbiology lab.

 4.1. Depyrogenation

S. No	Action	Responsibility
4.1.1	All the glassware used in Micro lab should be sterilized/dehydrogenated in oven per its SOP. Depyrogenation record is maintained.	Microbiologist

 4.2. Discarding of tested media and Pure cultures:

S. No	Action	Responsibility
4.2.1	Discard the used media and pure cultures by autoclave and use of disinfectant as per SOP.	Microbiologist

 4.3. Washing of glassware and other apparatus:

S. No	Action	Responsibility
4.3.1	Washing of glassware's and apparatus is performed after discarding of media and samples with detergent and finally ruins with distilled water.	Microbiologist

 4.4. Refrigeration:

 

S. No	Action	Responsibility
4.4.1	Place prepared and autoclaved media at below 8°c in refrigerator. Test samples are also kept in the refrigerator. All pure cultures are also maintained and store below 8°c.CSE is kept in refrigerator after reconstitution.	Microbiologist
4.4.2	All Lysate tubes after reconstitution are kept at freezer i.e below - 4°c or below. Daily monitoring of both refrigerators QC-090 and -089 is performed on daily basis.

 4.5. Weighing and pH monitoring:

 

S. No	Action	Responsibility
4.5.1	Physical Balance is used to weight the media, testing samples and other chemicals. Balance is calibrated daily prior use. It is also calibrated on monthly basis.Quaterly calibration is performed by the outside source (Scalemans) Records are maintained in respective log files.	Microbiologist
4.5.2	pH monitoring is performed of media prepared and autoclaved. Buffers are prepared by monitoring their pH through pH meter. pH meter is calibrated prior use by standards of pH 7.0 and 4.0.Record is maintained in respective log files.

  4.6. Autoclavation:

 

S. No	Action	Responsibility
4.6.1	All media used in Micro lab is must be sterilized by Autoclave. All glassware and equipments that are highly heat sensitive are sterilized by Autoclave .The glassware or other items that are not required to be dry are also sterilized by Autoclave.	Microbiologist
4.6.2	Record of every Autoclave cycle is maintained with an indicator. Validation of Autoclave sterilization cycles is performed on annual basis. Operate the Autoclave as per SOP # QC

 4.7. Maintenance of Pure cultures:

 

S. No	Action	Responsibility
4.7.1	Pure cultures are maintained by subculturing into fresh slants at specified time and  kept in refrigerator below 8°c.These pure cultures are used as positive controls in Microbial contamination, in growth promoting test product suitability tests and Bioassays.	Microbiologist

 

 

4.7.2

List of Pure cultures and maintenance record of Pure cultures is documented and maintained.

Microbiologist

 

  4.8. Maintenance of Secondary standards:

 

S. No	Action	Responsibility
4.8.1	All secondary standards of antibiotics used in bioassay tests are kept in dessicator. They all are maintained in a list with C.A and expiry dates.	Microbiologist

 

  4.9. Cleaning and Maintenance of all equipments:

 

S. No	Action	Responsibility
4.9.1	Cleaning of all equipments is performed on daily basis or as per requirement. Maintenance is also check at specified intervals.	Microbiologist
4.9.2	Cleaning and maintenance is check through monitoring at specified intervals and monitoring record is maintained.

 

 4.10. Calibration of all equipments:

 

S. No	Action	Responsibility
4.10.1	Calibration of all micro lab equipments is performed by outside services company, Mecca Engineering and co.	Microbiologist

 

    4.11. Maintenance of Sterility suit for sterility test:

 

S. No	Action	Responsibility
4.11.1	Sterility suit is maintained by one HEPA inside connected with HVAC. Positive pressure is record by a magnahelic gauge. Temperature and humidity is also checked and record by a hygrometer placed outside the. room	Microbiologist
4.11.2	Cleaning record is also maintained of sterility suit. The areas is check by daily and weekly area monitoring and record the results in specified Performa.
4.11.3	Area of sterility suit is also validated on annual basis.

 

        4.12. Bioassays:

 

S. No	Action	Responsibility
4.12.1	These tests are performed to determine the potency of antibiotics through microorganisms. These tests are performed as per respective SOPs.	Microbiologist

 

        4.13. Microbial contamination tests:

 

S. No	Action	Responsibility
4.13.1	Microbial contamination tests are performed of all the oral products including tablets, syrups, suspensions, dry syrups and capsules.Microbail tests of all raw materials are also performed as per SOPs.	Microbiologist

 

 4.17. Area Monitoring of Non sterile and sterile areas:

 

S. No	Action	Responsibility
4.17.1	Area monitoring is performed in all sterile areas including Eye/Ear drops, Ampoule section and Cephalosporin area on daily basis and Monthly basis as per SOP. The results are delivered to all departments and allow production in these areas based on the results.	Microbiologist

 

  4.14. Pyrogen test:

 

S. No	Action	Responsibility
4.14.1	Animal house is maintained for Pyrogen testing. Healthy rabbits are used for Pyrogen test. Proper housing is arranged for Rabbits and cleaning is checked on daily basis. Their feeding record is also maintained and All rabbits are physically checked at specified time and record is maintained.	Microbiologist
4.9.2	Their injection history record is prepared with the tests.Pyogen test is performed and reported as per the SOP and record in the log book.

   4.15. Sterility test:

 

S. No	Action	Responsibility
4.15.1	This test is performed as per SOP of all Injectable manufactured All Injectables are tested for sterility inside the maintained sterility suit.	Microbiologist
4.9.2	All Injectables should pass this test and products released after 14 days of incubation. Daily monitoring of the test is performed and recorded in the specified log book.

 

 4.16. Endotoxin tests:

 

S. No	Action	Responsibility
4.16.1	To detect the presence of Endotoxin and its amount in all Injectables products Endotoxin test is perform by Gel Clot method.	Microbiologist
4.16.2	LAL reagents are used to perform the test as per SOP and record in the specified log books. The test is also perform for manufacturing water of Ampoules and Eye/Ear drops and released for manufacturing after passing the test. A separate record for manufacturing water i.e. W.F.I is also maintained.

  4.17. Area Monitoring of Non sterile and sterile areas:

 

S. No	Action	Responsibility
4.17.1	Area monitoring is performed in all sterile areas including Eye/Ear drops, Ampoule section and Cephalosporin area on daily basis and on Monthly basis as per SOP. The results are delivered to all departments and allow production in these areas based on the results.	Microbiologist
4.17.2	Area monitoring of all non sterile areas is performed as per SOP on fortnightly basis. The results are documented and communicated to concerned area Supervisors for advice and action.

 

 4.18. Water testing:

 

S. No	Action	Responsibility
4.18.1	Microbial quality of water used in production of sterile and nonsterile products is examined on daily basis. There is a weekly examination of all water supply is carried out as per SOP. The results are documented and action is taken as per the Alert and Action limits.	Microbiologist

  4.19. Reporting and Documentation:

 

S. No	Action	Responsibility
4.19.1	Reports of all testing is transfer to QA deptt. for release and approvals. All tests are performed as per the controlled SOPs and documents are checked and revised periodically.	Microbiologist