PHARMA SCHOLARS

MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 1 of 10

1.0. OBJECTIVE:
1.1. To lay down a procedure for the good laboratory practices in microbiology department.

2.0. SCOPE:
2.1. This procedure is applicable for the GLP at Microbiology Laboratory of the Quality control department
of …………………….

3.0. RESPONSIBILITY:
3.1. Sr. Officer/Officer–Quality Control

4.0. ACCOUNTABILITY:
4.1 Head of the department is accountable to ensure the compliance of SOP for all aspects.

5.0 DEFINITION:
Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of
non-clinical laboratory studies that are intended to support research or marketing permits for products
regulated by government agencies

6.0. PROCEDURE:
6.1. Media Preparation:

6.1.1 It is important to choose the correct media or component in making media based on the use of accepted
sources or reference for formulas.
As different media types may have different preparation requirement (e.g. heating , additives and pH
adjustments.), it is important to follow these instructions to ensure preparation of acceptable media
quality.

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 2 of 10

5.1.3. Purified water is most often used for media preparation ,but in certain cases the deionized or distilled
water may be appropriate.

5.1.4. Consistent preparation requires accurate weighing of dehydrated media for which calibrated balance is
required.

5.1.5. Use clean spatula or tools to prevent contamination foreign matter.

5.1.6. Care should be taken not to over heat the media as all culture media to a greater extent are heat sensitive.

5.1.7. There should be adequate mixing , heating and sterilization of media.

5.1.8. Glassware’s should be clean. Be sure that the cleaning process removes debris and foreign matter, and
that the detergent is thoroughly rinsed out with purified water.

5.1.9. Sterilization of the media should be performed with in the parameters provided by the manufacturers or
by a validated process

6.2 Ideally provide the sterility assurance level (SAL) of the media against a recognized indicator.

6.2.1 The effects of sterilization method and conditions on media should be validated by sterility and growth
promotion testing of the media.

6.2.2 The autoclave cycle should be validated to ensure proper heat distribution for selected loads and volumes.

6.2.3 The pH of media each should be conformed after it has cooled to room temperature by aseptically
withdrawing a sample for testing.

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 3 of 10

6.2.4 Prepared media should be checked by appropriate inspection of plates and tubes for:
a) Cracked containers or lids.
b) Unequal filling of containers.
c) Hemolysis.
d) Dehydration resulting in cracks.
e) Excessive darkening or color change.
f) Excessive number of bubbles.
g) Microbial contamination.
h) Lot number and expiry date checked and recorded.

6.3 Media storage:

6.3.1 Media should be labeled properly with batch or lot numbers, manufacturing and expiry dates, media
identification and should be stored according to the manufacturer’s instruction.

6.3.2 Do not store agar at or below 0°C, as freezing could damage the gel structure.

6.3.3 Remelting of original containers of solid media should be performed only once.

6.3.4 Disposal of used cultured media should follow local biological hazard safety procedures.

6.4. Quality control testing of media:

6.4.1 Quality control tests should be performed on all prepared media .Test routinely performed are pH, growth
promotion test.

6.4.2 When a batch of media does not meet the requirements of growth promotion test , an investigation should

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Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 4 of 10

be initiated to identify the cause. This investigation should include a corrective action plan to prevent the
recurrence of the problem.

6.4.3 Media used for environmental monitoring studies should be wrapped double and terminally sterilized. If
terminal sterilization is not performed, media should be subjected to preincubation and 100% inspection
prior to use with in a critical area.

6.5 Maintenance and handling of microbiological cultures:

6.5.1 Cultures used in compendial tests should be acquired from a national culture collection centers.

6.5.2 Cultures can be acquired frozen, freeze-dried, on slant or in ready to use forms.

6.5.3 Preparation of culture should follow the instructions of supplier.

6.5.4 The “seed lot” technique is recommended for storage of stock cultures.

6.5.5 The number of transfers of working control cultures should be tracked to prevent excessive sub culturing
that increases the risk of phenotypic alteration.

6.5.6 Following precautions shall be strictly observed while handling microbial cultures in the microbiology
testing area:

The access to the Microbiology Testing Area as well as places where live microorganisms are stored
shall be restricted to authorized persons only. Only qualified and trained microbiologists will have an
access to these organisms.

6.5.7 All microbial cultures shall be stored in a safe dedicated place.

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 5 of 10

6.5.8 The surface of the working bench where microbial cultures are handled shall be impervious to water and
resistant to acids, alkalis, solvents and the disinfectants.

6.5.9. Personnel protective like hand gloves and facemask shall be put on before handling live cultures.

6.5.10 All the microbiological procedures shall be performed in such a way that no aerosols are generated.

6.5.11 Effective disinfectant shall be available for immediate use in the event of any spillage.

6.5.12 In the event of an accidental spillage of microbial culture refer the SOP no. SOP/QM/023

6.5.13 Mouth pipetting shall be forbidden.

6.5.14 Hands shall be decontaminated immediately when contamination is suspected.

6.5.15 As a safety precaution the protective clothing put on, during handling of live cultures shall be carefully
placed in disposable bag and shall be de-contaminated in an autoclave at 121° C for 30 minutes in
microbiology laboratory itself before their washing and re-use.

6.5.16 Glassware and accessories used while handling live cultures shall be similarly segregated and de-
contaminated in an autoclave before washing and reuse.

6.6 Maintenance of laboratory equipments.:

6.6.1 Equipments like incubators, water baths, autoclave should be subjected to incoming qualification ,
operational qualification and performance qualification.

6.6.2 The frequency of calibration and performance verification will vary based on the type of instrument and

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 6 of 10

the importance of that equipment to the generation of data in the laboratory.

6.7 Laboratory layout and operation:

6.7.1 Microbiology laboratory layout should be such that the cross-contamination of microbial contamination
be minimize to the greatest extent possible.

6.7.2 Laboratory should be divided into clean or aseptic area and live culture area.

6.7.3 Area in which environmental or sterile product samples are handled , should be maintained completely
free of microbial contamination.

6.7.4 There should be proper clothing , sanitization and disinfection procedure and LAF designed for clean and
aseptic operation only.

6.7.6 Sub-culturing ,staining, microbial identification or other investigational operations should be undertaken
in live culture section of the laboratory.

6.7.6 Staff engaged in sampling activities should not enter or work in the live culture handling section of the
laboratory unless special precautions are taken , including wearing protective clothing and gloves, and
careful sanitization of hands upon exiting.

6.7.7 Environmental sampling require minimal aseptic handling in loading and unloading sampling instrument.

6.8 Training of personnel:

6.8.1 Each person engaged in all phases of pharmaceutical manufacture should have the education , training
and experience to do their job.

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 7 of 10

6.8.2. Training should be establish for each laboratory staff members .They should not independently conduct a
microbial test until they are qualified to run the test.

6.8.3 Microbiologist with supervisory or managerial responsibilities should have appropriate education and in-
house training in supervisory skills, laboratory safety, laboratory investigation technical report writing ,
relevant SOPs and other critical aspects related to laboratory.

6.9 Documentation:
Documentation should be sufficient to demonstrate that the testing was performed in a laboratory by the
method that were under control. This includes the documentation as follows:
a) Microbiologist training .
b) Equipment validation, calibration and maintenance.
c) Equipment performance during the test.
d) Media preparation, sterility checks and growth promotion tests.
e) Data and calculation verified .
g) Report verified by QA .
h) Investigation of data deviation.

6.10 Maintenance of laboratory records:

6.10.1 The laboratory write up should include:

a) Date
b) Material tested
c) Microbiologist’s name

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 8 of 10

e) Procedure name
f) Document test results
g) Deviation ( if any)
h) Documented parameters (equipment used, microbial stock cultures used, media lots used)
i) Management/Second review signature.

6.10.2 Every critical piece of equipment should be noted in write-up and all should be on a calibration schedule
documented by SOP and maintenance record. Where appropriate log book or forms should be available
and supportive of the laboratory note book to record the equipment temperature.

6.10.3 The governing SOP and revision should be clearly noted in the write-up.

6.10.4 Original data should not be erased or covered over.

6.10.5 All Laboratory record should be archived and protected against catastrophic lose. A formal
record retention and retrieval programme should be in place.

7.0. ABBREVIATION:
Abbreviation used Full form of abbreviation used
QC Quality Control
QA Quality Assurance
SOP Standard Operating Procedure
LAF Laminar Air Flow

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Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 9 of 10

IPA Isopropyl Alcohol

Asst Assistant
Ltd. Limited
AVP Assistant Vice President
AGM Assistant General Manager
°C Degree Celsius
Glp Good Laboratory Practices

8.0. ANNEXUREURE:
NA

9.0 DISTRIBUTION:
• Controlled Copy No. 01 Quality Assurance
• Controlled Copy No. 02 Quality Control
• Master Copy Quality Assurance Department

10.0 REFERENCES:
➢ IH

11.0 REVISION HISTORY:

Revision No. Change Control Details of Reason of Effective Done By

No. Changes Changes Date
00 Not Applicable Not Applicable New SOP

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..

 PHARMA SCHOLARS
MICROBIOLOGY DEPARTMENT

STANDARD OPERATING PROCEDURE

Restricted Circulation
Department: Quality Control (Microbiology)
TITLE: MICROBIOLOGICAL GOOD LABORATORY PRACTICES
SOP No. Revision No.
Effective Date Supersedes No.
Review Date Page No. 10 of 10

--- Prepared By Checked By Approved By

Officer/Executive Department Head Head Quality Assurance
Name

Signature

Date

FORMAT No.: ………………………..