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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 1 of 8
2. SCOPE
This work instruction describes the execution of routine microbiological analysis
and physical analysis of caps.
3. GLOSSARY
mL = Milliliter
cm = Centimeter
WI = Work Instructions
C = Degree Centigrade
CFU = Colony Forming Unit
COA = Certificate of Analysis
GPT = Growth Promotion Test
4. RESPONSIBILITIES
4.1 ANALYST:
To interface this work instruction to the actual practices of flow patterns.
To ensure that the work instruction is updated & reflects the actual execution.
To review the work instruction in case of any change or whenever it is due for
revision.
4.2 Microbiologist:
- To interface this work instruction to the actual practices of flow patterns.
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 2 of 8
4.3 A. M. Microbiology:
- To follow the instructions lay down by this work instruction.
- To keep the relevant work instructions valid and updated.
as defined.
5. PROCEDURE:
6. HEIGHT: Measure the height in mm of 03 units and note the average height
in the report Register QC/RG-012
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 3 of 8
9. WEIGHT: Check the weight of 03 units, measure the average weight and note it
in the Report Register QC/RG-012
10. THREADING: Check the threading of 10 units individually, the threading of all 10
caps should be OK to well fit on the bottle.
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 4 of 8
Dip aseptically 10-20 cap pads into the Sterile Peptone Solution / Sterile Tryptic Soy
Broth. Shake well, further dilutions, where necessary, are prepared with the same diluent.
Liquefied Tryptic Soya Agar to each plate. Cover the dishes, mix the sample
with agar by tilting or rotating the dishes, and the contents to solidify at room
temperature. Invert the petri-dishes and incubate these two plates at 30 - 35 C
13.3 TOTAL COMBINED YEAST/ MOULD COUNT (TYMC): Pipette 1 mL of the prepared
sample into each of two sterile petri-dishes. Add 15 - 20 mL cooled Sterile Liquefied
Sabouraud Dextrose Agar to each plate. Cover the dishes, mix the sample with agar by
tilting or rotating the dishes, and the contents to solidify at room temperature.
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 5 of 8
CALCULATION: Record the number of colonies per plate and calculate the result by
multiplying by a dilution factor of 10 to give results in CFU/100 cm2.
13.5 TEST FOR ESCHERICHIA COLI: Shake the bottle, transfer 1 mL of Tryptic Soy
Broth to 100 mL of MacKonkey Broth and incubate at 42 44 C for 24 hours.
After completion of 24 hours incubation, shake the bottle and transfer 1 mL from
MacConkey Broth to MacConkey Agar plates, incubate at 30 35 C for 24 hours.
If colonies grow on MacKonkey Agar plates these indicate the possible presence of
Escherichia coli. This is confirmed by identification tests and also subculture on
Eosine Methylene Blue Agar medium.
The product complies with the test if no colonies are present OR if the identification
tests are negative.
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 6 of 8
When an acceptance criterion for microbiological quality for Yeast and Mold of product
is prescribed, it is interpreted as follows:
10 CFU = Maximum Acceptable Count = 20;
102 CFU = Maximum Acceptable Count = 200;
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 7 of 8
14. TRAINING
Training of the concerned work instruction shall be given to the personnel who will be
exercising the work instruction. And training record is to be maintained
15. APPENDICES
Log Register No. QC/RG-48
Form No. FZ-164
Folder No. QC/FR-81 (Packing Materials)
16. REFERENCE
United States Pharmacopoeia USP 35, NF 30.
British Pharmacopoeia 2012.
Center for Drug Evaluation and Research (CDER 1999).
WHO Guidelines 2012
17. DISTRIBUTION
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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Work Instructions
WI No. fQ-509
Effective Date October 1, 2015
Review Date: October 1, 2018
Page No: 8 of 8
Distribution Retrieval
18. HISTORY
Date Reason of Change
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
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