Академический Документы
Профессиональный Документы
Культура Документы
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
1 of 8
Title
A.M. Microbiology
Manager Quality Control
Manager Quality Assurance
Director Quality Operations
Signature
Date
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
= Degree Centigrade
CFU
COA
= Certificate of Analysis
GPT
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:
-
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
2 of 8
4.3
4.4
To ensure that the work instruction is updated & reflects the actual
execution.
A. M. Microbiology:
-
4.5
5.
PROCEDURE:
6.
HEIGHT: Measure the height in mm of 03 units and note the average height
in the report Register QC/RG-012
7.
8.
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
3 of 8
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.
11. CLEANLINESS CHECK: Check the cleanliness of 10 units. The test
passes if the caps are not dirty or do not contain any foreign particles in it.
12. MICROBIOLOGICAL ANALYSIS:
12.1
REQUIREMENTS
12.1.1
Oven
12.1.2
Incubator
12.1.3
Autoclave
12.1.4
Peptone Water
12.1.5
Cetrimide Agar
12.1.6
12.1.7
12.1.8
MacConkey Agar
12.1.9
MacConkey Broth
12.1.10
12.1.11
12.1.12
12.1.13
12.1.14
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
4 of 8
12.1.16
12.1.17
12.1.18
12.1.19
13.
13.1
13.2
13.3
As per COA.
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
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.
13.4
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.
13.6
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
6 of 8
13.7
13.8
INTERPRETATION OF RESULTS:
FOR TOTAL AEROBIC MICROBIAL COUNT (TAMC):
If the fungi are detected / observed on Tryptic Soy Agar plates, they are counted as
part of TAMC.
When an acceptance criterion for microbiological quality for Bacteria of product is
prescribed, it is interpreted as follows:
13.9
10 CFU
20;
10 CFU
200;
103 CFU
20;
102 CFU
200;
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
7 of 8
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
Sign:
Date
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.
COPY NO.
fQ-509
October 1, 2015
October 1, 2018
8 of 8
18.
Signature
Date
Retrieval
Copy No.
Signature
Date
HISTORY
Date
April 3, 2015
Reason of Change
New version
Sign:
Date
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.
COPY NO.