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Microbiologist Validation Protocol Protocol No: DNIL - AV.P.021.00 Page 1 of 7

This document outlines a validation protocol for microbiologists at Daily-Need Industries Limited. The objectives are to establish that microbiologists are properly trained and their work is reproducible by analyzing samples of known values. Responsibilities include the quality control coordinator preparing the protocol and identifying samples, a reference microbiologist performing tests, and the microbiologist being validated. Tests include microbial assays, media preparation, and equipment operation. Acceptance criteria require validated microbiologists' results to be within ±10 of the reference values. The conclusion will validate the microbiologist if acceptance criteria are met.

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345 views

Microbiologist Validation Protocol Protocol No: DNIL - AV.P.021.00 Page 1 of 7

This document outlines a validation protocol for microbiologists at Daily-Need Industries Limited. The objectives are to establish that microbiologists are properly trained and their work is reproducible by analyzing samples of known values. Responsibilities include the quality control coordinator preparing the protocol and identifying samples, a reference microbiologist performing tests, and the microbiologist being validated. Tests include microbial assays, media preparation, and equipment operation. Acceptance criteria require validated microbiologists' results to be within ±10 of the reference values. The conclusion will validate the microbiologist if acceptance criteria are met.

Uploaded by

HBN
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 1 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

VALIDATION NUMBER :
 

ANALYST NAME :
 

QUALITY DEPARTMENT : Quality Control.


 

SUPERVISED BY(Name /Signature) :

START DATE :
 

END DATE :

 
MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 2 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

1.0. OBJECTIVE:
The objective of this Validation is to establish documented evidence that Microbiologists
of Daily-Need Industries Limited working in the Microbiology Laboratories have the
requisite training and experience to work on Equipment and Processes under the
required testing conditions, and their work is reproducible.

2.0. SCOPE:
The scope of this Validation is to show that Microbiologists are Validated based on
Compendia methods, In-house methods, equipment use, Processes, and other necessary
activities that have the potential to affect analytical results which could lead to Product
Quality Impact.

3.0. RESPONSIBILITIES:
3.1. Quality Control Coordinator: Preparation of Analyst Validation Protocol, identifies
sample for analysis, gives instruction on type of analysis to be done
3.2. Reference microbiologist: Performs reference of the test(s) used in the validation.
3.3. Microbiologist: Performs validation exercise as stated in Standard Testing
Procedure.
3.4. Head of Quality Operations: Approval of Validation Report.

4.0. METHOD OF VALIDATION OF CHEMICAL ANALYST/MICROBIOLOGIST.


4.1. Samples of known analytical values/microbial contamination shall be identified by
the Quality Control coordinator.
4.2. The analytical values/contamination of samples along with acceptable limit(s),
Analytical Report Number, and Code No. shall be recorded by Quality Control
coordinator in a register maintained for this purpose.
4.3. All the coded samples shall be kept sealed and stored as per required storage
conditions.
4.4. The coded samples along with necessary information required for analysis shall be
given to the microbiologist.
4.5. Only materials already approved by Quality Control Laboratory shall be used as
testing material for routine validation exercise.
4.6. The analyst shall be validated for following areas of analysis.
4.6.1. Microbial Assay as per STP (QCMGF002).
4.6.2. Preparation of Various culture media and handing/operation of
Microbiology laboratory equipment as per STP (QCMGF010).
MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 3 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

5.0. EQUIPMENT AND MATERIALS


5.1. The following equipment and materials would be used to carry out this validation.

S/N EQUIPMENT/MATERIALS REFERENCE ID


MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 4 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

6.0. REFERENCES
SN SOP NO. (Current version). TITTLE OF SOP
WHO Technical Report Series, No. 961, 2011 WHO good practices for
01.
Annex 2 pharmaceutical
microbiology laboratories
WHO Technical Report Series, No. 957, 2010 WHO good practices for
02.
Annex 1 pharmaceutical
quality control laboratories
QCGF021 Procedure for analyst
03.
Validation.
QCGF002 Procedure for Microbial
04
Limit Tests.
QCGF010 Procedure for sampling of
04.
raw Materials
QCMPF013 Procedure for Media
05.
preparation.
BP 2015 Vol. V Appendix XVIB Pg.V-A525
06.
Procedure4-2, 4-3, 4-4 Pg.V-
A525-526 Procedure4-5,
Pg.V-A529 Procedure4-5-1,
Pg.V-A531 Procedure5-2-2-
1.

7.0. ANALYTS VALIDATION INFORMATION

ANALYST NAME POSITION STAFF QUALIFICATIONS EXPERIENCE DETAILS OF ANALYSIS TRAINING


NO (YRS) DONE
YES/NO

.
MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 5 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

8.0. EVALUATION

Sr. Test Acceptance ANALYST NAME(S) STP METHOD NO.


No Criteria
1 MLT/TYMC/TAMC Difference 1.Reference
should not Microbiologist
differ by more
than ±10 from
initial/original
value/reference 2.
microbiologist.
2 Sterility/Sensitivity 1.Reference
Microbiologist

2.

Note: MLT – Microbial limit test; TYMC – Total yeast & mould count; TAMC - Total aerobic microbial count.

9.0. TESTING AND ACCEPTANCE CRITERIA

Sr. No. Test Acceptance Criteria


1 Total Aerobic Difference should not differ by more than ±10 counts from
Microbial Count initial/original value/reference microbiologist.
2 Total Yeast and Mould Difference should not differ by more than ±10 counts from
Count initial/original value/reference microbiologist.
3 Test for Pathogen Accurate Determination
MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 6 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

10.0. REPORT SUMMARY

ANALYST NAME METHODS OF RESULT AS PER DIFF SUPERVISED


ANALYSIS ACCEPTANCE CRITERIA (NMT BY
(STATE ATTACHMENT) 10) NAME/DATE
/SIGN

Ref Microbiologist.
TYMC

Ref Microbiologist.
TAMC

PATHOGENS/
Ref Microbiologist.
SENSITIVITY.

11.0. DEVIATION

DEVIATIONS :
MICROBIOLOGIST VALIDATION PROTOCOL

PROTOCOL NO: Page 7 of 7


DAILY-NEED INDUSTRIES LTD DNIL.AV.P.021.00

12.0. CONCLUSIONS

Signatures in this page indicate that this document has been prepared, checked and approved by
the concerned personnel. It shall be signed and dated as shown below.
DESIGNATION NAME SIGNATURE DATE
PREPARED BY: Barisua H Nwikpasi.

REVIEWED BY: Adedoyin Tinubu.

APPROVED BY : Ngozi Osuji.

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