MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

Objective:

The objective of this document is to perform a risk assessment of Microbiological Quality Control Operations in Abhilash
life sciences LLP and to understand the risks, if any and to initiate a time bound action plan to mitigate the identified risks.
Purpose:

This assessment is intended to identify the risks involved in the Microbiological Quality Control Operations in Abhilash life
sciences LLP and to plan the mitigation measures for identified risks.
Scope:

The evaluation is applicable to all the Microbiological Quality Control Operations in Abhilash life sciences LLP. Some of the
key steps/processes that are covered in this evaluation are detailed below.
 Entry and Exit Procedure.
 Transportation of the samples to the lab.
 Sample receipt & registration.
 Storage of samples.
 Verification of cleaning, temperature, RH & differential pressures.
 Sterilization of accessories & media.
 Transfer of samples & accessories through the pass box.
 Handling of the Media and accidental spillages.
 Handling of Analysis.
 Monitoring of the Test Areas.
 Incubation conditions.
 Human Risk & Intrusion factors.
 Training and Qualification of Microbiologists.

All the above key steps involved in the Microbiological analysis shall be individually mapped to understand the risks
associated with the process and evaluated against the existing controls. Based on the RPN score, the risks identified shall
be preference and an action plan shall be drawn for mitigation of the identified risks.

Background:

The Microbiology lab is designed to cater to the microbiological analysis of Oral Solid Dosage Forms. The test facility is
designed to meet the ISO 7 and the supporting areas to meet the ISO 8 classification. The Microbiology lab is provided
with adequate air locks to prevent the ingress of the particulate contamination into the lab. The main lab is provided with
an air lock before entry. The personnel wearing the clean factory garments & foot wear and enter the air lock of the
microbiology lab, remove the footwear and keep at designated place; crossover bench and wear the head cap,
Laboratory apron then laboratory foot wear. After performing the hand disinfection they finally enter in to the
laboratory.

The microbiology lab is designed with segregated areas for specified activities. A separate documentation area is
provided for handling and keeping the working documents in properly labeled specified areas. The separate rooms
include Lab office, Store room, Media preparation room, Sterilization area, cool zone area, MLT testing area, Culture
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

handling area, incubation room, buffer room, wash area and decontamination area. Lab is provided with a adequate pass
box to transfer the sample. Decontamination of the used media waste and cultures is being taken care in a separate area.

The test facility is provided further with change room for Testing area and for cool zone area, Testing area separated as
MLT testing area and Culture handling area respectively. Trained and qualified microbiologists are authorized to enter the
test areas. The microbiologists wear the garments as per the gowning before entering in to the test areas.

The tests for Microbial Enumeration for non-sterile products, water analysis, other miscellaneous activity, Plate
preparation and culture preparation and are being performed in the segregated test facilities. Exposure of agar plates is
being done in the test areas for monitoring the manufacturing and test areas as well.

Media preparation and usage is handled as per the written procedures and well controlled from receipt to usage for
analysis, till its disposal in a safe mode.

Reference cultures are procured from the ATCC and used as per the written procedures and controlled. Cultures used for
analyses are within 5 passages from the original culture. All the necessary controls are in place to assure the proper usage
and to assure the safety of handling the cultures to the operators and the environment.

As part of this evaluation, key processes/steps shall be reviewed, assessed in a brain-storm session among the
microbiology team and various risks shall be identified. Each of the risk shall be assessed and quantified. Based on the
score, an action plan shall be initiated to mitigate the identified risks on priority basis.
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

Occurrence / Probability (O)

New RPN

Potential Risk Priority

Potential Potential Responsibil

Detection (D)
Severity (S)
Failure Number
S. Item / Effect of cause(x) Recommended ity & Target
Mode Current Control (RPN) RPN
No Function Failure mechanism of Action (x) Completion
(Failure S O D
(Effect) Failure Date (S*O*D)
Mode) (S*O*D)

1. Personnel Entry with Contamin Non-adherence By design, the lab is No addition/

Entry into the unclean ation to the provided with an air lock mitigation
Microbiology garments& procedure& before entry in to lab. measures are
Lab maintenance of The instructions are in recommended.
unhygienic
personnel place for foot wear
conditions hygiene. change and disinfection at
the air lock.
The air lock leads in to the
ISO class-8 Corridor with a
view panel to see the
entry of any unauthorized
personnel in to the air
lock.

The staffs are

microbiologists by
qualification, trained on
the best microbiology
practices and qualified.
Entry of other personnel
is restricted to the lab and
if necessary they are
accompanied in to lab.
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

Occurrence / Probability (O)

New RPN

Potenti
Risk Responsibi

Detection (D)
Potential al Potential

Severity (S)
Priority lity &
S. Item / Failure Mode Effect cause(x) Recommended
Current Control Number Target
No Function (Failure of mechanism of Action (x) RPN
(RPN) Completio S O D
Mode) Failure Failure (S*O*D)
(S*O*D) n Date
(Effect)

2. Transportatio Contamination Contam Improper 1.) By procedure, the No addition/

n of the of the samples ination containment & samples are being mitigation
samples to during handling of the collected aseptically in a measures are
the lab samples. sterile polybag which is
transport & recommended
completely and firmly
transit. sealable. These poly bags
are placed inside a second
poly bag and sealed firmly
and transported to the
lab.
2.) By procedure, the
water samples are being
collected aseptically in
sterile srewcap bottle by
trained Microbiologist.
Occurrence / Probability (O)

New RPN
Potenti

Detection (D)
al Potential Risk Priority Responsibil
Severity (S)

Potential
S. Item / Effect cause(x) Number Recommended ity & Target
Failure Mode Current Control
No Function of mechanism of (RPN) Action (x) Completion RPN
(Failure Mode) S O D
Failure Failure (S*O*D) Date (S*O*D)
(Effect)

3. Sample Traceability of No Not allotting a The procedure is in place. No

receipt & the samples traceab unique number Each sample received in addition/mitigati
registration ility of for analytical the lab is allotted with a on measures are
the reference and unique number and
recommended
sample traceability entered into the inward
s register .The sample is
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

traceable with this

number.
All the interrelated
activities related to the
analysis of the particular
sample are traceable with
this unique AR No.

(O)Occurrence / Probability
New RPN
Potential Risk

Detection (D)
Potential Potential Responsibilit
Failure Severity (S) Priority
S. Item / Effect of cause(x) Recommended y & Target RPN
Mode Current Control Number
No Function Failure mechanism of Action (x) Completion (S*O*D)
(Failure (RPN) S O D
(Effect) Failure Date
Mode) (S*O*D)

4. Storage of Imprope Contamin Not keeping the The samples are stored as No addition/
Samples r storage ation of samples in per the product specific mitigation
conditio the specified recommendations in measures are
samples specified areas.
ns conditions. recommended
Visual checks are being
performed by the analyst
before taking them for
analysis. In case of any
discrepancy, the same is
brought to the notice of
the Section incharge for
necessary action further
follow up as per the SOP.
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

(O)Occurrence / Probability
New RPN
Potential Risk

Detection (D)
Potential Potential Responsibility

Severity (S)
Failure Priority
S. Item / Effect of cause(x) Recommended & Target
Mode Current Control Number RPN
No Function Failure mechanism of Action (x) Completion S O D (S*O*
(Failure (RPN)
(Effect) Failure Date
Mode) (S*O*D) D)

5. Verification Cross Contamin Improper The practices are in place for No

of cleaning, Contami ation maintenance of cleaning the laboratory daily addition/mitigati
temperature nation of area cleanliness using validated disinfectant on measures are
temperature, solutions.
, RH & the area recommended
RH,& differential
differential and pressures The appropriate procedures
pressures samples are in place for the recording
of temperatures, RH&
differential pressures in all
the critical areas twice daily.

6. Sterilization improper Contamin Improper The procedures are in place No

of sterilizati ation distribution of for sterilization of accessories addition/mitigati
accessories on temperature & & media as per the validated on measures are
load patterns. Storage
&media storage temperature hold recommended
conditions are maintained
conditio time conditions of for the media as per the
ns the autoclave. current procedure.
Improper packing
&storage
conditions.
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

(O)Occurrence / Probability
New RPN

Potential Risk

Detection (D)
Severity (S)
Potential Potential Responsibility
Failure Priority
S. Item / Effect of cause(x) Recommended & Target
Mode Current Control Number
No Function Failure mechanism of Action (x) Completion RPN
(Failure (RPN) S O D
(Effect) Failure Date (S*O*D)
Mode) (S*O*D)

7. Transfer of Contami Contamin Transfer of Procedure is in place for No

samples nation of ation samples the transfer of samples & addition/mitigatio
&accessories the &accessories accessories through the n measures are
through pass directly without dynamic pass box to
samples recommended
box. external minimize contamination
& sanitization to the possible extent.
accessori into the critical
es during areas
transit and other critical
mechanical
failures in
dynamic
operational
conditions of the
pass box.

8. Handling of Spillage Contamin Accidental spills The procedure is in place No

the Media ation to handle the spillage of addition/mitigatio
and the media accidentally. n measures are
accidental The microbiologists are
recommended
spills trained on the procedure.
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

(O)Occurrence / Probability
New RPN
Potential Risk

Detection (D)
Potential Potential Responsibility

Severity (S)
Failure Priority
S. Item / Effect of cause(x) Recommended & Target
Mode Current Control Number RPN
No Function Failure mechanism of Action (x) Completion S O D
(Failure (RPN) (S*O*D)
(Effect) Failure Date
Mode) (S*O*D)

9. Handling of Unqualified contami Improper The entry is restricted No addition/

Analysis personnel nation training of in to the testing area. mitigation
& improper analyst only to the authorized measures are
personnel.
handling. recommended
The samples are
handled by the
microbiologists who are
well trained on the best
practices.

10 Monitoring Non- contami Unable to The procedures are in No

. of the Test adherence nation contain, control place for the microbial addition/mitiga
to the & trace the monitoring of critical tion measures
Areas contamination areas by passive &
monitoring are
of the area. active air sampling.
frequency recommended
as per
schedule

11 Incubation Improper Keeping the Analyzed sample s are Process

. conditions maintence nutrients analysed stored as per specified checking &
of samples outside condition. systems are
Alarm system is in place
incubation the specified available &
for the identification of
conditions the incubation temperature shoot same systems to
conditions. conditions. be continued
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

Daily monitoring of
temperature is in place.

Probability (O)Occurrence /
New RPN
Risk
Potential

Detection (D)
Potential Potential Priority Responsibility
Severity (S)
Failure
S. Item / Effect of cause(x) Number Recommended & Target
Mode Current Control RPN
No Function Failure mechanism of (RPN) Action (x) Completion
(Failure S O D
(Effect) Failure Date (S*O*D)
Mode)
(S*O*D)

Practices of CGLP are in No

Un Improper
Human Risk & place &all addition/mitiga
hygienic contami hygienic
12 Intrusion microbiologist are well tion measures
conditio nation conditions &cross
factors trained on the best are
ns contamination
practices recommended

Imprope It may Improper Training &personnel No

Training and
r, lead to handling & cross qualification schedule is addition/mitiga
Qualification contamination by
training incorrect in place &only trained, tion measures
of assimilati analysis
the
qualified personnel are are
13. Microbiologis microbiologist
on & & leads allowed to execute the recommended
ts executio to analysis.
n of contami
practices nation
 MICROBIOLOGY FACILITY RISK ASSESSMENT AND MITIGATION

S.No Risk Priority Status of actions Checked Verified by

Agreed Actions By
Number (RPN / User HOD
User Dept.
Over all risk)

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

Completed /Not Completed

All the above agreed actions completed /not completed.

Remarks if any:

Prepared by: Reviewed by: Approved by:

Sign /Date: Sign /Date: Sign /Date: