CONSERN PHARMA LIMITED, LUDHIANA

Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page

DEPARTMENT: QUALITY ASSURANCE 1 of 7
Risk Assessment Protocol
Protocol No. Department

INDEX
SR. TOPIC PAGE NO.
NO.

1.0 PRE-APPROVAL
2.0 INDEX
3.0 PURPOSE
4.0 RISK ASSESSMENT TEAM
5.0 BACKGROUND
6.0 RISK ASSESSMENT
7.0 ACTION TAKEN
8.0 SUMMARY & CONCLUSION

1.0 APPROVAL SIGNATURE

The protocol has been prepared, checked and approved by the under Signed:

Format No.: CP/QA/010-F01/18-02

 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 2 of 7
Risk Assessment Protocol
Protocol No. Department

DEPARTMENT NAME DESIGNATION SIGNATURE DATE

PREPARED
BY
Quality
Executive
Assurance

DEPARTMENT NAME DESIGNATION SIGNATURE DATE

Quality
Executive
Assurance
CHECKED
BY
Production Head

Quality Control Executive

DEPARTMENT NAME DESIGNATION SIGNATURE DATE

APPROVED Quality
Manager
BY Assurance

Operation Mg. Director

1.0 PURPOSE

Format No.: CP/QA/010-F01/18-02

 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 3 of 7
Risk Assessment Protocol
Protocol No. Department

2.0 RISK ASSESSMENT TEAM

Name Department Date Signature

3.0 BACKGROUND

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 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 4 of 7
Risk Assessment Protocol
Protocol No. Department

4.0 RISK ASSESSMENT

Sr. Operating Area,/ Potential Failure Potential Effect Potential Cause(s) Current Recommended

RPN = S x O x D
Detectability
No Activity/Stage Mode/ Hazard Control Measures Action(s)

Occurrence
Severity
.

Improper storage
condition of the
Product fails to meet Improper labeling of Storage condition System in
coated tablets may control
1 COATING standard 3 materials, Not follow 2 mentioned in both 2 12
have impact on the up of SOP
specification SOP & BPR
product quality

Inlet or outlet Tablet sticking,

Improper working Coating process stop
temperature may product fails to meet System in
2 COATING standard specification 5 of Hygrometer 3 along with the spray 2 30
be outside from the control
rate.
set value
Cleanliness of the
area and equipment
Contamination can
COATING Cross Not following is verified by both
occur from the left System in
3 Contamination and 5 relevant SOP and 3 production and 3 45
over residue of the control
Material loss Storage condition. IPQA personnel
previous product
before coating
process

Format No.: CP/QA/010-F01/18-02

 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 5 of 7
Risk Assessment Protocol
Protocol No. Department

Temperature, relative All the condition to be

Sticking of tablet
humidity and Not follow relevant verified from BPR and System in
4 COATING differential pressure due to higher 4
SOP
5
SOP before starting
3 60
control
may go out of limit moisture content the process

Improper mixing,
uneven spray Go for geometric
Alteration of the
pattern, insufficient mixing, reformulation
frequency and
coating migration of with different System in
5 COATING Colour Variation duration of appearance 4 5 2 40
soluble dyes- plasticizers and control
of tablets in the spray
plasticizers and other additives or use mild
zone
additives during drying conditions.
drying
Each and every
Compressed tablet of container is verified
Improper labeling of
6 COATING other batch/products with the label and System in
Cross Contamination 5 materials, Not follow 4 2 40
can be taken for with the BPR before control
up of SOP
coating taking into coating
process

Inability of foam, Bubble or foam

Add alcohol or use
formed by air spraying formation because of System in
7 COATING Infilling
of a polymer solution,
4
air spraying of a
4 spray nozzle capable 3 48
control
of finer atomization.
to break. polymer solution

Entrapment of gases
in or underneath the Effect of
film due to temperature on the
COATING Use mild drying System in
8 Blistering overheating either 4 strength, elasticity 3
condition
2 24
control
during spraying or at and adhesion of the
the end of the coating film
run

Format No.: CP/QA/010-F01/18-02

 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 6 of 7
Risk Assessment Protocol
Protocol No. Department

Decrease plasticizer
High concentration
Coating becomes dull concentration and System in
9 COATING Blooming
immediately
4 and low molecular 4
increase molecular
3 48
control
weight of plasticizer
weight of plasticizer

Use optimum and

Inefficient drying,
Adjacent tablets can efficient drying
higher rate of System in
10 COATING Picking stick together and then 5
application of
4 conditions or increase 3 60
control
break apart the inlet air
coating solution
temperature

Format No.: CP/QA/010-F01/18-02

 CONSERN PHARMA LIMITED, LUDHIANA
Focal Point, V.P.O. Tibba, District Ludhiana-141120, (Punjab), India Page
DEPARTMENT: QUALITY ASSURANCE 7 of 7
Risk Assessment Protocol
Protocol No. Department

5.0 ACTIONS GENERATED

6.0 SUMMARY & CONCLUSION

DESIGNATION NAME SIGNATURE DATE

APPROVED BY

AUTHORISED BY

Format No.: CP/QA/010-F01/18-02