PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

RISK ASSESSMENT
REPORT BY FMEA

Product/System/Equipment RAPID MIXER GRANULATOR

(600 LTR. & 1200 LTR.)
Risk Assessment Report No.
Report Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

TABLE OF CONTENTS

S.No. Description Page No.

1.0 Introduction 4

2.0 Objective 4

3.0 Scope 4

4.0 Risk Assessment Approach 4

5.0 Responsibility 4

6.0 Reference Documents 5

Risk Ranking Parameters
7.0 5

8.0 Acceptance Criteria for risk assessment by FMEA 7

9.0 Risk assessment as per FMEA 8

9.1 Review of Risk assessment as per FMEA after action taken. 12

Risk Control Measures
10.0 13

11.0 Summary and Conclusion Report for Risk Assessment 14

12.0 Final Report Approval 15

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

DOCUMENT APPROVAL:
This risk analysis study for the preapproval of report by following:

Responsibility Department Name Signature Date

Prepared by Quality assurance

Production

Quality control

Reviewed by Engineering

Store

Quality assurance

Approved by Head-QA
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

1.0 Introduction
THE “Rapid Mixer Granulator” is intended for the manufacturing of oral dosage form. The goal
is to obtain uniform mixing of drug and excipient in Dry granulation as well as Wet granulation
by adding binder to achieve desired granules with assurance of product quality & safety.

2.0 Objective
Objective of this report is to assess the risk associated with the equipment “Rapid Mixer
granulator” in pre assessment in the manufacturing facility of Cepha Block of ……………, in
line with the guidance of the Risk Management manual of …………….of ICH Q9.

3.0 Scope
The scope of this document is limited to the design, installation, operation, performance and
safety of equipment “Rapid Mixer Granulator” and define its failure mode at pre assessment in
the manufacturing facility of Cepha Block at …………..

4.0 Risk assessment approach

Risk assessment is carried out as per FMEA (Failure mode, effects analysis) method.

5.0 Responsibility
Quality Assurance
Engineering
Production
Quality Control
Store

6.0 Reference Documents

1. ICH Q9-Quality Risk Management

2. ……………..pharmaceutical guidance on Risk assessment.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

Background

……………….. is intended to start manufacturing of solid oral facility at ……………….. Risk

assessment is a part of corporate quality assurance. Pre Quality Risk assessment of “Rapid Mixer
granulator” is done to check the system is capable of providing quality product throughout the life cycle of
the drug product.

7.0 RISK RANKING PARAMETERS

7.1 Rating parameters for Severity

Effect Scale Description

No effect 1 No effect on output

Very slight 2 Customer not annoyed

Slight 3 Slight

Minor 4 Minor effect on performance

Moderate 5 Moderate effect on performance

Significant 6 Partial failure but operable

Major 7 Product performance severely affected, but some operability and safe

Extreme 8 Very dissatisfied, product inoperable but safe

Serious 9 Potentially hazardous effect, time-dependent failure

Hazardous 10 Hazardous effect, safety related sudden failure

7.2 Rating parameters for Occurrence

Occurrence Scale Description

Almost never 1 Failure unlikely; history shows no failures

Remote 2 Rare number of historical failure

Very Slight 3 Very few failures likely

Slight 4 Few failures likely

Low 5 Occasional number of failures likely

Medium 6 Medium number of failures likely

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

Occurrence Scale Description

Moderately High 7 Moderately high number of failures likely

High 8 High number of failures likely

Very High 9 Very high number of failures likely

Almost certain 10 Failure almost certain

7.3 Rating parameters for Detection control

Detection Scale Description

Almost certain 1 Proven detection methods with high reliability

Very High 2 Proven detection methods available

High 3 Detection tools have high chance of detecting methods

Moderately High 4 Almost certain not to detect failure

Medium 5 Detection tools have moderate chance of detecting defect

Low 6 Detection tools have a low chance of detecting failure

Slight 7 Detection tools may not detect failure

Very Slight 8 Detection tools will probably not detect failure

Remote 9 Detection tools most likely will not detect failure

Impossible 10 Failure not detected

Note: Individual contributory factor for each potential failure mode shall be rated. Other scale parameters
may also be selected based on the process.

8.0 ACCEPTANCE CRITERIA FOR RISK ASSESSMENT BY FMEA

Acceptance criteria for FMEA are as follows:

S.No. RPN Rating RPN Category Action Status

1. ≥ 76 Critical CAPA Required

2. 51 to 75 Major CAPA Required

3. 26 to 50 Moderate CAPA Required

4. Up to 25 Minor Not applicable

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

9.0 PRE-RISK ASSESSMENT AS PER FMEA:
Name of facility/Utility/Equipment/Process/Operation: Rapid Mixer Granulator

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Required Area Area will not be 6 No or less clarity of the 3 Approved layout is in 3 54 Care has to be
(floor, suitable for proper product requirement and place with taken during
Temperature, functioning of machine functionality. dimensions & Area
RH, Equipment. required Qualification
Differential environmental
1 pressure) not condition
proper for the
RMG

Required Systems not 4 No or less clarity of the 3 Preparation of URS 2 24 Current control NA NA NA NA NA NA
parameter not receive suitable product requirement and before procurement measures are
defined in for proper output machine functionality. of equipment is in adequate
URS. URS not of quality with all place with all pre-
2
proper for parameter as per specified parameter.
system specification.
Affect the product
quality.
Required Machine will not 7 No or less clarity of the 2 URS is in place for 1 14 Current control NA NA NA NA NA NA
utilities function as product requirement and system with all measures are
(compressed expected. machine functionality with predefined adequate
3 air, purified respect to utility requirement of utility
water, requirement. like water, electricity,
electricity) are compressed air.
not available
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Wrong Installation will 6 No or less clarity of the 2 URS is in place for 1 12 Current control NA NA NA NA NA NA
machine be affected if machine. dimension , capacity measures are
selection in dimension is not and rated output of adequate
terms of considered. the of the RMG
4
Dimension, Output will also
capacity and get affected if
output. capacity is not
considered.
MOC and Not meeting GMP 7 No or less clarity of the 3 URS is in place for 1 21 Current control NA NA NA NA NA NA
machine requirements and machine contact part and MOC (contact part measures are
contact parts product get MOC. should be of SS316 adequate
not meeting affected. or 316L and non
GMP contact parts will be
5 requirement of SS304 and
machine contact parts
to fulfill GMP
requirements. Gasket
used shall be of food
grade rubber.
Impeller Up & Improper cleaning 4 No or less clarity about 3 2 24 Current control NA NA NA NA NA NA
down and product get equipment Requirement of measures are
movement not affected. Impeller Up & down adequate
provided movement is defined
6
in URS
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Equipment not Accident may 10 No or less clarity about 2 Requirement of 1 20 Current control NA NA NA NA NA NA
received with happen. equipment safety Safety measures like measures are
the safety measures. interlocking for adequate
7 measures. purging air, LID ,
Side guard, discharge
port is defined in
URS.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

9.1 REVIEW OF RISK ASSESSMENT AS PER FMEA AFTER ACTION TAKEN:

Action Results Remarks

Action Taken Severity Occurrence Detectability RPN

10.0 RISK CONTROL MEASURES

Investigation/ findings: (an extra sheet can be used if space is insufficient)

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

Corrective Action: (an extra sheet can be used if space is insufficient)

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

(Sign/Date)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

11.0 SUMMARY AND CONCLUSION REPORT FOR RISK ASSESSMENT

Summary:

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

Conclusion:………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSEMENT FOR RMG

12.0 FINAL REPORT APPROVAL:

The final report shall be signed after identifying all the risks and critical control parameters. All the reports
or documents have been attached to the respective report (if applicable).

Signature in the block below indicates that all the control measures taken are documented and have been
reviewed and found to be acceptable.

Department Name Designation Signature Date

Quality assurance

Production

Quality control

Utility

Store

Head-QA