​1.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Risk Assessment for Fourier Transform Infrared Spectrophotometer (FTIR) with the guidance of the Risk Management manual of and ICH Q9.

2.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Risk Assessment for Fourier Transform Infrared Spectrophotometer (FTIR)  and identify its failure mode.

10.0 RISK MANAGEMENT TOOL

10.1 Qualitative Risk Management

10.1.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.1.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.1.3 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.1.4 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.1.5 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.1.5 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

The Overall Risk Level is defined according to Combination of Severity and Occurrence to get a Risk Class first and then Combination of Risk Class & Detectability to determine overall risk

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1.References

• Plant Validation Mater Plan                 Doc. ID.:                      
• Master Qualification Plan                    Doc. ID.:                      
• User Requirement Specification         Doc. ID.:          

2.System description

The intended use of Dispensing Booth is to obtain isolated and protected areas that are needed during dispensing of pharmaceuticals raw materials.

By the impulsion of clean air during dispensing of materials three protection levels are reached:

• The operator is protected against the inhalation of pharmaceutical raw materials.
• The handled product is also protected, as it is placed in a Grade A clean air area.
• As the cabinet is negative pressurized, there is no possibility of cross-contamination with other areas. Also the environment is unharmed as the exhaust air to outside passes through a HEPA filter.

3.Scope

The risk assessment is valid for

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Media

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

1.References

• Plant Validation Mater Plan                    Doc. ID.:                      
• Master Qualification Plan                       Doc. ID.:                      
• User Requirement Specification             Doc. ID.:                      

2.System description

Granulation Suite mainly comprises with High shear Granulator, wet mill,vacuum conveying system andfluid bed dryer (FBD).

The pharmaceutical productAPI in powder form first sieved and dispensed under isolator condition in a catch pot and excipient in dispensing booth. The catch pot then docked at granulator through containment valve for discharging of the active part in granulator so as for excipient to form wet granulates. The wet granules discharged from granulator to FBD through wet mill. In fluid bed dryer wet granulates are fluidized to dry.

The granules dried at required temperature and time to attain specified moisture level as per the requirement of the product.

The dried granulates are discharged from FBD bowl to IBC by vacuum conveying system.

The IBC then dock at the dry sieve through the lifting and tilting device for dry sieving of the dry granules to get the desired size material

Both aqueous and organic solvents will use in this suite.

Granulation machine shall be designed as a high containment machine (OEB: 4 and 5).

3.Scope

The risk assessment is valid for Granulation Suite

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Media

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

1.References

• Plant Validation Mater Plan                    Doc. ID.:                      
• Master Qualification Plan                       Doc. ID.:                      
• User Requirement Specification             Doc. ID.:          

2.System description

The intended use of mist shower is to protect the person from highly toxic substance during de-gowning of clothes. Mist shower (fogging and misting mode) reduce the potential of airborne exposure during de-gowning of contaminated garments

3.Scope

The risk assessment is valid for

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Media

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

1.References

• Plant Validation Mater Plan                 Doc. ID.:          
• Master Qualification Plan                    Doc. ID.:          
• User Requirement Specification          Doc. ID.:          

2.System Description

Solution preparation system comprises with the following components:

Raw material (API + excipients) dispended in bags or small containers are charged into solution preparation vessel manually under laminar air flow for final solution preparation.

The final formulation is prepared in vessel by mixing / compounding different ingredients as per the desired mixing time.

3.Scope

The risk assessment is valid for solution preparation system.

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Utility

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

1.References

• Plant Validation Mater Plan                 Doc. ID.:          
• Master Qualification Plan                    Doc. ID.:          
• User Requirement Specification          Doc. ID.:          

2.System Description

Powder filling system comprises with the following components:

3.Scope

The risk assessment is valid for powder filling system

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Utility

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

1.References

• Plant Validation Mater Plan - P-VMP                Doc. ID.:          
• Master Qualification Plan – MQP                     Doc. ID.:          
• User Requirement Specification                      Doc. ID.:          

2.System Description

Bottle washing machine and filling system comprises with the following components:

3.Scope

The risk assessment is valid for Bottle washing and filling system

The installation place is as follows:

4.Definition of Critical Components, Parameters and Functions

The risk assessment will be performed by reference to the impact of critical components, parameters and functions to the product quality.

Critical Components:

Test Item 6.1 Process Utility

Test Item 6.2 Design and Construction

Test Item 6.3 Control System

Critical Parameters:

Test Item 6.4 Critical Process Parameters

Critical Functions:

Test Item 6.5 User interface / function

5.Risk Assessment

The Overall Risk Level must be graded as low (L), medium (M) and high (H) according to combination of Severity and Occurrence to get a Risk Class (class 1, 2 ,3) first and then combination of Risk Class & Detectability to determine overall risk level. The overall risk level defines the risk to be acceptable, un-acceptable and intolerable in accordance to the regulations of Attachment 3 of Plant Validation Master Plan. Consequently the risk must be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below: