1.0 INTRODUCTION

The intended use of sampling booth is to obtain isolated and protected areas that are needed during sampling of pharmaceuticals raw materials.

By the impulsion of clean air during sampling of materials these 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.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the sampling booth with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of sampling booth and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

This filling machine is intended for use in bio specialty to fill and stopper pre-sterilized syringes / vials.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Automatic Syringe Filling and Vial Filling Machine with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Automatic Syringe Filling and Vial Filling Machine and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

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.

Solution compounding comprises with the following components: -

• Vessel - incl. stirrer (compounding vessel) for syringe
• Compounding vessel with stirrer
• Transfer Pump

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Solution Compounding Vessels with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Solution Compounding Vessels and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

Depyrogenation tunnels designed to sterilize and dehydrogenate glass containers with a continuous process maintaining an ISO 5 environment along with whole length and the width of the conveyor belt complying ISO 14644-1 requirements. The Out-feed of the vial Washing machine is integrated with the vials depyrogenation tunnel. The Tunnel is designed to depyrogenate glass vials of various sizes by means of a continuous process using HEPA filtered, dry and hot unidirectional air-flow. The air temperature within the sterilizing zone of the tunnel sterilizer is maintained in a rage of 320°C to 360°C. An ISO 5 (Class 100) environment according to ISO 14644-1 requirements is maintained inside the entire length of the tunnel.

The washed glass vials are transported into the sterilizing tunnel by a conveyor belt constructed of stainless-steel wire mesh with lateral guides that avoids the vial from sliding along the tunnel walls. The tunnel is constructed of stainless steel AISI 316 and AISI 304 steel panels. The conveyor speed can be adjusted according to the vial size and configuration. Maximum conveyor speed of 200 mm per minute can be achieved.

The sealing of the HEPA filters is achieved by using ceramic fiber gaskets. The area around the frames of the HEPA filters is connected to the air inlet of the corresponding fan to create a required pressure gradient across the HEPA filter, this helps avoiding accidental infiltration of non-sterile air through the gaskets.

Adjustable flaps within the hot chambers ensures uniformity of air velocity and laminarity of the inlet air filtered through the HEPA filters, this helps ensuring uniform heat distribution across the heating chamber.

All process control parameters are continuously monitored, automatically controlled and printed.

The depyrogenation process helps in inactivation of bacterial endotoxin to a log reduction value of not less than 3 logs. The process of depyrogenation of glass vials required to be validated as per GMP guidelines.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Vial Depyrogenation Tunnel with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Vial Depyrogenation Tunnel and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

High-speed linear or rotatory vial washing machine is used for the washing of the vials. Vials are washed according to a set and validated sequence at different washing stations using purified water, sterile filtered compressed air and final rinse with Water for Injection. All parts coming in contact with washing zone/ jet are constructed of stainless steal 316. The vial washing machine is controlled by a PLC, which contains validated program(s) for the washing of different size glass vials. High-pressure spray jet/nozzles enter into the vials and ensure the perfect wash and entire washing process can be observed from a transparent glass window.

The vials are washed from both sides i.e. inside and outside of the vial by using high pressure jet/nozzle, containing media defined for that specific washing station, i.e. filtered, (re)circulated purified water, purified water, compressed air and water for injection. A typical washing method at a washing station is shown in the following figure 3.

The vials from the in-feed gets inverted and positioned into a pocket, which then moves to the sequence of washing stations. At each washing station, the vial stops, the nozzles manifold raises up and nozzles enter into the mouth of each vial. A solenoid valve in the water and compressed air line operates and a jet of air/water is introduced inside and outside of the vials. A standard washing cycle sequence is explained in following table 1:

Table 1: Vial Washing Sequence

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Vial washing machine with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Vial Washing Machine and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

Vial filling and stoppering machines automate the process of filling vials with liquid or powder medications, chemicals, or other substances, and sealing them with stoppers or caps. The machine is designed to ensure accuracy, consistency, and sterility throughout the filling process, reducing human error and contamination risks.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Vial Filling and Sealing machine with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Vial Filling and Sealing Machine and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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1.0 INTRODUCTION

Autoclaves used for sterilize the components, lab equipment, glassware, media etc. The steam enters the chamber jacket, passes through an operating valve and enters the rear of the chamber behind a baffle plate. It flows forward and down through the chamber and the load, exiting at the front bottom. A pressure regulator maintains jacket and chamber pressure at a minimum of 1.04 bar, the pressure required for steam to reach 121°C. Overpressure protection is provided by a safety valve. The conditions inside are thermostatically controlled so that heat (more steam) is applied until 121°C is achieved, at which time the timer starts, and the temperature is maintained for the selected time.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Autoclave machine with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Autoclave and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

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

10.2 Risk Analysis

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

10.2.1 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).

10.2.2 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).

10.2.3 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).

10.3 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:

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​1.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the High Perfromance Chromatography (HPLC) 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 igh Perfromance Chromatography (HPLC)  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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​1.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Gas Chromatography (GC) 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 Gas Chromatography (GC)  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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​1.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Automated Storage and Retrieval System (ASRS) 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 Automated Storage and Retrieval System (ASRS)  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

For Complete Risk Assesment Document, Click on Readmore, Subscrbe and Download