1.0 PURPOSE

The Risk Assessment for HVAC System is initiated to identify the failure modes / process risks verify existing controls and provide recommendations for mitigation of residual risks, if any. This risk assessment shall emphasize on potential risks of Environment condition, contamination and cross-contamination of product during receiving, storage, processing and dispatch of the product/material with respect to HVAC system.

2.0 SCOPE

The scope of this document limited to the HVAC System installed at XYZ (Site Name)

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1.0 PURPOSE

The Risk Assessment for Water System is initiated to identify the failure modes / process risks verify existing controls and provide recommendations for mitigation of residual risks, if any. This risk assessment shall emphasize on potential risks of Purified water generation, storage, generation with respect to Water System.

2.0 SCOPE

The scope of this document limited to the Water System installed at XYZ.

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1.0 INTRODUCTION

WFI is generated from purified water in accordance with Ph EUR and cGMP. The generation of WFI is located in Utility Area. One loop is providing supply to all points of use in the facility/ dedicated areas in the facility. Water for Injection is used in sterile product production area for:

• Cleaning in process (CIP) of the solution preparation tanks,
• Storage tanks and machine filling lines solution preparation in OSD (granulation, coating).

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Water for Injection 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 Water for Injection 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

Nitrogen Gas Generation and Distribution systems are essential for pharmaceuticals industries. The below mentioned methods are used for the production of N2 Gas

Membrane Separation:

One common method for nitrogen generation is membrane separation, where compressed air is passed through semi-permeable membranes that selectively allow nitrogen molecules to pass through while retaining oxygen and other gases.

Pressure Swing Adsorption (PSA):

Another widely used method is PSA, where compressed air is passed through a bed of adsorbent material, such as carbon molecular sieves. The adsorbent selectively adsorbs oxygen and other trace gases, allowing nitrogen to pass through.

Cryogenic Distillation:

In this method, air is cooled to very low temperatures to liquefy it, and then the liquid air is separated into its components through fractional distillation. Nitrogen, having a higher boiling point than oxygen, is collected as a gas.

Nitrogen Gas Distribution:

Pipeline Distribution:

Nitrogen gas can be distributed through a network of pipelines connected to the generation system. These pipelines transport the gas to various points of use within the facility.

Cylinder Filling:

Nitrogen gas can also be stored and distributed in cylinders or tanks. These cylinders are filled with nitrogen gas at the generation site and transported to the point of use as needed.

On-Demand Generation:

Some facilities opt for on-site nitrogen generation systems, which produce nitrogen gas directly at the point of use. This eliminates the need for storage and transportation of nitrogen cylinders and ensures a continuous and reliable nitrogen supply.

Safety Measures:

Safety considerations, such as pressure relief valves, leak detection systems, and emergency shutdown procedures, are crucial to prevent accidents and ensure the safe operation of the system.

Monitoring and Control:

Advanced nitrogen generation systems are equipped with monitoring and control systems that continuously monitor parameters such as pressure, purity, and flow rate. These systems allow for real-time adjustments to optimize performance and ensure consistent gas quality.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Nitrogen Gas Generation and Distribution 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 Nitrogen Gas Generation and Distribution 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

Pure steam systems are critical components in industries such as pharmaceuticals, biotechnology, healthcare, and food processing. They are used for sterilization, cleaning, and humidification processes where the presence of impurities can compromise product quality or safety. Pure steam is essentially water vapor that is free from impurities, including minerals, dissolved gases, and particulate matter.

Design:

Boiler: The heart of a pure steam system is a specially designed boiler capable of producing high-purity steam. These boilers are typically made of stainless steel and feature sophisticated purification systems to ensure that the steam produced meets stringent quality standards.

Distribution System: Once generated, pure steam is distributed throughout the facility via a network of pipes and valves. The distribution system is designed to prevent contamination and maintain the purity of the steam.

Condensation System: After performing its intended function, pure steam condenses back into water. A condensation system collects and removes this condensate, ensuring that any impurities that may have been picked up during the process are effectively removed.

Monitoring and Control Systems: Modern pure steam systems are equipped with advanced monitoring and control systems that continuously monitor steam quality, temperature, pressure, and flow rates. These systems help ensure that the steam meets the required specifications and allow for real-time adjustments as needed.

Description:

Pure steam systems are designed to produce steam with a high degree of purity, typically exceeding the requirements of pharmacopeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). The design and construction of these systems are meticulously engineered to minimize the risk of contamination and ensure the consistent production of high-quality steam.

Principle of Operation:

Water Purification: The process begins with the purification of feed water to remove impurities such as minerals, dissolved gases, and organic matter. This is typically achieved through a combination of methods such as reverse osmosis, ion exchange, and distillation.

Steam Generation: Purified water is heated in the boiler to generate steam. The boiler is designed to produce steam at high temperatures and pressures, effectively sterilizing the steam and ensuring its purity.

Steam Distribution: The pure steam is then distributed throughout the facility via a network of pipes and valves. Careful attention is paid to the design and materials used in the distribution system to minimize the risk of contamination.

Condensation: After performing its intended function, the pure steam condenses back into water. The condensate is collected and removed from the system to prevent the accumulation of impurities.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Pure Steam 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 Pure Steam 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

The air generated from the air compressor system and stored in the air receiver tank shall meet the specified requirements at the connection point of the distribution. This point shall be after the pressure reducing station. The quality is to be maintained throughout the distribution system to the points of use.

Compressed air  will be for following applications:

• General cleaning and drying purposes
• In oral solid dosage area for tablet production and coating e.g. during dedusting of tablets and spray on tablet coatings
• In production equipment such as mixing or holding tanks, to maintain over-pressurization and ensure product integrity / sterility
• In direct operation with the product and/ or package. For instance, during product filling/ dosing, blister packaging or bottling throughout the production facility
• As power source for pneumatic drives
• To operate pneumatic valves at equipment throughout the facility. Pneumatic valves will be part of the production equipment as well as the utility equipment.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Compressed air Generation and Distribution 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 Compressed air Generation and Distribution 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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