AlCOA and ALCOA Plus Principles for Data Integrity
Brief Explanation of AlCOA and ALCOA Plus Principles for Data Integrity The AlCOA and ALCOA Plus Principles for Data Integrity provide a framework for ensuring the accuracy and reliability of data in regulated environments. AlCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, while ALCOA Plus includes the additional principles of Complete, Consistent, Enduring, and […]
SCADA System Operation in Water System
The SCADA system for water purification is designed to efficiently monitor and control the various processes involved in treating water. It allows operators to remotely access and manage the purification system, ensuring that water quality is consistently maintained. The system provides real-time data on water levels, flow rates, and chemical dosing, enabling quick response to […]
GAMP 5 – Concept and Implementation
The GAMP 5 life cycle is a comprehensive framework that outlines the various phases involved in the development, implementation, and maintenance of computer systems and software used in regulated industries, such as the pharmaceutical and medical device sectors. This life cycle is structured around five distinct phases, each with its own unique objectives and activities. […]
Dispensing Area Fumigation Procedure
The dispensing area fumigation procedure in pharmaceuticals involves using specialized chemicals to eliminate microbial contamination in production areas, equipment, and storage facilities. This process is crucial for maintaining a sterile environment and ensuring the quality and safety of pharmaceutical products. By effectively targeting and destroying harmful microorganisms, fumigation helps to prevent contamination and maintain compliance […]
Dispensing Area : Cleaning & Riser Filters Replacement
Optimize your pharmaceutical operations with our SOP for cleaning the Raw Material Dispensing area and replacing filters. Ensure cleanliness and adherence to industry standards. Efficiently clean the Raw Material Dispensing area and replace filters detailed SOP. Stay compliant and maintain a cGMP environment. Cleaning of Dispensing Area and Return Filters Replacement 1.0 Objective To lay […]
Packing Materials Handling Procedure
The pharmaceutical packing materials handling procedure ensures the safe and efficient handling of all packaging materials used in the production of pharmaceutical products. Our strict adherence to industry regulations and best practices guarantees the integrity and quality of the materials, ultimately contributing to the safety and efficacy of the final pharmaceutical products. Receipt and Storage […]
API and Excipients – Receipt and Storage
This Standard Operating Procedure (SOP) outlines the guidelines for the receipt and storage of raw materials, including Active Pharmaceutical Ingredients – API and Excipients, in the pharmaceutical industry Receipt and Storage of Raw Materials (API and Excipients) 1.0 Purpose To lay down the procedure for receipt & storage of Raw Materials (API and Excipients). 2.0 […]
Aspect and Impact Analysis (ISO -14001:2015)
Environmental Aspect and Impact Analysis procedure SOP is a comprehensive document that outlines the steps to identify, evaluate, and control environmental aspects and impacts within an organization. This SOP provides clear guidance on how to assess the potential environmental effects of activities, products, and services, and how to develop effective control measures to minimize negative […]
Artwork Management Procedure
This SOP for Artwork Management in pharmaceuticals ensures that all artwork related to our products meets regulatory requirements and is consistently high quality. This includes processes for artwork creation, review, approval, storage, and guidelines for version control and change management. By following this SOP, we can ensure that our pharmaceutical packaging and labeling comply with […]
Pharmacovigilance – Market Complaint (EU)
Learn about the market complaint handling process for EU products and pharmacovigilance on our website. Expert guidance and resources available. 2. Discover best practices for managing market complaints for EU products and pharmacovigilance on our website. Stay informed and compliant with regulations. 3. Access valuable information on market complaint procedures for EU products and pharmacovigilance […]
Drain Point – Microbial Monitoring Procedure
Learn about the essential steps for microbial monitoring of drain point in the pharmaceutical industry. Ensure compliance and safety with our detailed procedures. Gain insights into the importance of microbial monitoring at drain points in the pharmaceutical sector. Enhance product safety and mitigate contamination risks effectively. Microbiological Monitoring of Drain Points 1.0 Purpose To lay […]
Compressed Air Validation Protocol
Compressed air validation is recorded evidence that such parameters as aerosol particle content, dew point, liquid water concentration, vapor content, oil aerosols, and other pollutants are within limits and do not cause product contamination. Validation of Compressed Air 1.0 Objective The purpose of this protocol is to provide the procedure for the Validation of compressed […]
Biological Safety Cabinet – Qualification
In microbiology labs, a biological safety cabinet (BSC) is an essential part of the apparatus. Experts can safely handle harmful biological agents and carry out procedures that safeguard the person conducting the study and the surrounding environment within its ventilated, enclosed workplace. The biological safety cabinet protects against product, personnel, and cross-contamination by using directional airflow […]
Bacterial Endotoxin (LAL) Test Procedure
d Standard Operating Procedure (SOP) for Bacterial Endotoxin (LAL) Test in microbiology for pharmaceutical and healthcare laboratories and food industry. With our comprehensive Bacterial Endotoxin (LAL) Test Procedure, you may expedite your testing process and ensure consistent, dependable results. Procedure for Bacterial Endotoxin (LAL) Test 1.0 Purpose The objective of this SOP is to lay […]
Quality Monitoring of Water (Raw & Portable)
The production of pharmaceuticals depends on water. Quality Monitoring the of both raw and portable water is crucial at every stage to guarantee patient safety. Scientists utilize sophisticated equipment to screen for chemical and microbiological pollutants, just like detectives follow hints. They are aware that even minute contaminants can change a medication’s purity and efficacy. […]
AlCOA and ALCOA Plus Principles for Data Integrity
Brief Explanation of AlCOA and ALCOA Plus Principles for Data Integrity The AlCOA and ALCOA Plus Principles for Data Integrity provide a framework for ensuring the accuracy and reliability of data in regulated environments. AlCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, while ALCOA Plus includes the additional principles of Complete, Consistent, Enduring, and […]
SCADA System Operation in Water System
The SCADA system for water purification is designed to efficiently monitor and control the various processes involved in treating water. It allows operators to remotely access and manage the purification system, ensuring that water quality is consistently maintained. The system provides real-time data on water levels, flow rates, and chemical dosing, enabling quick response to […]
GAMP 5 – Concept and Implementation
The GAMP 5 life cycle is a comprehensive framework that outlines the various phases involved in the development, implementation, and maintenance of computer systems and software used in regulated industries, such as the pharmaceutical and medical device sectors. This life cycle is structured around five distinct phases, each with its own unique objectives and activities. […]
Dispensing Area Fumigation Procedure
The dispensing area fumigation procedure in pharmaceuticals involves using specialized chemicals to eliminate microbial contamination in production areas, equipment, and storage facilities. This process is crucial for maintaining a sterile environment and ensuring the quality and safety of pharmaceutical products. By effectively targeting and destroying harmful microorganisms, fumigation helps to prevent contamination and maintain compliance […]
Dispensing Area : Cleaning & Riser Filters Replacement
Optimize your pharmaceutical operations with our SOP for cleaning the Raw Material Dispensing area and replacing filters. Ensure cleanliness and adherence to industry standards. Efficiently clean the Raw Material Dispensing area and replace filters detailed SOP. Stay compliant and maintain a cGMP environment. Cleaning of Dispensing Area and Return Filters Replacement 1.0 Objective To lay […]
Packing Materials Handling Procedure
The pharmaceutical packing materials handling procedure ensures the safe and efficient handling of all packaging materials used in the production of pharmaceutical products. Our strict adherence to industry regulations and best practices guarantees the integrity and quality of the materials, ultimately contributing to the safety and efficacy of the final pharmaceutical products. Receipt and Storage […]
API and Excipients – Receipt and Storage
This Standard Operating Procedure (SOP) outlines the guidelines for the receipt and storage of raw materials, including Active Pharmaceutical Ingredients – API and Excipients, in the pharmaceutical industry Receipt and Storage of Raw Materials (API and Excipients) 1.0 Purpose To lay down the procedure for receipt & storage of Raw Materials (API and Excipients). 2.0 […]
Aspect and Impact Analysis (ISO -14001:2015)
Environmental Aspect and Impact Analysis procedure SOP is a comprehensive document that outlines the steps to identify, evaluate, and control environmental aspects and impacts within an organization. This SOP provides clear guidance on how to assess the potential environmental effects of activities, products, and services, and how to develop effective control measures to minimize negative […]
Artwork Management Procedure
This SOP for Artwork Management in pharmaceuticals ensures that all artwork related to our products meets regulatory requirements and is consistently high quality. This includes processes for artwork creation, review, approval, storage, and guidelines for version control and change management. By following this SOP, we can ensure that our pharmaceutical packaging and labeling comply with […]
Pharmacovigilance – Market Complaint (EU)
Learn about the market complaint handling process for EU products and pharmacovigilance on our website. Expert guidance and resources available. 2. Discover best practices for managing market complaints for EU products and pharmacovigilance on our website. Stay informed and compliant with regulations. 3. Access valuable information on market complaint procedures for EU products and pharmacovigilance […]
Drain Point – Microbial Monitoring Procedure
Learn about the essential steps for microbial monitoring of drain point in the pharmaceutical industry. Ensure compliance and safety with our detailed procedures. Gain insights into the importance of microbial monitoring at drain points in the pharmaceutical sector. Enhance product safety and mitigate contamination risks effectively. Microbiological Monitoring of Drain Points 1.0 Purpose To lay […]
Compressed Air Validation Protocol
Compressed air validation is recorded evidence that such parameters as aerosol particle content, dew point, liquid water concentration, vapor content, oil aerosols, and other pollutants are within limits and do not cause product contamination. Validation of Compressed Air 1.0 Objective The purpose of this protocol is to provide the procedure for the Validation of compressed […]
AlCOA and ALCOA Plus Principles for Data Integrity
Brief Explanation of AlCOA and ALCOA Plus Principles for Data Integrity The AlCOA and ALCOA Plus Principles for Data Integrity provide a framework for ensuring the accuracy and reliability of data in regulated environments. AlCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, while ALCOA Plus includes the additional principles of Complete, Consistent, Enduring, and […]
SCADA System Operation in Water System
The SCADA system for water purification is designed to efficiently monitor and control the various processes involved in treating water. It allows operators to remotely access and manage the purification system, ensuring that water quality is consistently maintained. The system provides real-time data on water levels, flow rates, and chemical dosing, enabling quick response to […]
GAMP 5 – Concept and Implementation
The GAMP 5 life cycle is a comprehensive framework that outlines the various phases involved in the development, implementation, and maintenance of computer systems and software used in regulated industries, such as the pharmaceutical and medical device sectors. This life cycle is structured around five distinct phases, each with its own unique objectives and activities. […]
Dispensing Area Fumigation Procedure
The dispensing area fumigation procedure in pharmaceuticals involves using specialized chemicals to eliminate microbial contamination in production areas, equipment, and storage facilities. This process is crucial for maintaining a sterile environment and ensuring the quality and safety of pharmaceutical products. By effectively targeting and destroying harmful microorganisms, fumigation helps to prevent contamination and maintain compliance […]
Dispensing Area : Cleaning & Riser Filters Replacement
Optimize your pharmaceutical operations with our SOP for cleaning the Raw Material Dispensing area and replacing filters. Ensure cleanliness and adherence to industry standards. Efficiently clean the Raw Material Dispensing area and replace filters detailed SOP. Stay compliant and maintain a cGMP environment. Cleaning of Dispensing Area and Return Filters Replacement 1.0 Objective To lay […]
Packing Materials Handling Procedure
The pharmaceutical packing materials handling procedure ensures the safe and efficient handling of all packaging materials used in the production of pharmaceutical products. Our strict adherence to industry regulations and best practices guarantees the integrity and quality of the materials, ultimately contributing to the safety and efficacy of the final pharmaceutical products. Receipt and Storage […]
API and Excipients – Receipt and Storage
This Standard Operating Procedure (SOP) outlines the guidelines for the receipt and storage of raw materials, including Active Pharmaceutical Ingredients – API and Excipients, in the pharmaceutical industry Receipt and Storage of Raw Materials (API and Excipients) 1.0 Purpose To lay down the procedure for receipt & storage of Raw Materials (API and Excipients). 2.0 […]
Aspect and Impact Analysis (ISO -14001:2015)
Environmental Aspect and Impact Analysis procedure SOP is a comprehensive document that outlines the steps to identify, evaluate, and control environmental aspects and impacts within an organization. This SOP provides clear guidance on how to assess the potential environmental effects of activities, products, and services, and how to develop effective control measures to minimize negative […]
Artwork Management Procedure
This SOP for Artwork Management in pharmaceuticals ensures that all artwork related to our products meets regulatory requirements and is consistently high quality. This includes processes for artwork creation, review, approval, storage, and guidelines for version control and change management. By following this SOP, we can ensure that our pharmaceutical packaging and labeling comply with […]
Pharmacovigilance – Market Complaint (EU)
Learn about the market complaint handling process for EU products and pharmacovigilance on our website. Expert guidance and resources available. 2. Discover best practices for managing market complaints for EU products and pharmacovigilance on our website. Stay informed and compliant with regulations. 3. Access valuable information on market complaint procedures for EU products and pharmacovigilance […]
Drain Point – Microbial Monitoring Procedure
Learn about the essential steps for microbial monitoring of drain point in the pharmaceutical industry. Ensure compliance and safety with our detailed procedures. Gain insights into the importance of microbial monitoring at drain points in the pharmaceutical sector. Enhance product safety and mitigate contamination risks effectively. Microbiological Monitoring of Drain Points 1.0 Purpose To lay […]
Compressed Air Validation Protocol
Compressed air validation is recorded evidence that such parameters as aerosol particle content, dew point, liquid water concentration, vapor content, oil aerosols, and other pollutants are within limits and do not cause product contamination. Validation of Compressed Air 1.0 Objective The purpose of this protocol is to provide the procedure for the Validation of compressed […]
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AlCOA and ALCOA Plus Principles for Data IntegrityJuly 25, 2024/0 Comments
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SCADA System Operation in Water SystemJuly 24, 2024/
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GAMP 5 – Concept and ImplementationJuly 23, 2024/
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Dispensing Area : Cleaning & Riser Filters ReplacementJuly 20, 2024/
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