Master Formula Record (MFR) & Bill of Material (BOM) – Pharma
The Master Formula Record (MFR) and Bill of Material (BOM) are essential documents in the pharmaceutical industry, providing comprehensive details for the formulation and manufacturing of pharmaceutical products. The MFR outlines the specific ingredients, quantities, and procedures required to produce a drug, ensuring consistency and compliance with regulatory standards. The BOM complements the MFR by […]
Site Acceptance Test (SAT) of Equipment
The Site Acceptance Test (SAT) plays a pivotal role in ensuring that individuals entering the pharmaceutical sector possess the requisite analytical skills, problem-solving abilities, and foundational knowledge necessary for success in various roles, including research and development, regulatory affairs, and quality assurance. Site Acceptance Test (SAT) Introduction Definition of Site Acceptance Test (SAT) “The Site […]
Pharmaceutical CMO Selection & Qualification
This comprehensive Standard Operating Procedure (SOP) is used to select and qualify Contract Manufacturing Organizations (CMOs) in the pharmaceutical industry. It also includes guidelines for establishing Quality Technical Agreements with CMOs to ensure compliance with regulatory requirements and quality standards. This SOP provides a systematic approach to CMO selection, evaluation, and ongoing quality management, helping […]
Lean Six Sigma Concept and Implementation
Lean Six Sigma (LSS) is the result of combining two procedures that were originally used independently to increase productivity and effectiveness in businesses. To put it briefly, Six Sigma is a data-driven approach that aims to produce a continuous process with few faults, and lean methodology aims to reduce or eliminate phases in a manufacturing […]
Safety Audit Procedure & Checklist
The Safety Audit Procedure and Checklist SOP is a comprehensive guide designed to ensure the systematic evaluation of safety practices within an organization. This document outlines the step-by-step process for conducting safety audits, including the preparation, execution, and follow-up phases. It features a detailed checklist covering critical safety aspects, enabling auditors to effectively identify potential […]
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 […]
Master Formula Record (MFR) & Bill of Material (BOM) – Pharma
The Master Formula Record (MFR) and Bill of Material (BOM) are essential documents in the pharmaceutical industry, providing comprehensive details for the formulation and manufacturing of pharmaceutical products. The MFR outlines the specific ingredients, quantities, and procedures required to produce a drug, ensuring consistency and compliance with regulatory standards. The BOM complements the MFR by […]
Site Acceptance Test (SAT) of Equipment
The Site Acceptance Test (SAT) plays a pivotal role in ensuring that individuals entering the pharmaceutical sector possess the requisite analytical skills, problem-solving abilities, and foundational knowledge necessary for success in various roles, including research and development, regulatory affairs, and quality assurance. Site Acceptance Test (SAT) Introduction Definition of Site Acceptance Test (SAT) “The Site […]
Pharmaceutical CMO Selection & Qualification
This comprehensive Standard Operating Procedure (SOP) is used to select and qualify Contract Manufacturing Organizations (CMOs) in the pharmaceutical industry. It also includes guidelines for establishing Quality Technical Agreements with CMOs to ensure compliance with regulatory requirements and quality standards. This SOP provides a systematic approach to CMO selection, evaluation, and ongoing quality management, helping […]
Lean Six Sigma Concept and Implementation
Lean Six Sigma (LSS) is the result of combining two procedures that were originally used independently to increase productivity and effectiveness in businesses. To put it briefly, Six Sigma is a data-driven approach that aims to produce a continuous process with few faults, and lean methodology aims to reduce or eliminate phases in a manufacturing […]
Safety Audit Procedure & Checklist
The Safety Audit Procedure and Checklist SOP is a comprehensive guide designed to ensure the systematic evaluation of safety practices within an organization. This document outlines the step-by-step process for conducting safety audits, including the preparation, execution, and follow-up phases. It features a detailed checklist covering critical safety aspects, enabling auditors to effectively identify potential […]
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 […]
Master Formula Record (MFR) & Bill of Material (BOM) – Pharma
The Master Formula Record (MFR) and Bill of Material (BOM) are essential documents in the pharmaceutical industry, providing comprehensive details for the formulation and manufacturing of pharmaceutical products. The MFR outlines the specific ingredients, quantities, and procedures required to produce a drug, ensuring consistency and compliance with regulatory standards. The BOM complements the MFR by […]
Site Acceptance Test (SAT) of Equipment
The Site Acceptance Test (SAT) plays a pivotal role in ensuring that individuals entering the pharmaceutical sector possess the requisite analytical skills, problem-solving abilities, and foundational knowledge necessary for success in various roles, including research and development, regulatory affairs, and quality assurance. Site Acceptance Test (SAT) Introduction Definition of Site Acceptance Test (SAT) “The Site […]
Pharmaceutical CMO Selection & Qualification
This comprehensive Standard Operating Procedure (SOP) is used to select and qualify Contract Manufacturing Organizations (CMOs) in the pharmaceutical industry. It also includes guidelines for establishing Quality Technical Agreements with CMOs to ensure compliance with regulatory requirements and quality standards. This SOP provides a systematic approach to CMO selection, evaluation, and ongoing quality management, helping […]
Lean Six Sigma Concept and Implementation
Lean Six Sigma (LSS) is the result of combining two procedures that were originally used independently to increase productivity and effectiveness in businesses. To put it briefly, Six Sigma is a data-driven approach that aims to produce a continuous process with few faults, and lean methodology aims to reduce or eliminate phases in a manufacturing […]
Safety Audit Procedure & Checklist
The Safety Audit Procedure and Checklist SOP is a comprehensive guide designed to ensure the systematic evaluation of safety practices within an organization. This document outlines the step-by-step process for conducting safety audits, including the preparation, execution, and follow-up phases. It features a detailed checklist covering critical safety aspects, enabling auditors to effectively identify potential […]
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 […]
About the author
Subscribe Us
Popular Categories
Categories
Follow Pharma Beginners
Recent Post
-
Master Formula Record (MFR) & Bill of Material (BOM) – PharmaOctober 29, 2024/0 Comments
-
Site Acceptance Test (SAT) of EquipmentSeptember 5, 2024/
-
Pharmaceutical CMO Selection & QualificationAugust 9, 2024/
-
Lean Six Sigma Concept and ImplementationAugust 5, 2024/
-
Safety Audit Procedure & ChecklistAugust 2, 2024/
-
AlCOA and ALCOA Plus Principles for Data IntegrityJuly 25, 2024/