This document summarizes ISPE's guides on cleaning and cleaning validation. It discusses ISPE's Risk-MaPP guide and how it introduces health-based limits for residues that are applied to cleaning. It also provides an overview of the status of ISPE's Cleaning Baseline Guide, explaining that it did not receive sufficient regulatory review to be published as a Baseline Guide. Finally, it announces that ISPE is forming a team to develop a new Good Practice Guide on cleaning that will provide specific guidance and examples on cleaning practices and validation.
The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
This document discusses cleaning validation requirements from a regulatory perspective. It provides an overview of key concepts in cleaning validation including establishing health-based exposure limits and determining maximum allowable carryover levels. A risk-based approach using bracketing and worst-case determination is recommended. Common deficiencies observed include inadequate hazard assessment, lack of justification for cleaning approaches, and failure to revalidate cleaning when processes change. International GMPs are incorporating guidelines for setting health-based exposure limits to ensure contamination risks are properly managed.
this presentation contains information about HACCP implementation in food industry. with example, easy to understand comment below how is this presentation
The document discusses several topics related to quality assurance of drugs, including emerging trends, key recommendations, tasks for corporate quality assurance units, communication strategies, validation variations, product integrity, managing suppliers and third parties, hazard analysis and critical control points (HACCP), guidelines for applying HACCP, and good automated manufacturing practices (GAMP). Some of the main points discussed are the changing quality assurance environment and need for continuous improvement, effective communication across the organization, risk-based auditing, ensuring product validation is continuously updated, and employing quality control and validation strategies according to ICH standards.
This document outlines the steps for cleaning validation in a GMP pharmaceutical manufacturing plant. It discusses establishing cleaning procedures and validation programs to ensure no carryover of active ingredients between products. Key steps include: identifying equipment to validate, selecting worst-case products, calculating acceptance limits for rinse and swab samples based on product toxicity, and conducting analytical method validation including rinse and swab recovery studies. The purpose is to demonstrate cleaning processes consistently remove residues to acceptable levels between product batches.
This document discusses risk analysis and HACCP systems. It defines risk as a function of the probability and severity of adverse health effects from hazards in food. It outlines the components of risk analysis: risk assessment, risk management, and risk communication. It then details the steps of risk assessment and describes how risk assessment should consider relevant practices throughout the food chain. It also discusses risk management, risk communication, and provides a diagram of the risk analysis process. Finally, it outlines the principles and benefits of implementing a HACCP system.
Contamination Control Cleaning Validation.pdfHassanHani5
This presentation discusses cleaning validation, including potential contaminants, regulatory requirements, challenges, and continuous process verification programs. It outlines the scope of a cleaning validation program, including validation plans, sampling strategies, and continued process verification. An example continuous process verification program from CSL Behring is presented, showing trend data from recent cleaning validations. The conclusion emphasizes that cleaning validation presents challenges, but robust processes supported by scientific rationale are expected by regulators to control contamination.
The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
This document discusses cleaning validation requirements from a regulatory perspective. It provides an overview of key concepts in cleaning validation including establishing health-based exposure limits and determining maximum allowable carryover levels. A risk-based approach using bracketing and worst-case determination is recommended. Common deficiencies observed include inadequate hazard assessment, lack of justification for cleaning approaches, and failure to revalidate cleaning when processes change. International GMPs are incorporating guidelines for setting health-based exposure limits to ensure contamination risks are properly managed.
this presentation contains information about HACCP implementation in food industry. with example, easy to understand comment below how is this presentation
The document discusses several topics related to quality assurance of drugs, including emerging trends, key recommendations, tasks for corporate quality assurance units, communication strategies, validation variations, product integrity, managing suppliers and third parties, hazard analysis and critical control points (HACCP), guidelines for applying HACCP, and good automated manufacturing practices (GAMP). Some of the main points discussed are the changing quality assurance environment and need for continuous improvement, effective communication across the organization, risk-based auditing, ensuring product validation is continuously updated, and employing quality control and validation strategies according to ICH standards.
This document outlines the steps for cleaning validation in a GMP pharmaceutical manufacturing plant. It discusses establishing cleaning procedures and validation programs to ensure no carryover of active ingredients between products. Key steps include: identifying equipment to validate, selecting worst-case products, calculating acceptance limits for rinse and swab samples based on product toxicity, and conducting analytical method validation including rinse and swab recovery studies. The purpose is to demonstrate cleaning processes consistently remove residues to acceptable levels between product batches.
This document discusses risk analysis and HACCP systems. It defines risk as a function of the probability and severity of adverse health effects from hazards in food. It outlines the components of risk analysis: risk assessment, risk management, and risk communication. It then details the steps of risk assessment and describes how risk assessment should consider relevant practices throughout the food chain. It also discusses risk management, risk communication, and provides a diagram of the risk analysis process. Finally, it outlines the principles and benefits of implementing a HACCP system.
Contamination Control Cleaning Validation.pdfHassanHani5
This presentation discusses cleaning validation, including potential contaminants, regulatory requirements, challenges, and continuous process verification programs. It outlines the scope of a cleaning validation program, including validation plans, sampling strategies, and continued process verification. An example continuous process verification program from CSL Behring is presented, showing trend data from recent cleaning validations. The conclusion emphasizes that cleaning validation presents challenges, but robust processes supported by scientific rationale are expected by regulators to control contamination.
HACCP stands for Hazard Analysis Critical Control Point which is important and preliminary step used for ensuring safety of food before it reaches to consumers
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that involves identifying and controlling biological, chemical, and physical hazards. It includes conducting a hazard analysis, identifying critical control points, establishing critical limits, and implementing ongoing monitoring, corrective actions, and record keeping procedures. Prerequisite programs like facilities and equipment sanitation, supplier control, and employee hygiene must also be established as the foundation for an effective HACCP system. Implementing HACCP in India's food industry, especially the unorganized sector, faces challenges including lack of resources, infrastructure, and stakeholder coordination.
Freshtz Products is a pineapple jam manufacturing plant located in Sri Lanka that was established in 2000. It currently employs 400 people and produces jam to serve the local market. The company wants to implement an HACCP plan to assure product safety and expand its market share. It receives raw materials from qualified suppliers and follows Good Manufacturing Practices and sanitation procedures. The document provides an overview of HACCP and outlines the 8 forms needed to develop an HACCP plan for pineapple jam, including forms for product description, ingredients, hazard analysis, determining critical control points, establishing critical limits, and verification. It also describes the preliminary steps of assembling an HACCP team and documenting product details.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
Hazard Analysis and Critical Control Point (HACCP) is a process control system designed to identify and prevent food safety hazards. It involves a systematic approach to identify hazards, assess risks, and implement controls at critical points in food production. The seven HACCP principles guide food businesses to conduct a hazard analysis, identify critical control points, establish critical limits, monitor controls, validate the system is working, and maintain records. HACCP was developed in the 1960s and its implementation has expanded globally over the past 50 years through regulations and standards to improve food safety.
The document outlines the principles of Hazard Analysis and Critical Control Points (HACCP). It begins with definitions of key HACCP terms and concepts. It then describes the seven principles of HACCP, which include conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and documentation. The document also provides details on carrying out a HACCP study through 14 stages and includes examples of using a decision tree to determine critical control points.
HACCP Training Material VER 002 05.05.15.pptxDeparted Moon
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP) for an in-house training course. It defines HACCP and explains that it is a systematic approach to identify, evaluate, and control food safety hazards. The document outlines the 7 principles of HACCP, including conducting a hazard analysis, determining critical control points, establishing critical limits, and implementing monitoring, corrective action, and verification procedures. It also discusses prerequisite programs that must be in place before implementing HACCP.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP), a systematic approach for identifying and controlling hazards. It describes the 7 core principles of HACCP: conducting a hazard analysis, determining critical control points, establishing target levels and critical limits, monitoring critical control points, establishing corrective actions, verifying the HACCP system is working, and documenting procedures. The document then discusses preliminary tasks for applying HACCP, including defining the risk question and scope, assembling a multidisciplinary team, describing the product/process, and conducting a hazard analysis to identify potential hazards at each process step.
The HACCP system is a preventative system that identifies and controls potential hazards in food production. It was developed in the 1960s for the US space program to prevent microbial growth and contamination. Codex Alimentarius later refined it for international use in food safety management systems. The HACCP system can be applied in any facility that handles food, from production to consumption, as it systematically identifies and monitors potential risks and establishes procedures to control them.
The HACCP system is a preventative system that identifies and controls potential hazards in food production. It was developed in the 1960s for the US space program to prevent microbial growth and contamination. Codex Alimentarius later refined it for international use in food safety management systems. The HACCP system can be applied in any facility that handles food, from production to consumption, as it systematically identifies and monitors potential risks and establishes procedures to control them.
This document discusses the Hazard Analysis and Critical Control Point (HACCP) system for ensuring food safety. It defines HACCP and explains its seven principles for identifying and controlling food safety hazards. The document also outlines the steps to implement a HACCP program in a food processing plant, including forming a HACCP team, conducting a hazard analysis and identifying critical control points, establishing monitoring procedures, and verifying that the HACCP system is working properly. The goal of HACCP is to prevent food safety hazards through control at critical points during food production rather than relying on end product inspection.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
This document discusses cleaning validation for pharmaceutical manufacturing. It defines validation as providing evidence that a process will consistently produce expected results. Regulations require validating cleaning procedures to confirm effectiveness and reduce residues to acceptable levels. The objective of cleaning validation is to establish reliable cleaning procedures to minimize analytical monitoring. Key principles discussed include establishing a cleaning standard operating procedure considering cleansing agents, equipment, and documentation. Products are grouped based on solubility, potency, and formulation risk factors. Worst case scenarios can be selected either product-specific or equipment-specific.
This document provides an overview of risk analysis as it relates to food safety. It defines risk as a function of hazard probability and severity. Risk analysis includes risk assessment, management, and communication. Risk assessment involves hazard identification, characterization, exposure assessment, and risk characterization. The document outlines the steps of a risk assessment and notes that risk management involves weighing policy alternatives based on risk assessment results. It also provides details on Hazard Analysis and Critical Control Points (HACCP), a food safety system that identifies, evaluates, and controls hazards through establishment of critical control points and limits.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
Food Safety: Validation, Sampling/Lotting, and EventsComecarne
This document discusses validation and verification procedures for Hazard Analysis and Critical Control Point (HACCP) plans. It provides definitions and guidelines for validation from regulatory sources to establish that a HACCP plan is functioning properly. Validation involves collecting scientific and technical information to determine if the HACCP plan will effectively control hazards when implemented. Verification activities ensure the HACCP plan is being followed correctly. The document outlines approaches for initial validation and ongoing verification including in-plant observations, measurements, and microbiological testing. It emphasizes using various tools to prove ongoing process control rather than relying solely on end-product testing.
1) This document discusses Statistical Process Control (SPC), which uses statistical methods to monitor and control processes to ensure they operate at full potential. SPC aims to maximize conforming product output while minimizing waste.
2) Key aspects of SPC include understanding variation in processes, distinguishing between common and special causes of variation, using statistical tools like control charts to monitor processes and detect issues, and taking action to control processes and continually improve quality.
3) The document outlines the basic elements of a process control system, including gathering performance information, taking action on processes and outputs, and using feedback to maintain stability and reduce variation. It emphasizes prevention over detection to avoid waste.
Cleaning validation for the 21 th century pharmaceutical onlineEmma Aguinaga
This eBook is a collection of articles written from May of 2017 through August 2018 and are part of the cleaning validation for the "Cleaning Validation for teh 21 st Century" series.
Hello guys,
Welcome to my profile.
Practice School Report
Yh practice school report B.Pharm ke 7th semester me bnayi jati hi, jo bhi aap school training me sikhte ho wahi sb is report me mention krna hota hai.
#bpharmacy
#careerinpharmacy
#bpharmanotes
#bpharmacynotes
#careerinpharmacyfield
#bpharmacy
#bpharm
#careerinpharma
#bpharmacylectures
#handwrittennotes
#pharmalectures
#akkuvibes
8.4 PERFORMANCE QUALIFICATION PROTOCOL FOR DISPENSING BOOTH (1).pdfabdo badr
The document provides a performance qualification protocol for a dispensing booth supplied by Pharma Engineers in Hyderabad, India. It outlines five tests to be conducted: 1) filter integrity, 2) air velocity, 3) airflow visualization, 4) particle counting, and 5) certification of results. The objective is to qualify and certify the performance of the dispensing booth according to specifications. Key details provided include equipment dimensions, test methods, acceptance criteria, and test result tables.
The document discusses three proposals:
1. The first proposal is for 8 people to share airline tickets.
2. The second proposal suggests 4 people share half of the airline tickets.
3. The third proposal discusses sending staff from Hansella Bearing to Germany and Portugal, including the total number of staff and tickets that would be provided.
The proposals aim to save on accommodation costs for 3 people over 2 weeks due to current economic conditions.
More Related Content
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HACCP stands for Hazard Analysis Critical Control Point which is important and preliminary step used for ensuring safety of food before it reaches to consumers
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that involves identifying and controlling biological, chemical, and physical hazards. It includes conducting a hazard analysis, identifying critical control points, establishing critical limits, and implementing ongoing monitoring, corrective actions, and record keeping procedures. Prerequisite programs like facilities and equipment sanitation, supplier control, and employee hygiene must also be established as the foundation for an effective HACCP system. Implementing HACCP in India's food industry, especially the unorganized sector, faces challenges including lack of resources, infrastructure, and stakeholder coordination.
Freshtz Products is a pineapple jam manufacturing plant located in Sri Lanka that was established in 2000. It currently employs 400 people and produces jam to serve the local market. The company wants to implement an HACCP plan to assure product safety and expand its market share. It receives raw materials from qualified suppliers and follows Good Manufacturing Practices and sanitation procedures. The document provides an overview of HACCP and outlines the 8 forms needed to develop an HACCP plan for pineapple jam, including forms for product description, ingredients, hazard analysis, determining critical control points, establishing critical limits, and verification. It also describes the preliminary steps of assembling an HACCP team and documenting product details.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
Hazard Analysis and Critical Control Point (HACCP) is a process control system designed to identify and prevent food safety hazards. It involves a systematic approach to identify hazards, assess risks, and implement controls at critical points in food production. The seven HACCP principles guide food businesses to conduct a hazard analysis, identify critical control points, establish critical limits, monitor controls, validate the system is working, and maintain records. HACCP was developed in the 1960s and its implementation has expanded globally over the past 50 years through regulations and standards to improve food safety.
The document outlines the principles of Hazard Analysis and Critical Control Points (HACCP). It begins with definitions of key HACCP terms and concepts. It then describes the seven principles of HACCP, which include conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and documentation. The document also provides details on carrying out a HACCP study through 14 stages and includes examples of using a decision tree to determine critical control points.
HACCP Training Material VER 002 05.05.15.pptxDeparted Moon
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP) for an in-house training course. It defines HACCP and explains that it is a systematic approach to identify, evaluate, and control food safety hazards. The document outlines the 7 principles of HACCP, including conducting a hazard analysis, determining critical control points, establishing critical limits, and implementing monitoring, corrective action, and verification procedures. It also discusses prerequisite programs that must be in place before implementing HACCP.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP), a systematic approach for identifying and controlling hazards. It describes the 7 core principles of HACCP: conducting a hazard analysis, determining critical control points, establishing target levels and critical limits, monitoring critical control points, establishing corrective actions, verifying the HACCP system is working, and documenting procedures. The document then discusses preliminary tasks for applying HACCP, including defining the risk question and scope, assembling a multidisciplinary team, describing the product/process, and conducting a hazard analysis to identify potential hazards at each process step.
The HACCP system is a preventative system that identifies and controls potential hazards in food production. It was developed in the 1960s for the US space program to prevent microbial growth and contamination. Codex Alimentarius later refined it for international use in food safety management systems. The HACCP system can be applied in any facility that handles food, from production to consumption, as it systematically identifies and monitors potential risks and establishes procedures to control them.
The HACCP system is a preventative system that identifies and controls potential hazards in food production. It was developed in the 1960s for the US space program to prevent microbial growth and contamination. Codex Alimentarius later refined it for international use in food safety management systems. The HACCP system can be applied in any facility that handles food, from production to consumption, as it systematically identifies and monitors potential risks and establishes procedures to control them.
This document discusses the Hazard Analysis and Critical Control Point (HACCP) system for ensuring food safety. It defines HACCP and explains its seven principles for identifying and controlling food safety hazards. The document also outlines the steps to implement a HACCP program in a food processing plant, including forming a HACCP team, conducting a hazard analysis and identifying critical control points, establishing monitoring procedures, and verifying that the HACCP system is working properly. The goal of HACCP is to prevent food safety hazards through control at critical points during food production rather than relying on end product inspection.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
This document discusses cleaning validation for pharmaceutical manufacturing. It defines validation as providing evidence that a process will consistently produce expected results. Regulations require validating cleaning procedures to confirm effectiveness and reduce residues to acceptable levels. The objective of cleaning validation is to establish reliable cleaning procedures to minimize analytical monitoring. Key principles discussed include establishing a cleaning standard operating procedure considering cleansing agents, equipment, and documentation. Products are grouped based on solubility, potency, and formulation risk factors. Worst case scenarios can be selected either product-specific or equipment-specific.
This document provides an overview of risk analysis as it relates to food safety. It defines risk as a function of hazard probability and severity. Risk analysis includes risk assessment, management, and communication. Risk assessment involves hazard identification, characterization, exposure assessment, and risk characterization. The document outlines the steps of a risk assessment and notes that risk management involves weighing policy alternatives based on risk assessment results. It also provides details on Hazard Analysis and Critical Control Points (HACCP), a food safety system that identifies, evaluates, and controls hazards through establishment of critical control points and limits.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
Food Safety: Validation, Sampling/Lotting, and EventsComecarne
This document discusses validation and verification procedures for Hazard Analysis and Critical Control Point (HACCP) plans. It provides definitions and guidelines for validation from regulatory sources to establish that a HACCP plan is functioning properly. Validation involves collecting scientific and technical information to determine if the HACCP plan will effectively control hazards when implemented. Verification activities ensure the HACCP plan is being followed correctly. The document outlines approaches for initial validation and ongoing verification including in-plant observations, measurements, and microbiological testing. It emphasizes using various tools to prove ongoing process control rather than relying solely on end-product testing.
1) This document discusses Statistical Process Control (SPC), which uses statistical methods to monitor and control processes to ensure they operate at full potential. SPC aims to maximize conforming product output while minimizing waste.
2) Key aspects of SPC include understanding variation in processes, distinguishing between common and special causes of variation, using statistical tools like control charts to monitor processes and detect issues, and taking action to control processes and continually improve quality.
3) The document outlines the basic elements of a process control system, including gathering performance information, taking action on processes and outputs, and using feedback to maintain stability and reduce variation. It emphasizes prevention over detection to avoid waste.
Cleaning validation for the 21 th century pharmaceutical onlineEmma Aguinaga
This eBook is a collection of articles written from May of 2017 through August 2018 and are part of the cleaning validation for the "Cleaning Validation for teh 21 st Century" series.
Hello guys,
Welcome to my profile.
Practice School Report
Yh practice school report B.Pharm ke 7th semester me bnayi jati hi, jo bhi aap school training me sikhte ho wahi sb is report me mention krna hota hai.
#bpharmacy
#careerinpharmacy
#bpharmanotes
#bpharmacynotes
#careerinpharmacyfield
#bpharmacy
#bpharm
#careerinpharma
#bpharmacylectures
#handwrittennotes
#pharmalectures
#akkuvibes
Similar to 04_ISPEs_Guides_and_How_They_Apply_to_Cleaning_and_Cleaning_Validation_by_Stephanie_Wilkins.pdf (20)
8.4 PERFORMANCE QUALIFICATION PROTOCOL FOR DISPENSING BOOTH (1).pdfabdo badr
The document provides a performance qualification protocol for a dispensing booth supplied by Pharma Engineers in Hyderabad, India. It outlines five tests to be conducted: 1) filter integrity, 2) air velocity, 3) airflow visualization, 4) particle counting, and 5) certification of results. The objective is to qualify and certify the performance of the dispensing booth according to specifications. Key details provided include equipment dimensions, test methods, acceptance criteria, and test result tables.
The document discusses three proposals:
1. The first proposal is for 8 people to share airline tickets.
2. The second proposal suggests 4 people share half of the airline tickets.
3. The third proposal discusses sending staff from Hansella Bearing to Germany and Portugal, including the total number of staff and tickets that would be provided.
The proposals aim to save on accommodation costs for 3 people over 2 weeks due to current economic conditions.
This document outlines Sun Pharmaceutical Industries Limited's Enterprise Risk Management policy. It defines key aspects of the company's ERM framework, including the following:
1. It establishes an ERM framework in accordance with international risk management standards to proactively manage risks across the company.
2. Key components of the framework include risk identification, assessment, treatment, monitoring, and accountability. Risk owners are responsible for managing risks in their areas.
3. The policy defines roles for the board, risk management committee, internal audit team, function heads, risk coordinators, and risk owners in implementing and maintaining the ERM system.
4. Risk appetite statements define thresholds for financial impacts and qualitative parameters to guide
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The document discusses various aspects of cleaning validation including selecting a cleaning method, establishing acceptance criteria, selecting worst case scenarios for equipment and products, determining storage periods, and sampling methods. It provides details on calculating maximum allowable residue limits based on therapeutic doses and batch sizes. For their facilities, the company selected a manual cleaning method and swab sampling due to product diversity, validation of automated equipment, and trained staff. Contamination limits are below 10 ppm or based on visual detection of 4 micrograms per square centimeter.
This document discusses filling capsules and blisters with powder for inhalation. It describes various dosing systems like dosators, vacuum drums, and membrane fillers. Dosators are a flexible and established technology but can have issues like sticking and limited accuracy. Vacuum drums and membrane fillers allow for more precise microdosing of low amounts down to 0.5mg. 100% in-line verification of dosed mass is desirable for quality and avoids underfilled units from issues like bridging. A capacitive VisioAMV sensor allows real-time mass verification during the filling process for process control. Machine integration can scale these systems from development to high-speed commercial production.
The document provides details on developing a validation master plan, including definitions of key terms like validation, qualification, and protocols. It discusses the importance and types of validation as well as the key elements, format, and content of a validation master plan. The content includes facilities, equipment, utilities, processes to be validated, responsibilities, schedules, documentation requirements, and protocols for qualification stages.
The document discusses the history and development of chocolate over centuries. It details how chocolate originated from cacao beans in South and Central America that were used as currency by early civilizations like the Mayans and Aztecs. The Spanish introduced chocolate to Europe in the 16th century, where it became popular as a drink among the elite. Chocolate production methods were refined over the following centuries to create chocolate candy and other products that are widely enjoyed around the world today.
This document contains a list of 178 tasks related to fire alarm, fire fighting, smoke and ventilation systems for 17 buildings. It includes the task name, duration, required manpower, and start and end dates for each task. The tasks involve installing conduits, cables, panels, detectors, pipes, sprinklers, and other equipment and components. Testing and commissioning is included for each system.
1) The document discusses validation of water systems for pharmaceutical use, including water quality specifications, purification methods, and commissioning, qualification, operation and maintenance of the systems.
2) It outlines various water grades including drinking water, purified water, highly purified water, and water for injections, and describes methods for producing each grade including distillation, ion exchange, ultrafiltration and reverse osmosis.
3) Validation of water systems aims to demonstrate the capability of the systems to consistently supply water meeting predetermined quality criteria through qualification testing over extended periods and under varying conditions.
This document describes the development and validation of an HPLC method for the simultaneous determination of impurities and degradation products in Cardiazol. The method utilizes gradient elution on a C18 column with UV detection at 240nm. The method was validated according to ICH guidelines and found to be specific, sensitive, linear, precise and accurate for quantifying two known impurities (Impurities A and B) and unknown degradation products. The method can also distinguish Cardiazol from degradation products formed under various stress conditions like acid/base hydrolysis and oxidation.
Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
Communicating effectively and consistently with students can help them feel at ease during their learning experience and provide the instructor with a communication trail to track the course's progress. This workshop will take you through constructing an engaging course container to facilitate effective communication.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
1. ISPE’S GUIDES AND HOW
THEY APPLY TO
CLEANING AND CLEANING
VALIDATION
Stephanie A. Wilkins, PE
ISPE NORDIC
CLEANING VALIDATION CONFERENCE
20 April 2016
2. ispe.org
Connecting Pharmaceutical Knowledge
> ISPE’s Risk-MaPP Guide and its impact on cleaning
– What is Risk-MaPP?
– Health-based limits and cleaning
– Revision 2 Updates with respect to cleaning
> ISPE’s Cleaning Guide Status
– Baseline® Guide Status
– Good Practice Guide Status
Objectives
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Risk-MaPP* provides a
scientific risk-based
approach, based on ICH Q9,
to manage the risk of cross
contamination in order to
achieve and maintain
an appropriate balance
between product quality and
operator safety.
4
Risk- MaPP
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ADE
A dose that is unlikely to cause an
adverse effect if an individual is
exposed, by any route, at or below
this dose every day for a lifetime.
By definition the ADE is protective
of all populations by all routes of
administration.
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Risk-MaPP
Introduces Health-Based Limits
ADE (mg/day) = NOAEL (mg/kg/day) * BW (kg)
Ufc * MF * PK
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Risk-MaPP
Why Health-Based Limits Matter
Acceptance Limit (based on ADE)
Data
Margin of
Safety
New Limit determined by adding
additional safety factors
Apparent Margin of Safety
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> In many instances current cleaning programs including cleaning
validation may be adequate when transitioning to health-based limits.
– Compare current 1/1000th, 10 ppm, or other to the ADE or PDE value
» If the ADE or PDE value is greater than the current value,
cleaning and cleaning validation can adequately meet the
health-based limit.
• This is the case with many products.
» If the ADE or PDE value is lower than the current value,
then the cleaning program and cleaning validation need to
be reviewed to confirm adequacy.
Risk-MaPP
Transitioning to Health-Based LImits
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> Introducing a new product into the facility
– Cleaning process development prior to entry into facility.
» If not possible a robust risk assessment that considers all
available historical information and cleaning performance
data to assess the risk from the cleaning process.
» Verification of the cleaning should also be performed after
each campaign of the new product introduced when
cleaning development activities are not able to be
completed.
– Analytical methods must be sensitive enough to detect the residue
limits.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> Inactivation of API during Cleaning and Sterilization
– The ADE methodology is based on the assumption that the product is
active after cleaning and sterilization.
– If the API degrades into pharmacologically inactive fragments, the
acceptance limit for the process residue should be set based on the
inactive fragments instead of the active ingredient.
– This requires studies to determine if the product can effectively be
degraded and denatured into inactive fragments.
– To determine the effectiveness of the degrading and denaturing
process the ADE is necessary to ensure that the API is not present in
unsafe levels after degrading/ denaturing.
– If residual API is found after the degrading/denaturing process, the
acceptance limit should be determined based on the ADE value of
the API.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> Why not use the lowest of all methodologies to set the limits?
– The health-based limit represents a level that is safe for all patient
populations and reducing this further does not increase patient safety
– Actually lowers the apparent margin-of-safety. Lower than necessary
cleaning acceptance limits increase the risk of a cleaning failure.
> It is expected that companies will have robust cleaning processes that
provide as large a safety margin as possible especially where existing
data indicates the ability to clean to very low residue levels.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> Cleaning validation in the product lifecycle
> Following completion and approval of cleaning validation runs, a risk-
based program of ongoing monitoring should be established to assure
the cleaning process remains consistent and effective.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> Statistical measures of cleaning process capability should be utilized
where they are both feasible and meaningful.
– It is possible, but not likely, that there will be sufficient data generated
during Process Design (or “stage 1”) of a new product/new cleaning
process to assess process capability prior to validation and routine
use.
– More commonly however, there is insufficient or inadequate pre-
validation cleaning data so as to be useful in constructing the science
and data based case for cleaning procedure efficacy.
– In most situations, “real-world” shop-floor data must be collected and
analyzed for this purpose. The collection, analysis and reporting of
cleaning process output data is the function and purpose of the two
subsequent lifecycle stages.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> It is important that the residue data is as far below the health-based
residue level as possible. Comparing these data to the residue level
derived from the ADE provides a measure of the “True Margin of Safety”
for the cleaning process.
> If risks are high (where the residue data is near or above the health-
based residue level), then additional measures, such as improving the
cleaning procedure and/or increasing monitoring frequency, should be
pursued and documented.
> If risks cannot be reduced to acceptable levels or are considered too
difficult to implement, then the equipment being cleaned should be
either dedicated or made disposable.
Risk-MaPP Revisions
Updates to Cleaning Aspects
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> The introduction of new products may be significantly accelerated by
using existing data IF such data captures both performance of the
cleaning process developed and the understood nature of any residuals
to be removed.
– Evaluate against the existing worst-case product(s) for acceptable
residual limits and “cleanability”. If new product is new worst case,
cleaning validation is necessary, otherwise may not need cleaning
validation.
– Caution must be used in interpreting pass/fail results for existing
(validated) procedures as quantitative and objective indications of the
capability of any new, “similar” procedures.
– Only actual data is data.
– If suitable analytical results for existing cleaning procedures are not
available, new ones must be generated to determine acceptability.
Risk-MaPP Revisions
New Product Introduction
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> It is not necessary to simulate the entire cleaning process at small
scale; instead, it is sufficient to simulate the worst-case location from
the standpoint of cleanability. If the process residue can be adequately
removed from the worst-case location, it follows that it can also be
adequately removed from other locations in the equipment.
> Another important consideration in the development of experimental
models for evaluating cleanability is to determine the worst-case
mechanism or means of cleaning.
– For clean-in-place systems, the worst-case mechanism of cleaning is
typically through diffusion-controlled mass transfer in a gravity-
induced falling film
– For manual processes the worst-case means of cleaning is
determined by physical limitations associated with manually cleaning
the worst-case location
Risk-MaPP Revisions
Cleanability at Small Scale
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> Unlike analytical sampling and testing, visual inspection can and must
be done (to whatever degree possible) with every cleaning process
execution.
> Prior to initiation of manufacturing of the subsequent batch, equipment
is routinely inspected for visual cleanliness by manufacturing personnel
and documented in the manufacturing batch record.
> Any failure of the visual inspection is also recorded so that a true
assessment of the cleaning program can be made.
> Establish visual detection levels of residues generally visible to
operating personnel, given the site-specific variables such as
equipment configurations and light conditions on the shop floor
Risk-MaPP Revisions
Visual Inspection
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> Base on science and risk-based understanding of the hazards and
cleaning agents
> Use Quality unit preapproved protocols containing sampling sites,
methods and rationale for selection, details of cleaning procedure, and
both visual and analytical criteria for acceptance
> Include multiple test repetitions to demonstrate consistency and
reproducibility
– There is no current expectation to formally justify the number of
validation runs, that is, a three-run cleaning validation is still typical
and generally acceptable. T
– Science and process knowledge should always be the first
consideration, and an evaluation of run-to-run variability should still
be a factor to determine the actual number of runs required to provide
sufficient assurance prior to commercial use of a new cleaning
procedure.
Risk-MaPP Revisions
Cleaning Validation Program
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> Monitor post-validation in a justified and effective manner to assure
ongoing cleaning procedure effectiveness.
– “Stage 3” or continued process verification (CPV) monitoring for a
validated cleaning process can include analytical and/or visual
components, applied in a risk-based manner that is dependent on
very specific and contextual aspects of a given product and its
cleaning processes.
– On-line TOC to directly measure (or correlate with) residual levels
– Swab or rinse of “worst-case” monitoring locations, a risk assessment
informed by the cleaning validation run results can aid in determining
the most challenging and failure-indicating sample locations
– In cases where the acceptance limits are well above visual detection
and the cleaning process is robust, analytical sampling may be
reduced as justified by risk assessments.
Risk-MaPP Revisions
Continued Process Verification for Validated Cleaning
Processes
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> When health-based residual limits are at or below the limits of visual
detection, visual inspection is of only indirect value in determining an
absence of active ingredient residue
> A qualification criterion for visual inspection of cleaned equipment by
personnel should be considered.
> Following the precepts of ICH Q9, the level of effort and formality should
be commensurate with the patient risk, and therefore the degree of
formality around a visual inspection qualification program is best
established by site and product specific risk assessment.
Risk-MaPP Revisions
Visual Inspection
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> Where the method of detection is visual only
– it is important to understand the visual acuity of the staff and what
level of residue is considered safe.
– If the safe level is below the visual acuity of the staff then the risk of
failure not being detected may be considered high whereas if the
safe level is well above (several orders of magnitude) the visual
acuity of the staff the risk of failure not being detected may be
considered low.
> The degree of variability in product contact equipment cleaning
processes should be understood and considered as a primary factor in
ongoing monitoring decisions.
– As an example, automated CIP processes present less risk from a
variability perspective than manual cleaning methods, and may
therefore justify less ongoing monitoring (once mechanical reliability
is proven) than a manual process.
Risk-MaPP Revisions
Dectability
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> The Guide was a spin off from the Risk-MaPP Baseline® Guide to more
adequately address the cleaning aspects of pharmaceutical equipment.
– The guide’s focus was on science, statistical and risk-based
approaches – a future state - not the current baseline for GMP
compliance
> Baseline® Guides generally include regulatory review prior to
publication
– The Cleaning Baseline® Guide only received input by one regulator
– The input from one regulator was not considered adequate to support
use of the category. There has been a substantial discord on the
need for this further review, and especially in regard to making
subsequent amendments to the guide content.
>
Cleaning Baseline® Guide Status
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> In the spring of 2015, ISPE’s Guidance Documents Committee (GDC)
requested an additional SME review to ensure that the scope of the
Cleaning Validation Baseline® Guide draft was appropriate in parallel
with a review by regulators, in order to allow use of the “Baseline”
document category.
> The guide content was originally maintained on the ASTM website, with
whom ISPE had an amicable agreement regarding shared copyright.
– The situation regarding the existing writing team became significantly
more complex with their unauthorized and unprecedented
copywriting of the text.
> Because of this lack of clarity and confirmation of the “Baseline® Guide”
standard of the Guide content, ISPE has decided not to further develop
or to publish the existing Cleaning Validation Baseline® Guide draft.
Cleaning Baseline® Guide Status
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> ISPE has stated its ownership of well-known marks such as trademarks,
logos and repeatedly offered its disposition to resolve the matter.
– However these overtures have been met with the current writing
team’s unwillingness to consider any changes to the text and its
ownership thereof.
> In its place and with a view to providing a work of knowledge that adds
value to the entire ISPE community, ISPE is planning a new Guide on
cleaning.
Cleaning Baseline® Guide Status
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> ISPE is forming a team to develop a Good Practice Guide on Cleaning.
– A Good Practice Guide (GPG) focuses on the “how to”
– A Baseline® Guide focuses on the “what needs to be done”
> Current status
– Co-leads on board
» Joseph Payne, QA, Alcami formerly AAI Pharma
» Rob Walker, GMP Consultancy Ltd
– GDC mentors on board
» Nick Haycock, Amgen
» Stephanie Wilkins, PharmaConsult Us
Cleaning Guide Status
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> How will this guide be different to the myriad of others available?
– Provide specific “how to” advice
– For example some guides state:
» “operators should be qualified for visual inspection”
• This guide will provide information on issues to consider
and methods to qualify operators for visual inspection
» “use risk assessment or risk management techniques”
• This guide will provide practice advice on what to
consider when assessing and managing risk as well as
some examples
Cleaning Guide Status
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> This document would provide a single source of information, in respect
of how to clean and the validation of different cleaning practices
> For who? Regulations associated with cleaning and validation; Different
types of cleaning; acceptance criteria, Sterile dosage forms; oral solid
dose, biotech, APIs, Analytical techniques?
Cleaning Guide Status
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> Tentative topics to be included:
– Regulations and applications to cleaning and cleaning validation
– Cleaning methodologies
– Equipment issues and challenges
– Dedicated equipment and campaign manufacture issues
– Sampling techniques and locations
– Acceptance criteria
– Examples of assay methods and validation
– Change Control and impact on Validation status
Cleaning Guide Status
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