This procedure have been established to prevent mix-ups of Empty container, component, labels, documents and mistakes while preparing or processing a product during the time of job change.
Line clearance is a procedure to ensure equipment and work areas are free from materials from previous processes and ready for the next process. It involves clearing equipment of previous materials, cleaning, and checking. The purpose is to prevent mix-ups, contamination, and cross-contamination between products and batches. Proper line clearance, cleaning, separation of lines, and changeover approval are important cGMP requirements.
This document outlines procedures for clearing and cleaning production lines before changing products to prevent mix-ups. It details:
- Removing all materials from the previous product, including documents. Supervisors ensure the area is cleared.
- Cleaning the area thoroughly once cleared. Two types of cleaning are described: batch-to-batch and product-to-product.
- Filling clearance documents and having QA personnel inspect and sign off before giving line clearance to proceed with the next product. Temperature, humidity and cleaning standards must be met.
Line clearance is an important procedure to prevent mix-ups and mistakes during manufacturing. It involves three stages: clearing, cleaning, and checking. During clearing, materials from the previous production are removed. Next, cleaning is done according to standard operating procedures. Finally, the line is checked and any issues are recorded before clearance is given to begin the next production. Line clearance must be performed before various stages of production such as dispensing, filling, packaging, and more. It helps ensure safety and quality in manufacturing.
This document provides guidelines for effective area and line clearance procedures during production changeovers to ensure patient and customer safety. It defines key terms and outlines control measures for reject materials, equipment design considerations, documentation requirements, and investigation of line clearance failures. The purpose is to minimize risks from foreign materials contaminating product batches during changeovers.
Distribution, Electronic data handling and controlled documentation by Khushb...KhushbooKunkulol
This document discusses documentation, distribution, and electronic data handling procedures for pharmaceutical companies. It contains the following key points:
1. Documentation procedures ensure standardized and unambiguous procedures are followed to minimize errors. Distribution records must allow for efficient product recall if needed.
2. Electronic data handling uses computers to collect, store, and analyze data. It generates audit trails and records for activities like batch production. The ALCOA principles provide guidelines for ensuring electronic data is attributable, legible, contemporaneous, original, and accurate.
3. Controlled documents are subject to versioning and access restrictions to ensure only the correct version is used. Uncontrolled documents are not versioned and can be freely edited for reference purposes.
Qualification of tablet compression machinePritam Kolge
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
Line clearance is a procedure to ensure equipment and work areas are free from materials from previous processes and ready for the next process. It involves clearing equipment of previous materials, cleaning, and checking. The purpose is to prevent mix-ups, contamination, and cross-contamination between products and batches. Proper line clearance, cleaning, separation of lines, and changeover approval are important cGMP requirements.
This document outlines procedures for clearing and cleaning production lines before changing products to prevent mix-ups. It details:
- Removing all materials from the previous product, including documents. Supervisors ensure the area is cleared.
- Cleaning the area thoroughly once cleared. Two types of cleaning are described: batch-to-batch and product-to-product.
- Filling clearance documents and having QA personnel inspect and sign off before giving line clearance to proceed with the next product. Temperature, humidity and cleaning standards must be met.
Line clearance is an important procedure to prevent mix-ups and mistakes during manufacturing. It involves three stages: clearing, cleaning, and checking. During clearing, materials from the previous production are removed. Next, cleaning is done according to standard operating procedures. Finally, the line is checked and any issues are recorded before clearance is given to begin the next production. Line clearance must be performed before various stages of production such as dispensing, filling, packaging, and more. It helps ensure safety and quality in manufacturing.
This document provides guidelines for effective area and line clearance procedures during production changeovers to ensure patient and customer safety. It defines key terms and outlines control measures for reject materials, equipment design considerations, documentation requirements, and investigation of line clearance failures. The purpose is to minimize risks from foreign materials contaminating product batches during changeovers.
Distribution, Electronic data handling and controlled documentation by Khushb...KhushbooKunkulol
This document discusses documentation, distribution, and electronic data handling procedures for pharmaceutical companies. It contains the following key points:
1. Documentation procedures ensure standardized and unambiguous procedures are followed to minimize errors. Distribution records must allow for efficient product recall if needed.
2. Electronic data handling uses computers to collect, store, and analyze data. It generates audit trails and records for activities like batch production. The ALCOA principles provide guidelines for ensuring electronic data is attributable, legible, contemporaneous, original, and accurate.
3. Controlled documents are subject to versioning and access restrictions to ensure only the correct version is used. Uncontrolled documents are not versioned and can be freely edited for reference purposes.
Qualification of tablet compression machinePritam Kolge
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
Quality assurance maintenance of hvac system in pharmaceutical industryShahbazNadaf
The document discusses quality assurance maintenance of HVAC systems. It describes the importance of regularly maintaining HVAC systems to ensure consistent performance and longevity. Key aspects of HVAC maintenance include inspecting and changing air filters, cleaning debris, checking refrigerant levels, and lubricating moving parts. The document provides tips for maintenance schedules and lists 30 points to check during maintenance.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning is important because particulate contamination is invisible. Operators must be trained in proper gowning procedures to prevent introducing contamination. Gowning involves several steps like showering, removing jewelry at home and at work, and putting on attire like coveralls, booties and gloves in the correct order when moving between areas of different cleanroom classes. Maintaining clean attire and routes is important for minimizing contamination risks.
Good documentation practices are essential for GMP compliance and quality assurance. Documentation provides traceability for all development, manufacturing, and testing activities, and allows auditors to assess quality. Documents must be accurate, complete, clear, reliable, legible, retrievable, permanent, and current. They include records, specifications, batch records, logbooks, and standard operating procedures. All documentation must be properly maintained and controlled.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
Good Manufacturing Practices.
Basic rules of GMP
Various aspects of GMP.
How do GMP change.
Comparison of GMP.
Quality assurance
Principles of QA
Functions of QA department.
Documentation
Importance of documentation of records
Important areas of documentation
Components of documentation
Auditing of capsule, sterile production and packaging MittalRohit2
The document discusses vendor audits, supplier audits, and audits of sterile product manufacturing facilities. It provides information on:
- The purpose of vendor and supplier audits to assess compliance and reduce costs.
- Key areas evaluated in vendor audits like management responsibility and data integrity.
- Benefits of audits like cost savings, process improvements, and risk reduction.
- Elements of a supplier audit checklist like infrastructure, traceability, and regulatory compliance.
- Additional controls needed for sterile product manufacturing like clean rooms, air filtration, and environmental monitoring.
- Areas examined in audits of sterile facilities including equipment validation, personnel training, and media fill programs.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
The document discusses aseptic processing and sterile manufacturing. It defines aseptic processing as bringing together sterilized product, container, and closure under controlled conditions to prevent contamination. Key elements of aseptic processing include personnel, facility, equipment, and process. The document also outlines various quality control tests performed during manufacturing like appearance, pH, sterility, and drug content tests. It discusses facility design considerations for aseptic areas including utility locations, engineering areas, and maintenance facilities.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
The document discusses the validation of HVAC systems in pharmaceutical facilities. It describes how HVAC systems are integral to maintaining suitable temperature, airflow, and preventing contamination. The validation of HVAC systems involves tests of air flow patterns, velocity, filtration, particles counts, temperature and humidity controls. Specific tests are outlined, including air flow testing using smoke, filter leak testing, viable particle monitoring, and recovery testing temperature and humidity levels. The methodology describes how each of these tests are performed to validate that the HVAC system is functioning properly and as intended.
Good Warehousing Practices (GWH) in Pharmaceutical IndustrySwapnil Karale
Mr. Swapnil Karale has over 10 years of experience in the pharmaceutical industry and is qualified as a cGMP auditor. He has expertise in quality assurance, auditing, validation, calibration and training. The presentation covers good warehousing practices, including premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt and storage of goods, packing for transportation, and transportation. Maintaining proper documentation of all warehousing activities is emphasized.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
The document discusses auditing of sterile production processes. It outlines several key areas that an auditor must evaluate, including building and facilities, HVAC systems, environmental monitoring, garments, sanitation, equipment, manufacturing processes, sterilization, and documentation. The auditor needs to ensure control measures are in place to prevent contamination and assess if critical environmental parameters and cleaning/sanitization procedures are properly followed. The manufacturing records also must contain all relevant processing details to ensure sterility of batches. Auditing is important to verify sterile production meets Good Manufacturing Practice standards.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Top management shall regularly review the organization's quality management system to ensure its continuing suitability, adequacy, and effectiveness. This review analyzes opportunities for improvement and considers changes needed to policies and objectives. Records of management reviews are maintained.
The inputs to management review include information on audits, customer feedback, process and product performance, corrective actions, previous review follow-ups, system changes, and recommendations for improvement.
The outputs from management review include decisions and actions related to improving system and process effectiveness, product quality regarding customer requirements, and resource needs.
This document discusses in-process quality control. It defines quality and describes the in-process quality control process which includes understanding production parameters, creating control plans, monitoring parameters, reporting results, identifying defects, providing feedback, and correcting issues. It describes different types of in-process inspections and factors affecting inspections. The "4M's" of inspection - machine, method, material, and man - are also discussed as well as final inspections, sampling plans, quality control in distribution, acceptance quality limits, common defect types, and the importance of quality control.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
Quality assurance maintenance of hvac system in pharmaceutical industryShahbazNadaf
The document discusses quality assurance maintenance of HVAC systems. It describes the importance of regularly maintaining HVAC systems to ensure consistent performance and longevity. Key aspects of HVAC maintenance include inspecting and changing air filters, cleaning debris, checking refrigerant levels, and lubricating moving parts. The document provides tips for maintenance schedules and lists 30 points to check during maintenance.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning is important because particulate contamination is invisible. Operators must be trained in proper gowning procedures to prevent introducing contamination. Gowning involves several steps like showering, removing jewelry at home and at work, and putting on attire like coveralls, booties and gloves in the correct order when moving between areas of different cleanroom classes. Maintaining clean attire and routes is important for minimizing contamination risks.
Good documentation practices are essential for GMP compliance and quality assurance. Documentation provides traceability for all development, manufacturing, and testing activities, and allows auditors to assess quality. Documents must be accurate, complete, clear, reliable, legible, retrievable, permanent, and current. They include records, specifications, batch records, logbooks, and standard operating procedures. All documentation must be properly maintained and controlled.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
Good Manufacturing Practices.
Basic rules of GMP
Various aspects of GMP.
How do GMP change.
Comparison of GMP.
Quality assurance
Principles of QA
Functions of QA department.
Documentation
Importance of documentation of records
Important areas of documentation
Components of documentation
Auditing of capsule, sterile production and packaging MittalRohit2
The document discusses vendor audits, supplier audits, and audits of sterile product manufacturing facilities. It provides information on:
- The purpose of vendor and supplier audits to assess compliance and reduce costs.
- Key areas evaluated in vendor audits like management responsibility and data integrity.
- Benefits of audits like cost savings, process improvements, and risk reduction.
- Elements of a supplier audit checklist like infrastructure, traceability, and regulatory compliance.
- Additional controls needed for sterile product manufacturing like clean rooms, air filtration, and environmental monitoring.
- Areas examined in audits of sterile facilities including equipment validation, personnel training, and media fill programs.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
The document discusses aseptic processing and sterile manufacturing. It defines aseptic processing as bringing together sterilized product, container, and closure under controlled conditions to prevent contamination. Key elements of aseptic processing include personnel, facility, equipment, and process. The document also outlines various quality control tests performed during manufacturing like appearance, pH, sterility, and drug content tests. It discusses facility design considerations for aseptic areas including utility locations, engineering areas, and maintenance facilities.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
The document discusses the validation of HVAC systems in pharmaceutical facilities. It describes how HVAC systems are integral to maintaining suitable temperature, airflow, and preventing contamination. The validation of HVAC systems involves tests of air flow patterns, velocity, filtration, particles counts, temperature and humidity controls. Specific tests are outlined, including air flow testing using smoke, filter leak testing, viable particle monitoring, and recovery testing temperature and humidity levels. The methodology describes how each of these tests are performed to validate that the HVAC system is functioning properly and as intended.
Good Warehousing Practices (GWH) in Pharmaceutical IndustrySwapnil Karale
Mr. Swapnil Karale has over 10 years of experience in the pharmaceutical industry and is qualified as a cGMP auditor. He has expertise in quality assurance, auditing, validation, calibration and training. The presentation covers good warehousing practices, including premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt and storage of goods, packing for transportation, and transportation. Maintaining proper documentation of all warehousing activities is emphasized.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
The document discusses auditing of sterile production processes. It outlines several key areas that an auditor must evaluate, including building and facilities, HVAC systems, environmental monitoring, garments, sanitation, equipment, manufacturing processes, sterilization, and documentation. The auditor needs to ensure control measures are in place to prevent contamination and assess if critical environmental parameters and cleaning/sanitization procedures are properly followed. The manufacturing records also must contain all relevant processing details to ensure sterility of batches. Auditing is important to verify sterile production meets Good Manufacturing Practice standards.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Top management shall regularly review the organization's quality management system to ensure its continuing suitability, adequacy, and effectiveness. This review analyzes opportunities for improvement and considers changes needed to policies and objectives. Records of management reviews are maintained.
The inputs to management review include information on audits, customer feedback, process and product performance, corrective actions, previous review follow-ups, system changes, and recommendations for improvement.
The outputs from management review include decisions and actions related to improving system and process effectiveness, product quality regarding customer requirements, and resource needs.
This document discusses in-process quality control. It defines quality and describes the in-process quality control process which includes understanding production parameters, creating control plans, monitoring parameters, reporting results, identifying defects, providing feedback, and correcting issues. It describes different types of in-process inspections and factors affecting inspections. The "4M's" of inspection - machine, method, material, and man - are also discussed as well as final inspections, sampling plans, quality control in distribution, acceptance quality limits, common defect types, and the importance of quality control.
The document summarizes efforts to reduce downtime of the Starmatic Labeler on the Liquid Salad Dressing Line. It outlines that the labeler experienced over 10,000 minutes of downtime in 2011, accounting for 30.7% of total unplanned downtime. The project objective is to decrease labeler downtime by 50% by March 2012 through optimizing preventative maintenance. Key focus areas include preventative maintenance, cleaning/inspection, training, equipment repairs, changeovers, and label materials. The team implemented improved lubrication, inspection, and cleaning procedures as well as operator training and accountability measures. Over 60 worn parts were replaced on the labeler. Future work involves cultural changes to create a cleaner and more efficient
IAP.pdf INSPECTION, ASSEMBLY AND PACKAGING (IAP)Talal Albudayri
Inspection, Assembly and Packaging (IAP)
Zone
After cleaning and disinfection, reusable
medical devices are received in the
Inspection, Assembly and Packaging zone
to prepare for sterilization. Reusable
medical devices are now safe for handling
and extra care must be taken to ensure
that they are not re-contaminated. Strict
hand hygiene must be maintained and
personal protective equipment must be
used at all times.
This document provides an overview of 5S training. The 5S system involves five steps - Sort, Set in Order, Shine, Standardize, and Sustain - for organizing and cleaning a workplace. It discusses the benefits of 5S including improved safety, quality and efficiency. Key aspects of implementing each 5S step are described such as identifying unnecessary items in Sort, optimizing storage locations in Set in Order, establishing cleaning standards in Shine, and visual management techniques for Standardize. Sustaining 5S requires ongoing communication to ensure standards are followed. The overview explains how 5S creates a more productive work environment through visual controls and waste elimination.
This document discusses changeover clearance, which is a process to ensure an area is free of residue before a new process. It describes minor changeovers between batches of the same product and major changeovers between different products. The types of changeovers and responsible personnel are defined. Key aspects of changeover clearance include cleaning equipment and areas, ensuring correct documentation, and labeling. Changeover clearance helps prevent mix-ups and contamination between products to maintain quality. The document stresses the importance of proper changeover clearance procedures.
The document provides guidelines for production and validation processes. It discusses ensuring production is performed according to defined procedures and good manufacturing practices to obtain quality products. Materials must be checked upon receipt and quarantined until approved. Equipment and areas must be cleaned between products to prevent cross-contamination. Deviations from procedures require approval. Validation includes qualification of equipment, processes, cleaning, and change control to ensure reproducibility and compliance.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
The document provides information on maintaining training facilities and equipment. It includes schedules and checklists for maintaining different areas of the training facility as well as equipment. Key details include plans for maintaining workshop areas, operational procedures for equipment like desktop computers, importance of maintenance programs and schedules, and sample inspection checklists for facilities and equipment.
The document provides information on maintaining training facilities and equipment. It includes schedules and checklists for maintaining different areas of the training facility as well as equipment. Key details include plans for maintaining workshop areas, operational procedures for equipment like desktop computers, importance of maintenance programs and schedules, and sample inspection checklists for facilities and equipment.
This document discusses the control of nonconforming products. It emphasizes clearly identifying nonconforming products using consistent tags (e.g. red, yellow, green bins). Nonconforming products must be prevented from unintended use through containment, which includes segregating products and using a containment worksheet to identify all suspect products. Leadership must develop a system to control nonconforming products, and all containment activities must be approved by the customer.
Ambulance Bay Project - Conference PosterDon Sharpe
Multiple departments at AHS are working together to improve an ambulance bay that was previously in an unacceptable state. Staff who were previously resigned to the poor conditions of the workspace have become engaged as improvements are being realized. New systems and solutions from other industries are being integrated and unique practices are being developed and implemented in the ambulance bay that have not been seen before in the hospital industry.
Pilot plant scaleup techniques used in pharmaceutical manufacturingSunil Boreddy Rx
The document discusses pilot plant scale-up techniques. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. The objectives of pilot plant studies are to examine a formula's ability to withstand scale-up, identify critical process aspects, and provide manufacturing guidelines to avoid problems. Key considerations for pilot plants include personnel requirements, equipment selection, production rates, process evaluation, and product stability testing.
Chinna Praveen Kumar is a Terminal Operator with over 5 years of experience in oil and gas operations. He currently works for HPCL Mittal Energy Ltd. in Bathinda, India, where his responsibilities include operating equipment like pumps, meters, tanks, and pipelines to receive, store, blend, and dispatch crude oil and refined products. He also assists with the commissioning of new facilities and equipment. Previously, he worked for Hi Tech Carbon managing carbon black feedstock storage and handling operations.
The document provides information on implementing the 5S methodology. It includes:
1. An overview of the 5S implementation process which involves sorting, setting in order, shining, standardizing, and self-discipline.
2. Details on the "shine" element which involves adopting cleaning as a daily activity and inspecting defined areas.
3. Examples of ways to prevent dirty floors like using oil collection mats and locating waste oil tanks outside work areas.
4. Actions needed to standardize processes like developing visual controls and assigning responsibilities.
5. The importance of self-discipline which includes recognizing 5S achievements to create good habits.
Manufacturing setup startup after lockdown thought by dhananjaydhananjayDVGune
The document provides guidance for safely restarting factory operations after a lockdown. It outlines procedures that must be followed across various departments, including adhering to government guidelines, ensuring employee safety, reviewing work-in-progress, checking equipment and supplies, and communicating with stakeholders. Departments covered include office, HR, purchasing, stores, receiving inspection, production planning, foundry, heat treatment, machine shop, final inspection, packing, and development. The goal is to safely restart operations while addressing any backlogs or issues that arose during the lockdown period.
Quality Assurance Services, Inc. provides quality assurance services including receiving inspection, containment, sorting, inspection, rework, repair, and warehousing for customers. Its mission is to be a successful supplier committed to continuous improvement, customer satisfaction, employee development, long-term partnerships, growth and profitability. It aims to be the industry leader in quality services through strategic partnerships. The company orients its processes around customer requirements and satisfaction through effective inspection, containment of non-conforming products, and meeting production schedules.
Similar to Line clearence by Phani venkata sai ram (20)
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Org Design is a core skill to be mastered by management for any successful org change.
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3. This procedure have
been established to
prevent mix-ups of
Empty container,
component, labels,
documents and mistakes
while preparing or
processing a product
during the time of job
change.
4. 3 STAGES OF LINE
CLEARANCE
CLEARING
CLEANING
CHECKING
5.
6. To Do:
- Remove all the previous job related items
from area/line like bottles, tools, mold
components, machine parts, plugs, left over
solution/material, product, labels , printed
cartons, batch coding, packed products,
documents.
Responsibility:
-Q. Inspectors / D. supervisors to make sure all
the previous jobs related products, documents,
etc., are placed in their location. & all waste is
disposed properly.
-Supervisors to cross check whether it is
followed properly and report the same to Team
leader’s/Department heads/Managers.
7.
8. To Do:
-Clean area/line up to the maximum possible
extent
-Cleaning to be done only after CLEARING
Responsibility:
-Q. Inspectors / D. Supervisors responsibility
for cleaning.
-Supervisors & Team leaders responsibility to
make sure sufficient arrangement like
manpower and resources are arranged to clean
the line
9.
10. To Do:
-Check & Fill the Line clearance form.
-Checking to be carried out only after clearing
and cleaning of previous products.
-1 person from each department (D&P and
Q.A) has to cross check the area / line. The
same should be recorded in the Line clearance
form.
-Area / line clearance failure should be
recorded in the same line clearance form
after stopping/closing the line, and informed
to immediate Team leaders.
Responsibility:
-Line/Area Supervisor ensure the clearing and
cleaning.
11. Line clearance, Line cleaning and Line checking
(Decoration & Packing area)
Line: Shift: Date:
Job name: Last bottle of previous
job at Low rater time:
First bottle of
new job at Low rater time:
Decoration operator (A): QA Inspector (B):
S.no Check list A
YES/NO
B
YES/NO
1 Check whether decoration machine job setup card is available for the new job.
2 Check if low rater grippers are clean and free from foreign particles.
3 Check if whether there is any direct metal contact to bottles from low rater to
decoration lehr entrance.
4 Check if decoration machine area is free dust and previous bottles.
5 Check if in feed and out feed conveyors of decoration machine are dust and oil
free.
6 Check if counters are set properly to Zero and adjusted as per bottle height.
7 Check if decoration lehr set point temperature is kept as per the validated setup.
8 Check if the art work of the new job is attached near the visual screen.
9 Check if whether the art work of the previous job is removed for the display board
near the visual screen.
10 Check if whether all the documents of the previous job are replaced with the new
one.
11 Check if whether Label/Tag is attached to the incomplete pallets of the previous
job and/are cleared for sending to the Quarantine area.
12 Check if Inspection table, single liners and complete area of line is free from
previous bottles and foreign particles.
13 Check if the visual screen is cleaned and free form the dust.
14 Check if whether there is any jerking of single liners and any bottle falling
problem for the previous job is cleared.
15 Check if the depallatiser is free from dust and any direct metal contact to the
bottles.
16 Check if bottom light is in working condition.
17 Check if pallet packing specification is place in the packing area.
18 Check if the packing area is clean & free from the previous bottles and foreign
particles.
Prepared by Reviewed by Approved by
D&P Operator D&P Supervisor D&P Team leader/D&P HOD.
QA Inspector QA Supervisor QC Team Leader/QA Manager.
12. Area/line clearance
failure:-
Critical line clearance failure
must be subjected to issue a
Corrective action request
(CAR) against the
Person/Department and to be
investigated to identify the root
cause.
13.
14. Control of rejection:-
- Rejected item should be kept in
separate pallet with identification
tag.
- Online rejected items should be
kept in pallets with status label or
send directly to re-processing/re-
cycling area.
15. - Line clearance to be carried
out prior to
commencement of same
product different batch
(same job artwork/Label
change) or different
product (Job change).
- If the line is not used
immediately after cleaning and
clearing it must be
rechecked immediately
NOTE:
17. - Live line clearance has been successfully used as a
useful training tool for new operators or for the
introduction of new equipment. It involves the placing
of ‘dummy’ articles with in the area / line after the
checking is completed.
- Operators are then asked to find the dummies.
If all of the dummies are not found then this may
indicate the need for further operator training or
modification to the procedures or checklist.
- The dummies should be placed in areas where
clearing or checking are known to be a problem.
- The dummies used should not be capable of being
confused for the genuine article. Defaced genuine
articles should not be used as dummies.
- Dummies used should not be capable of being
packaged or further processed. An example of an
acceptable dummy is a colored plastic, magnetic etc.,
18. - Also, with frequency based on
reasonable level of confidence or
at least twice in a year all Q.A in
process personnel will be
evaluated for line clearance
activity effectiveness.
- Q.A and Concerned
Departments personnel shall be
given training for line clearance
activity and evaluated for the
effectiveness.
Training frequency &
Responsibility
REFERENCE:-
ISO 15378: 2006
WWW.FDA.GOV.COM