This document is a checklist for auditing general controls and compliance with cGMP regulations at a pharmaceutical manufacturing facility. It contains over 100 questions organized into sections related to organizational responsibilities, documentation, training programs, facility controls, equipment controls, and calibration programs. The checklist verifies that the facility has appropriate quality systems, documentation, and controls in place to ensure the manufacturing and testing of drug products meets cGMP requirements.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document provides an overview of OHSAS 18001, an internationally applied British Standard for occupational health and safety management systems. It defines OHSAS 18001, describes its development and specifications, and outlines the key requirements for an organization to implement an occupational health and safety management system according to the standard. This includes developing an OH&S policy, identifying hazards and risks, implementing controls, training employees, conducting audits and management reviews, and maintaining certification of the system. The goal of the standard is to help organizations control occupational health and safety risks.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
The document discusses quality audit checklists and their benefits. It explains that checklists help auditors sample key elements of a quality management system in a logical, unbiased way. Checklists also keep the audit focused and reduce workload. The document then provides guidance on creating checklists for adequacy audits to evaluate whether documentation addresses all standard requirements and ensures policy and objective achievement.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document provides an overview of OHSAS 18001, an internationally applied British Standard for occupational health and safety management systems. It defines OHSAS 18001, describes its development and specifications, and outlines the key requirements for an organization to implement an occupational health and safety management system according to the standard. This includes developing an OH&S policy, identifying hazards and risks, implementing controls, training employees, conducting audits and management reviews, and maintaining certification of the system. The goal of the standard is to help organizations control occupational health and safety risks.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
GAMP 5 provides guidance for computerized systems validation. It focuses on risk-based approaches and scalability of efforts based on a system's risk, complexity, and novelty. GAMP 5 also emphasizes leveraging supplier activities and avoiding duplication of efforts. The document provides a framework for life cycle activities from concept to retirement, including planning, specification, development, operation, and retirement of computerized systems.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
The document discusses quality audit checklists and their benefits. It explains that checklists help auditors sample key elements of a quality management system in a logical, unbiased way. Checklists also keep the audit focused and reduce workload. The document then provides guidance on creating checklists for adequacy audits to evaluate whether documentation addresses all standard requirements and ensures policy and objective achievement.
This document discusses a six system inspection model for quality management in pharmaceutical manufacturing. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it outlines the key aspects and cites the relevant cGMP regulations. It emphasizes that the six systems are interrelated and must work together to ensure quality control and compliance with regulations. Regular self-inspections are also highlighted as an important part of pharmaceutical quality management.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
This document discusses the importance of good documentation practices in the pharmaceutical industry. It defines documentation and outlines the types used, including documents, records, guidelines and policies. Good documentation ensures traceability and compliance. Key aspects include legible, accurate writing and signatures with dates. Changes must be clearly indicated without obscuring original records. Good documentation benefits include quality assurance, compliance and training.
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.
This document provides an overview of validation including:
1. The history and importance of validation in ensuring consistent quality production. Validation became a regulatory requirement after issues with sterility and product quality in the 1960s-1970s.
2. The scope of validation includes facilities, equipment, analytical methods, processes, cleaning, and personnel.
3. Key validation types are prospective, concurrent, retrospective, and revalidation which is required when changes are made.
4. A validation master plan outlines the entire validation program and assigns responsibilities. It provides a comprehensive guide for validation activities.
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
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.
This document discusses quality auditing. It defines auditing and quality auditing, outlines quality auditing standards and types of audits. It describes audit activities like planning, information gathering, communication, drafting the audit report, and getting management response. The document explains roles of client, auditor and auditee in audits and the audit process from notification to feedback. It provides guidance on managing an audit program according to ISO 19011.
This document introduces an auditor checklist and self-assessment tool for the BRCGS Global Standard Food Safety, Issue 9. It explains how to use the tool to assess compliance with the standard and prepare for a certification audit. While useful for preparation, the tool alone is not considered an internal audit. Training resources and contact information are provided for any additional questions.
This document is an audit checklist for conducting an ISO 9001:2008 audit and gap analysis. It contains over 50 questions addressing the requirements of ISO 9001:2008's clauses for quality management systems. The checklist identifies conformance levels of yes, no, opportunity for improvement, minor nonconformance, and major nonconformance. It also includes spaces for audit evidence and references. The checklist will be used to audit an organization's quality management system against the ISO 9001:2008 standard.
This document discusses a six system inspection model for quality management in pharmaceutical manufacturing. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it outlines the key aspects and cites the relevant cGMP regulations. It emphasizes that the six systems are interrelated and must work together to ensure quality control and compliance with regulations. Regular self-inspections are also highlighted as an important part of pharmaceutical quality management.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
This document discusses the importance of good documentation practices in the pharmaceutical industry. It defines documentation and outlines the types used, including documents, records, guidelines and policies. Good documentation ensures traceability and compliance. Key aspects include legible, accurate writing and signatures with dates. Changes must be clearly indicated without obscuring original records. Good documentation benefits include quality assurance, compliance and training.
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.
This document provides an overview of validation including:
1. The history and importance of validation in ensuring consistent quality production. Validation became a regulatory requirement after issues with sterility and product quality in the 1960s-1970s.
2. The scope of validation includes facilities, equipment, analytical methods, processes, cleaning, and personnel.
3. Key validation types are prospective, concurrent, retrospective, and revalidation which is required when changes are made.
4. A validation master plan outlines the entire validation program and assigns responsibilities. It provides a comprehensive guide for validation activities.
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
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.
This document discusses quality auditing. It defines auditing and quality auditing, outlines quality auditing standards and types of audits. It describes audit activities like planning, information gathering, communication, drafting the audit report, and getting management response. The document explains roles of client, auditor and auditee in audits and the audit process from notification to feedback. It provides guidance on managing an audit program according to ISO 19011.
This document introduces an auditor checklist and self-assessment tool for the BRCGS Global Standard Food Safety, Issue 9. It explains how to use the tool to assess compliance with the standard and prepare for a certification audit. While useful for preparation, the tool alone is not considered an internal audit. Training resources and contact information are provided for any additional questions.
This document is an audit checklist for conducting an ISO 9001:2008 audit and gap analysis. It contains over 50 questions addressing the requirements of ISO 9001:2008's clauses for quality management systems. The checklist identifies conformance levels of yes, no, opportunity for improvement, minor nonconformance, and major nonconformance. It also includes spaces for audit evidence and references. The checklist will be used to audit an organization's quality management system against the ISO 9001:2008 standard.
This document provides an overview of validation requirements in the pharmaceutical industry. It begins with definitions of validation from FDA guidelines in 1987 and 2011. Validation originated in the 1970s focused on sterilization, and has now expanded to all product, process, and facility matters. Validation is required to assure quality, is a regulatory requirement, and reduces costs. The stages of validation for a product and process are outlined, including process design, process qualification, and continuous process verification. Key aspects of validation like process validation, change control, and documentation are also summarized.
This document is an auditor checklist and site self-assessment tool for the BRC Global Standard for Food Safety. It contains requirements for senior management commitment and food safety plans incorporating Hazard Analysis and Critical Control Points (HACCP) principles. The checklist covers topics such as the food safety team and developing food safety plans, identifying hazards and critical control points, establishing monitoring procedures, and corrective actions. It provides a tool for auditors and sites to assess conformance with the BRC Global Standard.
The Quality Unit plays an important role in GMP maintenance according to regulations. The Quality Unit must approve preventative maintenance procedures and any changes to ensure equipment remains validated and products are of appropriate quality. Regulations require maintenance procedures describing methods, schedules, and responsibilities to be established and approved by the Quality Unit. While maintenance departments have technical expertise, Quality Unit review is still required to ensure compliance.
The document provides a checklist for auditing Good Manufacturing Practices (GMP) at pharmaceutical manufacturing facilities. It covers over 20 sections including quality assurance, premises, personnel, validation, documentation, vendor qualification, change control, sampling, stability studies, drug recall, audits, quality control departments, and specific manufacturing areas. The checklist contains over 300 criteria to evaluate facilities and ensure compliance with GMP standards.
This document is a factory evaluation corrective action plan that contains information about a factory audit. It includes the factory name and address, audit dates and evaluators. It summarizes the audit scores in various categories related to quality management, production control, supplier management, and more. For each low scoring area, it lists corrective actions that need to be taken, including the person responsible and implementation date. The document is intended to outline the improvements needed based on the audit findings.
This document is an audit checklist for ISO 15378:2011 quality management systems. It contains over 100 questions to evaluate an organization's compliance with the requirements of the ISO 15378 standard, which provides additional requirements for quality management systems in the pharmaceutical packaging industry. The checklist covers topics like documentation, management responsibility, resource management, and more. Auditors are to evaluate each requirement and document whether it is fulfilled, partially fulfilled, or not fulfilled.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptxShankar Maind Patil
This Slideshare Contain a Brief information about the How Auditing Of QA Department is considered and followed in the Industry to get . Desired Quality product throughout the all production step and in the batch .
Objective importance and Advantages of QA Auditing are explained here. In this slide for giving out and detailed study About it .
The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
This document provides guidance on process validation for medical device manufacturers. It discusses the purpose and scope of process validation, definitions of key terms, and when processes should be validated versus verified. It describes the three phases of validation: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Guidelines are provided for developing validation protocols, conducting validations, and maintaining validated states. Statistical tools that can be used in validation are also summarized. The overall intent is to help manufacturers understand quality system requirements and apply principles of process validation.
Sop 820 capa procedure corrective preventive action med devConnie Dello Buono
This document outlines the corrective and preventive action (CAPA) procedure for addressing non-conformances and quality problems. It defines when a CAPA should be initiated, such as for systemic or repetitive issues. It describes assigning a CAPA owner to investigate the root cause and identify corrective actions. Effectiveness of these actions must be verified through follow-up audits. Preventive actions may also be initiated through trend analysis to address potential problems. All CAPAs require management review and sign-off for implementation and closure within 4 months. The CAPA coordinator communicates results and actions to management.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
1) Prospective process validation requires a planned program from early development stages and utilizes information generated throughout development to validate the final production process.
2) Key aspects of the validation program include experimental design, documentation, defining objectives and variables, and maintaining effective organization and communication among team members.
3) The validation is supported by a master documentation file containing all information needed to set up the validated production process.
Hiranandani Hospital in Powai, Mumbai, is a premier healthcare institution that has been serving the community with exceptional medical care since its establishment. As a part of the renowned Hiranandani Group, the hospital is committed to delivering world-class healthcare services across a wide range of specialties, including kidney transplantation. With its state-of-the-art facilities, advanced medical technology, and a team of highly skilled healthcare professionals, Hiranandani Hospital has earned a reputation as a trusted name in the healthcare industry. The hospital's patient-centric approach, coupled with its focus on innovation and excellence, ensures that patients receive the highest standard of care in a compassionate and supportive environment.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
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1. GM P AUDIT CHECKLIST
Page 1 of 11
1.0 General Controls
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.0.1 Does the facility and its many departments (organizational units) operate in a state of control as defined
by the GMP regulations?
1.1 Organizational & M anagement Responsibilities
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.1.1 Does this facility/business unit operate under a facility or corporate quality policy?
1.1.2 §211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity?
1.1.3 §211.22(a) Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all
components, drug product containers and closures, in-process materials, packaging materials, labeling
and drug products?
1.1.4 §211.22 Does the QA department or unit routinely review production records to ensure that procedures were
followed and properly documented?
1.1.5 §211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing?
1.1.6 If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the
contractor's site and verified that the laboratory space, equipment, qualified personnel and procedures
are adequate?
1.1.7 Date of last inspection:
1.1.8 §211.22(c) Are all QA procedures in writing?
1.1.9 §211.22(c) Are all QA responsibilities in writing?
1.1.10 Are all written QA procedures current and approved? (Review log of procedures)
1.1.11 Are the procedures followed? (Examine records to ensure consistent recordkeeping that adequately
documents testing.)
1.1.12 §211.25 Are QA supervisory personnel qualified by way of training and experience?
1.1.13 §211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and
experience?
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1.2 Documentation
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.2.1 §211.22(a) Does the QA unit have a person or department specifically charged with the responsibility of
designing, revising, and obtaining approval for production and testing procedures, forms, and
records?
1.2.2 §211.22(d) Does a written SOP exist for each record or form identifying how the form is to be completed and
who signs and countersigns,?
1.2.3 §211.165(a
)(b)(c)
Are the production batch record and release test results reviewed for accuracy and completeness
before a batch/lot of finished product is released?
1.3 Employee Orientation, Quality Awareness, and Job Training
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.3.1 Does this facility/business unit operate under a facility or corporate quality policy?
1.3.2 Circle the types of orientation provided to each new employee:
(1) Company brochure
(2) Literature describing GMP regulations and stressing importance of following instructions.
(3) On-the-job training for each function to be performed (before the employee is allowed to perform such
tasks).
(4) Other: (write in)
1.3.3 §211.25(a) Does each employee receive retraining on an SOP (procedures) if
critical changes have been made in the procedure?
1.3.4 Indicate how on-going, periodic GMP training is accomplished:
(write in)
1.3.5 §211.25 Is all training documented in writing that indicates the following:
• date of training
• type of training
• signatures of both the employee and the trainer?
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1.3.6 §211.25 Are training records readily retrievable? Do records indicate what training a specific employee has
received, and which employees have been trained on a particular procedure, or have attended a
particular training program?
1.3.7 Are GMP trainers qualified through experience and training?
1.3.8 §211.25(a) Are supervisory personnel instructed to prohibit any employee that may adversely affect the safety or
quality of drug products* from coming into direct contact with any drug component or containers for
finished product?
*Any physical condition as determined by medical examination or supervisory observation.
1.3.9 §211.28(d) Are employees required to report to supervisory personnel any health or physical condition that may have
an adverse effect on drug product safety and purity?
1.3.10 §211.25(a) Are temporary employees given the same orientation as permanent employees?
1.3.11 §211.34 Are consultants who are hired to advise on any aspect of manufacture, processing, packing or holding, or
approval for release of drug products, asked to provide evidence of their education, training, and
experience?
1.3.12 §211.34 Are written records maintained for consultants stating:
• name
• address
• qualifications
• date of service
• type of service provided?
1.4 Plant Safety and Security
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.4.1 Does this facility have a facility or corporate safety program?
1.4.2 Are safety procedures written?
1.4.3 Are safety procedures current?
1.4.4 Do employees receive safety orientation before working in the plant area?
1.4.5 Is safety training documented in a readily retrievable manner that states the name of the employee, the
type of training, the date of the training, and the name of the trainer and the signature of the trainer and
the participant?
1.4.6 Does this facility have a formal, written security policy?
1.4.7 Is access to the facility restricted?
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1.4.8 Describe how entry is monitored/restricted:
1.4.9 Is a security person available 24 hours per day?
1.5 Internal Quality/GM P Audit Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.5.1 Does this business unit/facility have a written quality policy?
1.5.2 Is a copy of this quality policy furnished to all employees?
1.5.3 If "yes" to above, when is it provided?
1.5.4 Is training provided in quality improvement?
1.5.5 Does a formal auditing function exist in the Quality Assurance department?
1.5.6 Does a written SOP specify the qualifications (education, training, and experience) of those who conduct
audits?
1.5.7 Does a written SOP specify the scope and frequency of audits and how such audits are to be
documented?
1.5.8 Does a written SOP specify the distribution of the audit report?
1.6 Quality Cost Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
1.6.1 Does this facility have a periodic and formal review of the cost of quality?
1.6.2 Does this facility have the ability, through personnel, software, and accounting records, to identify and
capture quality costs?
1.6.3 Does this facility make a conscious effort to reduce quality costs?
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2.0 Design Control
Not directly related to 21 CFR Parts 210 and 211
3.0 Facility Control
3.1 Facility Design and Layout
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
3.1.1 §211.42(a) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing,
and holding of drug products?
3.1.2 §211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production?
3.1.3 Does the layout and organization of the facility prevent contamination?
3.2 Environmental Control Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
3.2.1 The facility is NOT situated in a location that potentially subjects workers or product to particulate matter,
fumes, or infestations?
3.2.2 Are grounds free of standing water?
3.2.3 §211.44 Is lighting adequate in all areas?
3.2.4 §211.46 Is adequate ventilation provided?
3.2.5 §211.46 Is control of air pressure, dust, humidity, and temperature adequate for the manufacture, processing,
storage or testing of drug products?
3.2.6 §211.46 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?
3.2.7 Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility?
3.2.8 §211.42(d) Does the facility have separate air handling systems, if required, to prevent contamination?
NOTE: THIS IS MANDATORY IF PENICILLIN IS PRESENT!
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3.3 Facility M aintenance and Good Housekeeping Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
3.3.1 §211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin?
3.3.2 §211.56(c) Does this facility have written procedures for the safe use of suitable, (i.e., those that are properly
registered) rodenticides, insecticides, fungicides, and fumigating agents?
3.3.3 Is this facility maintained in a clean and sanitary condition?
3.3.4 Does this facility have written procedures that describe in sufficient detail the cleaning schedule,
methods, equipment and material?
3.3.5 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents?
3.3.6 §211.58 Are all parts of the facility maintained in a good state of repair?
3.3.7 §211.52 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient
frequency?)
3.4 Outside Contractor Control Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
3.4.1 §211.56(d) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing,
and holding of drug products?
3.4.2 Are contractors qualified by experience or training to perform tasks that may influence the production,
packaging, or holding of drug products?
4.0 Equipment Control
4.1 Equipment Design and Placement
Question
Number
GM P Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
4.1.1 §211.63 Is all equipment used to manufacture, process or hold a drug product the appropriate design and size
for its intended use?
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4.1.2 Are the following pieces of equipment suitable for their purpose?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.3 Are the following pieces of equipment suitable in their size/capacity?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.4 Are the following pieces of equipment suitable in their design?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.5 Are the locations in the facility of the following pieces of equipment acceptable?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.6 Are the following pieces of equipment properly installed?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.7 Is there adequate space for the following pieces of equipment?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
4.1.8 §211.65(a) Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-
additive so as not to affect the product?
4.1.9 §211.65(b) Are design and operating precautions taken to ensure that lubricants or coolants or other operating
substances do NOT come into contact with drug components or finished product?
4.1.10 §211.72 Fiber-releasing filters are NOT used in the production of injectable products?
4.1.11 §211.72 Asbestos filters are NOT used in the production of products?
4.1.12 Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"?
4.1.13 Is equipment cleaned promptly after use?
4.1.14 Is idle equipment stored in a designated area?
4.1.15 §211.67(a)(b) Are written procedures available for each piece of equipment used in the manufacturing, processing
or holding of components, in-process material, or finished product?
4.1.16 Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no
cleaning solution or rinse remains in the equipment?
4.1.17 Does the cleaning procedure or startup procedure ensure that the equipment is systematically and
thoroughly cleaned?
4.2 Equipment Identification
Question
Number
GM P Section
Number if
Applicable
Question or Instruction Yes, No, or NA
4.2.1 §211.105 Are all pieces of equipment clearly identified with easily visible markings?
4.2.2 §211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an
entry in an equipment log?
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4.2.3 Does each piece of equipment have written instructions for maintenance that includes a schedule
for maintenance?
4.2.4 Is the maintenance log for each piece of equipment kept on or near the equipment?
4.3 Equipment M aintenance & Cleaning
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction Yes, No, or NA
4.3.1 §211.67(b) Are written procedures established for the cleaning and maintenance of equipment and utensils?
4.3.2 Are these procedures followed?
4.3.3 §211.67(b)(
1)
Does a written procedure assign responsibility for the cleaning and maintenance of equipment?
4.3.4 §211.67(b)(
2)
Has a written schedule been established and is it followed for the maintenance and cleaning of
equipment?
4.3.5 Has the cleaning procedure been properly validated?
4.3.6 §211.67(b)(
2)
If appropriate, is the equipment sanitized using a procedure written for this task?
4.3.7 §211.67(b)(
3)
Has a sufficiently detailed cleaning and maintenance procedure been written for each different
piece of equipment to identify any necessary disassembly and reassembly required to provide
cleaning and maintenance?
4.3.8 §211.67(b)(
3)
Does the procedure specify the removal or obliteration of production batch information from each
piece of equipment during its cleaning?
4.3.9 Is equipment cleaned promptly after use?
4.3.10 Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment?
4.3.11 §211.67(b)(
5)
Is clean equipment adequately protected against contamination prior to use?
4.3.12 §211.67(b) Is equipment inspected immediately prior to use?
4.3.13 §211.67(c) Are written records maintained on equipment cleaning, sanitizing and maintenance on or near
each piece of equipment?
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4.4 M easurement Equipment Calibration Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction Yes, No, or NA
4.4.1 §211.68(a) Does the facility have approved written procedures for checking and calibration of each piece of
measurement equipment?
(Verify procedure and log for each piece of equipment and note exceptions.)
4.4.2 §211.68(a) Are records of calibration checks and inspections maintained in a readily retrievable manner?
4.5 M easurement Equipment Calibration Program
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction Yes, No, or NA
4.5.1 §211.63 Verify that all pieces of equipment used in production, packaging, and quality assurance are
capable of producing valid results.
4.5.2 §211.68(a) When computers are used to automate production or quality testing, have the computer and
software been validated?
4.5.3 Have on-site tests of successive production runs or tests been used to qualify equipment?
4.5.4 Were tests repeated a sufficient number of times to ensure reliable results?
4.5.5 §211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and
maximum operating speeds for valid results?
4.5.6 Have performance characteristics been identified for each piece of equipment? (May be provided
by the manufacturer, but must be verified under typical operations conditions.)
4.5.7 Have operating limits and tolerances for performance been established from performance
characteristics?
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5.0 M aterial/Component Control
5.1 M aterial/Component Specification and Purchasing Control
Note: Although purchasing is not specifically addressed in the current GM P regulation, it is incumbent upon the
user of components and materials to ensure quality of product, material or component.
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
5.1.1 Has each supplier/vendor of material or component been inspected/audited for proper manufacturing
controls?
(Review suppliers and audits and enter names, material supplied, and date last audited.)
5.2 M aterial/Component Receipt, Inspection, Sampling, and Laboratory Testing
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
5.2.1 §211.80(a) Does the facility have current written procedures for acceptance/rejections of drug products, containers,
closures, labeling and packaging materials? (List selected materials and components in notebook and
verify procedures.)
5.2.2 §211.80(d) Is each lot within each shipment of material or components assigned a distinctive code so material or
component can be traced through manufacturing and distribution?
5.2.3 §211.82(a) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of
damage, or contamination?
5.2.4 §211.82(b) Is the number of representative samples taken from a container or lot based on statistical criteria and
experience with each type of material or component?
5.2.5 §211.160(b) Is the sampling technique written and followed for each type of sample collected?
5.2.6 Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is
required?
5.2.7 §211.84(c)(2
)
*Containers are cleaned before samples are removed.
5.2.8 §211.84(c)(4
)
*Stratified samples are not composited for analysis.
5.2.9 §211.84(c)(5 *Containers from which samples have been taken are so marked indicating date and approximate
11. GM P AUDIT CHECKLIST
Page 11 of 11
) amount taken.
5.2.10 *Each sample container is clearly identified by material or component name, lot number, date sample
taken, name of person taking sample, and original container identification.
5.2.11 §211.84(d)(
1)(2)
*At least one test is conducted to confirm the identity of a raw material (bulk chemical or
pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA.
5.2.12 *If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a
written protocol to determine suitability for purpose.
5.2.13 §211.84(d)(
6)
*Microbiological testing is conducted where appropriate.
*Verify that these steps are included in written procedures unless more specific procedures are followed.
5.3 M aterial Component Storage and Handling
Verify that materials and components are stored and handled in a way that prevents contamination, mix-ups, and errors.
Question
Number
GM P
Section
Number if
Applicable
Question or Instruction
Yes, No,
or NA
5.3.1 §211.42(b) Are incoming material and components quarantined until approved for use?
5.3.2 Are all materials handled in such a way to prevent contamination?
5.3.3 Are all materials stored off the floor?
5.3.4 Are materials spaced to allow for cleaning and inspection?
5.3.5 §211.122(d) Are labels for different products, strengths, dosage forms, etc., stored separately with suitable
identification?
5.3.6 Is label storage area limited to authorized personnel?
5.3.7 §211.89 Are rejected components, material, and containers quarantined and clearly marked to prevent their
use?