The document discusses quality audits in the pharmaceutical industry. It defines audits and their purposes, which include ensuring processes meet requirements and assessing compliance and efficiency. The document outlines different types of audits, including internal audits conducted within a company, external audits conducted between companies, and regulatory audits conducted by oversight agencies. It describes audit goals like evaluating activities and documentation against standards and identifying areas for improvement. In addition, the benefits of effective auditing include quality management, preventing failures, and informing management.
The document discusses quality audits and their objectives in the pharmaceutical industry. It defines quality audits and explains that their main objectives are to verify manufacturing and quality control systems are under control and to allow for timely correction of potential problems. It describes different types of audits, including internal audits conducted by a company on itself, external audits conducted by companies on vendors, and regulatory audits conducted by agencies like the FDA. Finally, it outlines key elements of an effective quality audit program, such as written procedures, trained personnel, and periodic scheduled audits.
The document outlines the key aspects of conducting a quality auditing training course, including:
1) The background and basics of auditing, types of audits, auditor conduct and necessary skills, audit preparation and planning, performing the audit, and developing an audit report and follow up.
2) It discusses the importance of effective communication, maintaining objectivity and professionalism, and properly preparing, planning and executing audits.
3) The document provides guidance on selecting auditors, developing an audit plan and schedule, preparing checklists and understanding the audit site prior to the audit.
This document discusses audits in the pharmaceutical industry. It defines quality audits and GMP compliance audits. There are three main types of audits: internal audits conducted by a company on itself, external audits conducted by a company on its vendors, and regulatory audits conducted by bodies like the MCA and USFDA. Audits aim to verify compliance with regulations and allow for timely correction of problems. They help ensure quality systems are maintained and issues are identified and addressed. The roles of audits in quality assurance and quality control programs are also outlined.
An audit is a systematic, independent examination to determine if quality activities and results comply with planned arrangements and if those arrangements are effectively implemented and suitable to achieve objectives. Audits are performed to collect objective evidence that allows for an informed judgment about the system or product being audited. There are internal audits performed by a company's own employees and external audits performed by outside parties like customers or independent organizations. The goal of audits is to determine compliance and ensure quality.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
The document discusses quality audits and their objectives in the pharmaceutical industry. It defines quality audits and explains that their main objectives are to verify manufacturing and quality control systems are under control and to allow for timely correction of potential problems. It describes different types of audits, including internal audits conducted by a company on itself, external audits conducted by companies on vendors, and regulatory audits conducted by agencies like the FDA. Finally, it outlines key elements of an effective quality audit program, such as written procedures, trained personnel, and periodic scheduled audits.
The document outlines the key aspects of conducting a quality auditing training course, including:
1) The background and basics of auditing, types of audits, auditor conduct and necessary skills, audit preparation and planning, performing the audit, and developing an audit report and follow up.
2) It discusses the importance of effective communication, maintaining objectivity and professionalism, and properly preparing, planning and executing audits.
3) The document provides guidance on selecting auditors, developing an audit plan and schedule, preparing checklists and understanding the audit site prior to the audit.
This document discusses audits in the pharmaceutical industry. It defines quality audits and GMP compliance audits. There are three main types of audits: internal audits conducted by a company on itself, external audits conducted by a company on its vendors, and regulatory audits conducted by bodies like the MCA and USFDA. Audits aim to verify compliance with regulations and allow for timely correction of problems. They help ensure quality systems are maintained and issues are identified and addressed. The roles of audits in quality assurance and quality control programs are also outlined.
An audit is a systematic, independent examination to determine if quality activities and results comply with planned arrangements and if those arrangements are effectively implemented and suitable to achieve objectives. Audits are performed to collect objective evidence that allows for an informed judgment about the system or product being audited. There are internal audits performed by a company's own employees and external audits performed by outside parties like customers or independent organizations. The goal of audits is to determine compliance and ensure quality.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
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 discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
The document discusses quality audits in the pharmaceutical industry. It defines quality audits as evaluations of a manufacturer's compliance with Good Manufacturing Practices (GMP) in production and quality control. The goals are to detect any issues in GMP implementation and recommend corrective actions. The document outlines various types of quality audits, including self-inspections and elements of a systemic audit program like audit formats, checklists, trained personnel, and reporting. It emphasizes that quality audits help ensure GMP compliance, detect potential problems, improve quality programs, and increase management awareness of issues.
The Role of Regulatory GMP Audit in Pharmaceutical Companies.Jitendra Sonawane
This document discusses the role of regulatory GMP audits in pharmaceutical companies. It begins by defining auditing as an evaluation used to determine the effectiveness of quality controls. Regulatory agencies require internal audits to ensure compliance with cGMP regulations. The objectives of auditing are to determine conformity and effectiveness of quality systems. Audits are important for compliance, problem detection, and assessing control systems. The document outlines standard audit procedures, classifications, types of auditors, and the 10 step auditing process used in the pharmaceutical industry.
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.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Audit and regulatory compliance was presented by Bhalekar Soham Rajendra. The document discusses the definition of auditing, objectives of auditing, types of audits including internal, external and regulatory audits. It covers cGMP regulations, checklists for packaging and drug industry audits. Areas covered in a microbiology laboratory audit are discussed. Critical systems like water, water for injection, effluent treatment plant and HVAC that are audited in quality assurance and engineering departments are explained. The responsibilities of an auditor in providing an audit report are also highlighted.
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.
SUPAC, BACPAC, Post Marketing SurveillanceMANIKANDAN V
This document discusses various guidelines related to product development and technology transfer in the pharmaceutical industry. It covers SUPAC, BACPAC, and post-marketing surveillance. SUPAC provides guidance for scale-up and post-approval changes, categorizing changes into different levels based on their potential impact. BACPAC guidance addresses post-approval changes for bulk active pharmaceutical ingredients. Post-marketing surveillance involves monitoring adverse drug events after approval to ensure ongoing safety and effectiveness.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
1) Vendor qualification is the process used by finished dosage form manufacturers to approve vendors for active pharmaceutical ingredients (APIs) that will be used in products. It involves selecting vendors based on criteria like quality, delivery, price, and auditing them.
2) Vendors are categorized as A, B, or C depending on which tests they perform on APIs. Category A vendors perform all tests, B vendors are well-known and certified, and C vendors undergo full testing by the manufacturer.
3) The vendor qualification process determines if a vendor is suitable and can consistently supply quality APIs. It aims to develop long-term supplier relationships and ensure regulatory expectations are met.
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 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.
The document discusses different types of audits conducted in the pharmaceutical industry. It defines internal audits as self-audits conducted within a company to ensure compliance and identify areas for improvement. External audits refer to audits conducted by customers on suppliers or contractors. Regulatory audits are conducted by independent regulatory bodies like the FDA to ensure compliance with relevant regulations. The audits help companies evaluate processes, identify issues, and ensure quality standards are met.
CHAPTER-1 Management Audit and Planning procedure.pdfDr. Dinesh Mehta
Audits are conducted to ascertain the validity and reliability of the information; also to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products
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 discusses quality auditing in the pharmaceutical industry. It defines quality auditing and explains that it involves systematically examining quality systems to determine compliance. The document outlines different types of audits including internal, external, regulatory, product, process, and system audits. It discusses planning, conducting, and reporting on audits. The key objectives of audits are to ensure quality, assess effectiveness of quality assurance systems, and permit timely correction of any issues. Audits help build confidence in quality management practices and identify areas for improvement.
The document discusses quality audits in the pharmaceutical industry. It defines quality audits as evaluations of a manufacturer's compliance with Good Manufacturing Practices (GMP) in production and quality control. The goals are to detect any issues in GMP implementation and recommend corrective actions. The document outlines various types of quality audits, including self-inspections and elements of a systemic audit program like audit formats, checklists, trained personnel, and reporting. It emphasizes that quality audits help ensure GMP compliance, detect potential problems, improve quality programs, and increase management awareness of issues.
The Role of Regulatory GMP Audit in Pharmaceutical Companies.Jitendra Sonawane
This document discusses the role of regulatory GMP audits in pharmaceutical companies. It begins by defining auditing as an evaluation used to determine the effectiveness of quality controls. Regulatory agencies require internal audits to ensure compliance with cGMP regulations. The objectives of auditing are to determine conformity and effectiveness of quality systems. Audits are important for compliance, problem detection, and assessing control systems. The document outlines standard audit procedures, classifications, types of auditors, and the 10 step auditing process used in the pharmaceutical industry.
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.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Audit and regulatory compliance was presented by Bhalekar Soham Rajendra. The document discusses the definition of auditing, objectives of auditing, types of audits including internal, external and regulatory audits. It covers cGMP regulations, checklists for packaging and drug industry audits. Areas covered in a microbiology laboratory audit are discussed. Critical systems like water, water for injection, effluent treatment plant and HVAC that are audited in quality assurance and engineering departments are explained. The responsibilities of an auditor in providing an audit report are also highlighted.
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.
SUPAC, BACPAC, Post Marketing SurveillanceMANIKANDAN V
This document discusses various guidelines related to product development and technology transfer in the pharmaceutical industry. It covers SUPAC, BACPAC, and post-marketing surveillance. SUPAC provides guidance for scale-up and post-approval changes, categorizing changes into different levels based on their potential impact. BACPAC guidance addresses post-approval changes for bulk active pharmaceutical ingredients. Post-marketing surveillance involves monitoring adverse drug events after approval to ensure ongoing safety and effectiveness.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
1) Vendor qualification is the process used by finished dosage form manufacturers to approve vendors for active pharmaceutical ingredients (APIs) that will be used in products. It involves selecting vendors based on criteria like quality, delivery, price, and auditing them.
2) Vendors are categorized as A, B, or C depending on which tests they perform on APIs. Category A vendors perform all tests, B vendors are well-known and certified, and C vendors undergo full testing by the manufacturer.
3) The vendor qualification process determines if a vendor is suitable and can consistently supply quality APIs. It aims to develop long-term supplier relationships and ensure regulatory expectations are met.
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 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.
The document discusses different types of audits conducted in the pharmaceutical industry. It defines internal audits as self-audits conducted within a company to ensure compliance and identify areas for improvement. External audits refer to audits conducted by customers on suppliers or contractors. Regulatory audits are conducted by independent regulatory bodies like the FDA to ensure compliance with relevant regulations. The audits help companies evaluate processes, identify issues, and ensure quality standards are met.
CHAPTER-1 Management Audit and Planning procedure.pdfDr. Dinesh Mehta
Audits are conducted to ascertain the validity and reliability of the information; also to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
Audit and regulatory Compliance M.pharmacy Quality Assurance department Sem. 2 Introduction types, Objectives, Management of audit, Responsibilities, Planning Process, Information Gathering, Classifications of Deficiencies of auditing
This document discusses pharmaceutical audits. It defines audits and describes their purpose in ensuring quality compliance. The document outlines the types of audits, including internal, external, and regulatory audits. It discusses the objectives, management, responsibilities, planning process, and information gathering aspects of conducting pharmaceutical audits. The overall purpose of audits is to evaluate quality systems and processes and ensure they meet requirements for continuous improvement.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
This document discusses pharmaceutical quality audits. It begins by defining quality audits and their purpose in verifying quality management systems and identifying areas for improvement. It then describes the three main types of quality audits: internal audits conducted within a company, external audits conducted by customers on suppliers, and regulatory audits conducted by independent bodies. The document outlines the objectives, management, responsibilities, planning process, information gathering techniques, administration, and classification of deficiencies for quality audits. It concludes that quality audits can benefit companies by evaluating quality systems and determining if processes and products meet requirements.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
The document discusses various concepts related to quality including definitions of quality, quality management, quality control, quality assurance, ISO standards, total quality management, and documentation requirements. It provides definitions for quality as fitness for use, conformance to specifications, and meeting customer expectations. Quality management involves building quality into products through controls and preventing deficiencies. Quality control tests and inspects materials and products, while quality assurance reviews quality systems and procedures. Documentation is essential for defining and controlling quality systems.
The document discusses ISO 9000, a quality management standard that provides criteria for organizations to ensure customer satisfaction. It defines requirements for an effective quality management system, including meeting customer and regulatory requirements. The standard can be applied to any organization and aims to improve quality, increase profitability, and ensure products and services are fit for their intended purpose. Compliance is assessed through internal and external auditing. Benefits of certification include more efficient operations and increased customer satisfaction, marketing advantages, and profitability.
Second Party Audit and External Third Party AuditShantanuThakre3
Second Party Audit:- Second-party audit is when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
External Third Party Audit:-
A third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards.
This document provides an overview of quality assurance concepts, including definitions, types of audits, audit reporting, principles of quality audit programs, product audits, and sampling for product audits. It defines quality assurance as the total arrangements to ensure pharmaceutical products are suitable for their intended use. It describes internal, external, and regulatory audits. Audit reports should document findings, recommendations, and corrective actions. Product audits evaluate product quality and compliance to determine fitness for use, while sampling determines sample sizes for auditing mass produced products.
This document provides information on auditing and inspections. It defines key terms like audit, auditor, and auditee. Consistent auditing standards can provide benefits like effective GMP compliance assessments, reduced costs, and improved performance. Audits can be internal or external. The audit process involves planning, structuring, performing, reporting, and following up on findings. Inspections focus on current conditions, while audits review records to ensure all requirements were met. Qualified auditors with training and experience are important. Proper planning and cooperation are needed to avoid issues.
This ppt consists of types of FDA inspection, and how to prepare for FDA inspection of pharmaceutical mfg site, and what to do before FDA inspection, During FDA inspection, and after FDA inspection.
1. The document discusses social compliance audits and codes of conduct audits, outlining key concepts such as the purpose of audits, auditor roles and responsibilities, and audit types and strategies.
2. It explains that social compliance audits systematically and independently assess facilities against standards to determine if requirements are being met.
3. Effective audits are planned, independent, have management cooperation, and have a compliance orientation to evaluate implementation of standards.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
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How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
2. Introduction
The audit in simple terms could be defined as the inspection of a process or a system to ensure that it
meets the requirements of its intended use.
International organization for standardization (ISO) defines the audits as "Systematic, independent and
documented process for obtaining audit evidence and evaluating them objectively to determine the degree
to which the verification criteria are met" ..
Audits are conducted to ascertain the validity and reliability of the
information; also to provide an assessment of the internal control of a
system. It provides management with information on the efficiency with
which the company controls the quality of its processes and products
NIMESH SHARMA
3. In the pharmaceutical industry, audits are virtual means for
assessing compliance with the established objectives defined
in the quality system and thus paving the way for the
continuous improvement program by providing feedback to
management .
In food and drug administration (FDA) and ISO
environments, auditing of both compliance and
performance is essential.
Pharmaceutical audit experience includes the drafting and
revision of validation policies, guidelines and standard
operating procedures (SOP) from project qualification to
performance evaluation phases
NIMESH SHARMA
4. Goalsof audit
• The simple goal of this complex process is to evaluateexisting
• activities and documentation and determine if they meetthe
• established standards.An audit will evaluate the strengths and
• weaknesses of quality control and quality assurance processes,the
• results of which will help us to improve processes and build a better
• system for the benefit of the company. Every productmanufactured
• by a pharmaceutical company has characteristics that must be
• quantified or qualified by laboratory tests. Quality controland
• quality assurance are the necessary processes that play the role of
• control and balance system in pharmaceuticalindustry.
• With proper preparation and planning, the audit itself must easily
• achieve the intended purpose. Effective auditing andproper
• compliance with standards will help build brand reputationand
• avoid the negative effects of non-compliance, such as fines,bad
• public relations and court proceedings
NIMESH SHARMA
5. Objectives:
• Evaluating conformity of requirements to ISO 9001
• Evaluating conformity of documentation to ISO9001
• Judging conformity of implementation to documentation
• Determining effectiveness in meeting requirementsand
objectives
• Meeting any contractual or regulatory requirements for
auditing
• Providing an opportunity to improve the quality management
• system
• Permitting registration and inclusion in a list ofregistered
• companies
• Qualifying potential suppliers.NIMESH SHARMA
6. Benefits ofaudits
•Whilst there is usually low influence on regulatory inspections,
audits should be seen as a management tool to assess the
company’s in-house quality management system. Internal, as
well as external auditing, can help to achieve this goal. The
major benefits of an effective audit system can be summarized
asfollows:
• Managing a quality managementsystem
• Detecting in advance weak points, through identification of
unsatisfactory trends or situations
• Preventing quality failures, on the basis of quality data
reviewing
• Informing Senior Management about the quality level of
facilities
and/or operations
•Standardizing audits will optimize the output, the quality
level of audits will increase (and therefore the quality ofNIMESH SHARMA
7. • The auditee will understand that audits are not created to
control and criticize his work, but will improve the company's
performance. This will lead to a higher acceptance of the audits. He will see
audits as a chance to educate and improve his knowledge in terms of quality
related aspects.
• Combining audits of quality, safety, and environmentalmatters
will reduce the number of audits significantly which will givea greater
acceptance to the auditee and will save his time.
• Additional benefits can be achieved by pooling audits, for
example, Shared Third Party Audits.
• By establishing a high-quality audit system throughout the
industry, the level of compliance will increase. Mutual confidence building and
an improved relationship between the partners will be the result of these
efforts.
NIMESH SHARMA
8. Type ofaudits
The quality audit system mainly classified in three different
categories:
1. Internal audits
2. External Audits
3. Regulatory Audits
NIMESH SHARMA
9. Internal audits
• This type of audit is also known as First-Party Audit or self-
audit.
• Those auditing and those being audited all belong to the same
• organization. Internal audit is a professional activity that consists
• of advising organizations on how to achieve their goals in a
better
• way. The internal audit involves the use of a systematic
methodology
• to analyze business processes or organizational problems and
• recommend solutions. NIMESH SHARMA
10. The main objectives of internal audits can be summarized as follows:
1. To assist the internal control system.
2.Review of organizational policies and their operations.
3.Verify the accuracy and authenticity of errors and frauds.
4.Detection and prevention of errors and faults.
5.Safeguarding the assets
6.Applicability of accounting policies.
7.Helps in smooth functioning of the internal check system.
In a pharmaceutical facility for internal auditing, one requires to check mainly two things
namely,
Activities carried out by different departments and Documents maintained by
these departments.
For this purpose, a department-wise questionnaire and document list is required to be prepared
in detail
NIMESH SHARMA
11. External audits
• This type of audit is also known as Second-Party Audit. It refers to a
• customer conducting an audit on a supplier or contractor
• Although there are no strict legal requirements for this control. It is
• always advisable to evaluate the competence of the contractors in
• which we produce our products or carry out the analysis of our
• products or any other activity according to GMP. Performing these
• audits also offers important commercial advantages:
• External audits
• Develop knowledge and confidence in the partnership agreement
• Ensures that requirements are understood and met
• Allow the reduction of some activities (e. g. in-house quality
• control (QC) testing of starting materials)
• reduce the risk of failure (and, by implication, its costs)
• Many pharmaceutical industry suppliers are ISO 9001 or ISO 9002-
• certified and are regularly audited by their certification body.
• Pharmaceutical contract manufacturing or packaging companies will
• need to be licensed and will be subject to regulatory audits.NIMESH SHARMA
12. Regulatory audits
• This type of audit is also known as Third-Party Audit. Neither
• customer nor supplier conducts this type of audit. A regulatory
• agency or independent body conducts a third party audit for
• compliance or certification or registration purposes. [1]
• International regulatory bodies such as. Medicines and healthcare
• products regulatory agency (MHRA), UK, United States food and
• drug administration (USFDA), Therapeutic goods administration
• (TGA), Australia, Medicines control council (MCC), South Africa, etc.
• are responsible for carrying out these checks. There is a team to
NIMESH SHARMA
13. perform the audit; it must be composed of audit inspectors and a
multidisciplinary company team.
The company must have representatives from each of the following
departments: production, quality control, warehouse, maintenance,
administration/personnel and marketing/sales.These audits can be
performed without warning (MHRA currently performs around ten
percent of its inspections in the UK in this way) as manufacturers are
required to always comply with GMPs. Regulatory bodies in other
countries where products are sold can also audit companies (e. g. FDA
audits European manufacturers).
NIMESH SHARMA
14. Principles ofaudits
• Integrity
• Fair presentation
• Due professional care
• Confidentiality
• Independence: the basis for the impartiality of the audit
and the objectivity of the audit conclusions
• Evidence-based approach: the rational method for
achieving reliable and reproducible audit conclusions
in a systematic audit process
NIMESH SHARMA
15. • The auditor within the audit system
• An auditor is defined by ISO 19011 as a person with the
competence
• to perform an audit. To perform an audit, the auditor must be
• authorized for that particular audit.
• Auditor's responsibility
• The auditor has the following responsibilities:
• Assist in the selection of the team and inform theteam
• Responsibility to plan and manage all phases of the
audit Represent the audit team with the auditee
• Control conflicts and manage difficultsituations
• Direct and control all meetings with the team and the auditee
• Make decisions about audit issues and the quality system
• Report the results of the audit without delay
• Report the main obstacles encountered
• Report critical non-conformances immediately
• Possesses effective communication skillsNIMESH SHARMA
16. Audits activity
Information gathering:
Information is simply the facts or knowledge provided or
learned. It
Can be tacit, in people’s heads, or explicit, in documents-
electronicor Hard copy .
Audit evidence is any information used by the auditor to
determine if the audited information is in accordance with the
established criteria and to arrive at the conclusions on which
theaudit opinion is based. Internal Audit Evidence includes
any data, information, process flows, vouchers, bills, memos,
contracts or transactions NIMESH SHARMA
18. Administration
The internal audit team must have the confidence and trust of
thekey stakeholders it works with maintained by having an
effective working relationship
• Chief Executive
• Board of Directors
• Audit Committee
• Senior management
• External auditor
• Other reviewers
NIMESH SHARMA