This document provides a summary of Satyanarayana's qualifications and experience. He has over 10 years of experience in quality assurance and has worked in various roles ensuring compliance with quality standards. He holds an MSc in Biotechnology and has received training in quality management systems. His previous roles involved managing quality systems, conducting audits, ensuring regulatory compliance, and overseeing laboratory operations and testing.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP aims to assure regulatory authorities that safety study data submitted to them are reliable and accurate. The document traces the history and development of GLP from cases of poor laboratory practices in the 1970s. It describes the key principles of GLP including requirements for facilities, equipment, test systems, personnel responsibilities, standard operating procedures, and reporting of study results. Adherence to GLP aims to produce high quality and integrity of nonclinical safety data.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP forms part of Good Manufacturing Practices and aims to minimize product failures by avoiding shortcuts. The document outlines the scope of GLP regulations including study types covered and excluded. It also summarizes the key requirements of GLP regulations regarding organization, personnel, facilities, equipment, operations, test articles, protocols, records and reports. Finally, it discusses disqualification of non-compliant testing facilities.
This document provides an overview of Good Laboratory Practice (GLP) from both a regulatory and quality systems perspective. It discusses the scope and importance of GLP for ensuring quality test data, sound laboratory management, and accurate reporting. Key aspects of a GLP-compliant quality system are summarized, including organization, facilities, equipment, documentation, personnel training, sampling methods, and self-inspections. Compliance with GLP is mandated by various regulations to ensure patient safety, meet regulatory expectations, and maintain high customer confidence.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP aims to assure regulatory authorities that safety study data submitted to them are reliable and accurate. The document traces the history and development of GLP from cases of poor laboratory practices in the 1970s. It describes the key principles of GLP including requirements for facilities, equipment, test systems, personnel responsibilities, standard operating procedures, and reporting of study results. Adherence to GLP aims to produce high quality and integrity of nonclinical safety data.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP forms part of Good Manufacturing Practices and aims to minimize product failures by avoiding shortcuts. The document outlines the scope of GLP regulations including study types covered and excluded. It also summarizes the key requirements of GLP regulations regarding organization, personnel, facilities, equipment, operations, test articles, protocols, records and reports. Finally, it discusses disqualification of non-compliant testing facilities.
This document provides an overview of Good Laboratory Practice (GLP) from both a regulatory and quality systems perspective. It discusses the scope and importance of GLP for ensuring quality test data, sound laboratory management, and accurate reporting. Key aspects of a GLP-compliant quality system are summarized, including organization, facilities, equipment, documentation, personnel training, sampling methods, and self-inspections. Compliance with GLP is mandated by various regulations to ensure patient safety, meet regulatory expectations, and maintain high customer confidence.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
Kalyani Kadam has over 20 years of experience in quality assurance and microbiology. She currently works as an Application Specialist at Span Biotronics, where she is involved in product development, validation, and customer support. Previously, she held roles such as Project Manager, Assistant Product Manager, and Microbiologist at various companies. Kadam has a Bachelor's degree in Microbiology and qualifications in nutrition, sterility approval, and laboratory quality systems. She is married and resides in Mumbai, India.
PPT ON GOOD LABORATORY PRACTICES (GLP)GOVIND YADAV
The document discusses Good Laboratory Practice (GLP) guidelines. It notes that in the 1970s, the FDA discovered many cases of poor laboratory practices and fraudulent activities in the US. This led to the establishment of GLP principles to ensure reliable and high-quality non-clinical safety studies. GLP guidelines cover facilities, equipment, standard operating procedures, personnel training, record-keeping, and quality assurance programs. The goal of GLP is to ensure that experimental data accurately reflect the results and that studies are conducted in accordance with the principles of good laboratory practice.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s after discovering fraudulent activities and poor lab practices that undermined the quality and integrity of data submitted to the FDA. GLP aims to ensure that studies are conducted properly according to standardized operating procedures and that accurate records are kept. This allows data from non-clinical studies to be reliably submitted to regulatory authorities. Key aspects of GLP include requirements for facilities, test systems, operating procedures, personnel qualifications, quality assurance programs, and record keeping. Following GLP helps assure reproducibility and quality of results.
This document discusses Good Laboratory Practices (GLP) regulations and microbiology laboratory practices. It provides background on how GLP regulations were developed in response to malpractice issues and aim to ensure proper management and organization of studies. The key points of GLP include resources, characterization of test items, study plans and procedures, documentation of results, and quality assurance. The document also outlines biosafety levels and practices for handling different types of microorganisms, as well as guidelines for media preparation, culture maintenance, laboratory equipment use, and safety.
Oppi guidelines on good laboratory practices(glp)dilip1097
This document provides guidelines for good laboratory practices (GLP) for quality control laboratories. It outlines requirements for personnel, facilities, documentation, calibration of equipment, handling of out-of-specification results, validation of analytical methods, change control, laboratory reagents and reference standards, safety, training, quality audits, and management review. The objective is to facilitate proper application of GLP principles for testing facilities.
This document outlines the principles of Good Laboratory Practices (GLP). GLP provides a framework for conducting laboratory studies and ensuring quality and integrity of data. The key points covered include defining GLP and its purpose of certifying valid study steps. Ten GLP principles are described relating to laboratory organization, facilities, equipment, test systems, methods, and record keeping. Maintaining proper documentation, conducting quality assurance inspections, and retaining records and materials are emphasized. In conclusion, following GLP guidelines helps produce high quality data and ensures proper laboratory management.
GLP regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
contented and precise . good laboratory practices is an integral part of an developed and a regulated pharmaceutical market.there are certain qualities to be procured by an analyst to reach the top notch level.
The document discusses Good Laboratory Practice (GLP) guidelines for conducting non-clinical laboratory studies. It provides an introduction to GLP, describing how the guidelines were developed by the FDA and OECD in response to issues with data integrity. It then summarizes key aspects of the US FDA, OECD, and Indian draft GLP guidelines regarding the scope, organization, roles and responsibilities of testing facility management, study directors, quality assurance units, principal investigators, and study personnel involved in GLP-compliant non-clinical studies.
Good Laboratory Practice (GLP) is a quality system for conducting safety testing of products like pharmaceuticals, pesticides, and chemicals. It aims to develop quality test data, ensure mutual acceptance of data between countries, and protect human health and the environment. GLP provides principles for test facility organization and management, quality assurance programs, facilities, equipment, study conduct, recordkeeping, and reporting to ensure safety studies are properly planned, performed, monitored, and documented. Key parties involved include test facility management, study directors, quality assurance personnel, and study staff.
Good Laboratory Practice (GLP) is a formal set of principles that were established by the FDA in 1978 to ensure the quality and integrity of safety testing data submitted for regulatory purposes. GLP provides guidelines for conducting non-clinical laboratory studies, including requirements for facilities, equipment, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. The purpose of GLP is to ensure testing is properly conducted and documented so that results are reliable and can be used to support regulatory decisions.
This document provides an overview of Good Laboratory Practice (GLP) standards. GLP standards are concerned with ensuring quality in non-clinical health and safety studies. They aim to promote quality data and sound management of laboratory studies. GLP standards apply to non-clinical studies intended to evaluate safety for submission to regulatory authorities. Key aspects of GLP covered include resources, facilities, equipment, personnel responsibilities and training, characterization of test items, study protocols, record keeping, and quality assurance.
The document provides an overview of ICH guidelines and CPCSEA guidelines for quality control and quality assurance in pharmaceutical research. It discusses the ICH guidelines for quality, safety, efficacy, and multidisciplinary topics. It then summarizes the various Q-series ICH guidelines covering stability testing, analytical validation, impurities, pharmacopoeias, biotechnological products, specifications, and more. It concludes with an overview of the objectives, functions and various aspects of animal husbandry and management covered by the CPCSEA guidelines.
This document summarizes a presentation given by Cato Research, a full-service contract research organization. Cato provides drug development services globally with over 300 employees. They have therapeutic expertise across many disease areas. Cato ensures quality assurance through adherence to Good Laboratory Practice regulations, which require proper documentation, record keeping, and quality control procedures. The Quality Assurance Unit at Cato monitors studies and ensures compliance with regulations.
This document discusses the role of GLP compliance in generating accurate and reproducible bioequivalence data. It provides an overview of the evolution of GLP guidelines and the key fundamentals of GLP, including resources, rules and procedures, test characterization, documentation, and quality assurance. It notes that while BE studies involve human subjects and must comply with GCP, the analytical laboratory work should also adhere to GLP principles. Key regulatory guidelines on applying GLP to bioanalytical methods from the US FDA, EMEA, and ICH are summarized. Maintaining both GCP and GLP compliance through validated methods, quality systems, training and oversight can help ensure the best BE study results and regulatory acceptance.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
The document discusses designing websites that explode across multiple touchpoints and contexts of use. It provides lessons learned from a case study of designing an exploding website for the Association of Public Libraries. Key lessons include developing an exploding strategy that transforms services for new contexts, using collaborative design methods like sketching and storyboards, and designing adaptive components and context-rich user profiles instead of fixed structures. The goal is to design fragmented, impulse-driven experiences across multiple touchpoints.
Datasheet Fluke AC Measurement Standard. Informasi lebih detail hubungi PT. Siwali Swantika, Jakarta Office : 021-45850618 atau Surabaya Office : 031-8421264
Kalyani Kadam has over 20 years of experience in quality assurance and microbiology. She currently works as an Application Specialist at Span Biotronics, where she is involved in product development, validation, and customer support. Previously, she held roles such as Project Manager, Assistant Product Manager, and Microbiologist at various companies. Kadam has a Bachelor's degree in Microbiology and qualifications in nutrition, sterility approval, and laboratory quality systems. She is married and resides in Mumbai, India.
PPT ON GOOD LABORATORY PRACTICES (GLP)GOVIND YADAV
The document discusses Good Laboratory Practice (GLP) guidelines. It notes that in the 1970s, the FDA discovered many cases of poor laboratory practices and fraudulent activities in the US. This led to the establishment of GLP principles to ensure reliable and high-quality non-clinical safety studies. GLP guidelines cover facilities, equipment, standard operating procedures, personnel training, record-keeping, and quality assurance programs. The goal of GLP is to ensure that experimental data accurately reflect the results and that studies are conducted in accordance with the principles of good laboratory practice.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s after discovering fraudulent activities and poor lab practices that undermined the quality and integrity of data submitted to the FDA. GLP aims to ensure that studies are conducted properly according to standardized operating procedures and that accurate records are kept. This allows data from non-clinical studies to be reliably submitted to regulatory authorities. Key aspects of GLP include requirements for facilities, test systems, operating procedures, personnel qualifications, quality assurance programs, and record keeping. Following GLP helps assure reproducibility and quality of results.
This document discusses Good Laboratory Practices (GLP) regulations and microbiology laboratory practices. It provides background on how GLP regulations were developed in response to malpractice issues and aim to ensure proper management and organization of studies. The key points of GLP include resources, characterization of test items, study plans and procedures, documentation of results, and quality assurance. The document also outlines biosafety levels and practices for handling different types of microorganisms, as well as guidelines for media preparation, culture maintenance, laboratory equipment use, and safety.
Oppi guidelines on good laboratory practices(glp)dilip1097
This document provides guidelines for good laboratory practices (GLP) for quality control laboratories. It outlines requirements for personnel, facilities, documentation, calibration of equipment, handling of out-of-specification results, validation of analytical methods, change control, laboratory reagents and reference standards, safety, training, quality audits, and management review. The objective is to facilitate proper application of GLP principles for testing facilities.
This document outlines the principles of Good Laboratory Practices (GLP). GLP provides a framework for conducting laboratory studies and ensuring quality and integrity of data. The key points covered include defining GLP and its purpose of certifying valid study steps. Ten GLP principles are described relating to laboratory organization, facilities, equipment, test systems, methods, and record keeping. Maintaining proper documentation, conducting quality assurance inspections, and retaining records and materials are emphasized. In conclusion, following GLP guidelines helps produce high quality data and ensures proper laboratory management.
GLP regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
contented and precise . good laboratory practices is an integral part of an developed and a regulated pharmaceutical market.there are certain qualities to be procured by an analyst to reach the top notch level.
The document discusses Good Laboratory Practice (GLP) guidelines for conducting non-clinical laboratory studies. It provides an introduction to GLP, describing how the guidelines were developed by the FDA and OECD in response to issues with data integrity. It then summarizes key aspects of the US FDA, OECD, and Indian draft GLP guidelines regarding the scope, organization, roles and responsibilities of testing facility management, study directors, quality assurance units, principal investigators, and study personnel involved in GLP-compliant non-clinical studies.
Good Laboratory Practice (GLP) is a quality system for conducting safety testing of products like pharmaceuticals, pesticides, and chemicals. It aims to develop quality test data, ensure mutual acceptance of data between countries, and protect human health and the environment. GLP provides principles for test facility organization and management, quality assurance programs, facilities, equipment, study conduct, recordkeeping, and reporting to ensure safety studies are properly planned, performed, monitored, and documented. Key parties involved include test facility management, study directors, quality assurance personnel, and study staff.
Good Laboratory Practice (GLP) is a formal set of principles that were established by the FDA in 1978 to ensure the quality and integrity of safety testing data submitted for regulatory purposes. GLP provides guidelines for conducting non-clinical laboratory studies, including requirements for facilities, equipment, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. The purpose of GLP is to ensure testing is properly conducted and documented so that results are reliable and can be used to support regulatory decisions.
This document provides an overview of Good Laboratory Practice (GLP) standards. GLP standards are concerned with ensuring quality in non-clinical health and safety studies. They aim to promote quality data and sound management of laboratory studies. GLP standards apply to non-clinical studies intended to evaluate safety for submission to regulatory authorities. Key aspects of GLP covered include resources, facilities, equipment, personnel responsibilities and training, characterization of test items, study protocols, record keeping, and quality assurance.
The document provides an overview of ICH guidelines and CPCSEA guidelines for quality control and quality assurance in pharmaceutical research. It discusses the ICH guidelines for quality, safety, efficacy, and multidisciplinary topics. It then summarizes the various Q-series ICH guidelines covering stability testing, analytical validation, impurities, pharmacopoeias, biotechnological products, specifications, and more. It concludes with an overview of the objectives, functions and various aspects of animal husbandry and management covered by the CPCSEA guidelines.
This document summarizes a presentation given by Cato Research, a full-service contract research organization. Cato provides drug development services globally with over 300 employees. They have therapeutic expertise across many disease areas. Cato ensures quality assurance through adherence to Good Laboratory Practice regulations, which require proper documentation, record keeping, and quality control procedures. The Quality Assurance Unit at Cato monitors studies and ensures compliance with regulations.
This document discusses the role of GLP compliance in generating accurate and reproducible bioequivalence data. It provides an overview of the evolution of GLP guidelines and the key fundamentals of GLP, including resources, rules and procedures, test characterization, documentation, and quality assurance. It notes that while BE studies involve human subjects and must comply with GCP, the analytical laboratory work should also adhere to GLP principles. Key regulatory guidelines on applying GLP to bioanalytical methods from the US FDA, EMEA, and ICH are summarized. Maintaining both GCP and GLP compliance through validated methods, quality systems, training and oversight can help ensure the best BE study results and regulatory acceptance.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
The document discusses designing websites that explode across multiple touchpoints and contexts of use. It provides lessons learned from a case study of designing an exploding website for the Association of Public Libraries. Key lessons include developing an exploding strategy that transforms services for new contexts, using collaborative design methods like sketching and storyboards, and designing adaptive components and context-rich user profiles instead of fixed structures. The goal is to design fragmented, impulse-driven experiences across multiple touchpoints.
Datasheet Fluke AC Measurement Standard. Informasi lebih detail hubungi PT. Siwali Swantika, Jakarta Office : 021-45850618 atau Surabaya Office : 031-8421264
The document provides the solutions to 5 math problems involving addition, subtraction, and multiplication. Each problem is presented on its own slide, and the solutions are provided at the end. The problems include 27 + 94 + 73, 20 - 13 + 3, 2.5 x 3.7 x 4, 30 + 7 x 4, and 6 x 7 + 5 x 4, with the corresponding solutions being 194, 10, 37, 58, and 62.
The document is a link to the website www.powtoon.com. Powtoon is an online animation platform that allows users to create, share, and present animated videos and presentations. It provides animation tools and templates to help users with no experience create professional-looking animated videos and presentations.
Este documento describe varias razas de perros comunes. Menciona el Husky Siberiano, Beagle, Yorkshire, Bull Terrier, Pastor Alemán, Rottweiler, Boxer, Collie, Chihuahua, Bulldog y Labrador como algunas de las razas más populares, y proporciona breves descripciones de sus orígenes, características y temperamentos.
Los metales son elementos químicos que conducen bien la electricidad y el calor. Algunos metales comunes son el aluminio, cobre, estaño, cinc, latón, bronce y acero. El aluminio es ligero y se extrae de la bauxita. El cobre es un buen conductor eléctrico y se usa en cables. El estaño y el cinc se usan para recubrir otros metales y prevenir la corrosión. El latón y el bronce son aleaciones de cobre con cinc y estaño respectivamente. El acero es una aleación de hier
Upaya Meningkatkan Minat Baca MasyarakatWahyudi Mukti
This document outlines the ASEAN Economic Community Blueprint 2025, which builds upon the ASEAN Economic Community Blueprint 2015 to further economic integration in Southeast Asia over the next decade. The blueprint envisions a highly integrated ASEAN economy through measures like eliminating remaining tariffs and non-tariff barriers, streamlining rules of origin, implementing trade facilitation measures, liberalizing services trade and investment, enhancing financial integration, and promoting connectivity. It aims to create a competitive, innovative, and resilient economic community that narrows development gaps and improves people's livelihoods across ASEAN.
Good Laboratory Practices Mubashir MaqboolMUBASHIR WANI
GLP (Good Laboratory Practice) is a quality system for managing non-clinical laboratory studies to ensure reliability and integrity of test data. It outlines requirements for facility organization, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. GLP aims to ensure studies are well-designed, conducted and documented according to all principles to allow for traceability and reproducibility of results.
Jagadmbay Prasad Singh is a Quality Professional with over 12 years of experience in the pharmaceutical industry. He holds an M.Sc. in Organic Chemistry and a PG Diploma in Applied Analytical Chemistry. His career includes positions at various pharmaceutical companies where he was responsible for quality control, validation activities, audits, and ensuring compliance. He has a strong background in analytical testing and laboratory instrumentation. His goal is to integrate quality guidelines to improve business and patient well-being.
This curriculum vitae summarizes the qualifications of Mohana Rangan, including education, language skills, computer skills, experience operating analytical instruments, training programs attended, and professional experience conducting chemical analysis and validating test methods. Mohana has 9 years of experience in an instrumentation role, operating various LC-MS/MS, GC-MS/MS, HPLC, GC, and other analytical instruments to analyze veterinary drug residues, pesticides, and other chemicals in food, water, and pharmaceutical samples.
Lindsay LaMere has over 10 years of experience in clinical laboratory quality assurance and management. She currently works as a Quality Assurance Specialist at Sutter Health, where she coordinates quality activities for over 200 tests and 2 million samples per year. Previously, she held positions as a Laboratory Manager and Clinical Laboratory Scientist. She has extensive experience with regulatory compliance, process improvement, auditing, and training.
The document is a resume for Kanagasabapathi S., highlighting his expertise and 10+ years of experience in bioanalytical method development and drug discovery. It summarizes his responsibilities developing over 1000 analytical methods for small molecules, conducting ADME assays, and managing projects. Currently he works as a Research Scientist at Syngene International Ltd, where he leads projects and trains junior scientists.
This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
Biju M.S. is an Assistant Manager of Quality for Devayani Food Industries in Goa, India. He has over 10 years of experience in quality assurance and control roles in the food, bulk drug, and fermentation industries. He holds an M.Sc. in Microbiology and has experience developing and implementing quality programs including ISO, HACCP, GMP, and 5S standards. Currently, he performs internal audits, vendor development, product testing, and ensuring compliance with quality and food safety regulations.
Anjali Malhotra has over 20 years of experience in quality assurance and clinical laboratory testing. She currently works as a Quality Assurance Manager at LabCorp Clinical Trials, where she oversees quality objectives and compliance with regulations. Previously, she was a Quality Assurance Coordinator and Cytogenetics Supervisor at Quest Diagnostics, where she established quality management systems and automated processes. Malhotra holds an MBA in Health Care Administration and degrees in Medical Technology and Microbiology and Biochemistry. She maintains certifications in clinical cytogenetics, quality assurance, and Six Sigma.
Janet Willis has over 10 years of experience in analytical chemistry and quality assurance. She holds a B.S. in Chemistry from UC San Diego and has worked at various pharmaceutical companies performing analytical testing, method development and validation, quality control, and quality assurance activities. Her experience includes HPLC, GC, UV-Vis, ELISA testing and method troubleshooting. She is proficient in GLP, GCP, and cGMP regulations and analytical software programs.
Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
Sapna Yadav has over 3 years of experience in life sciences and biotechnology industries. She currently works as a Quality Control Lead at ThermoFisher Scientific, where she oversees manufacturing processes and product quality. Previously she has worked as an Associate Manufacturing Technician synthesizing DNA, and has internship experience in clinical research. She has a Bachelor's degree in Biological Sciences and certification in clinical trial monitoring.
This document provides a summary of Manoj Kumar Parida's professional experience and qualifications. It lists his current role as Senior Manager of Quality Control (Microbiology) at Emcure Pharmaceuticals Ltd. It then outlines his 16 years of experience in microbiology roles at various pharmaceutical companies. The document details his responsibilities in directing microbiology laboratories and ensuring compliance with regulatory standards.
Nandakumar Narayanan Kutty is a highly qualified microbiologist currently pursuing an MBA. He has experience in quality control and marketing for healthcare companies in Abu Dhabi and Bengaluru. He holds a Six Sigma Green Belt certification and has implemented lean six sigma initiatives to improve productivity. Kutty is seeking a position in healthcare quality or marketing where he can apply his expertise in auditing, quality control, and driving business growth.
This document provides a summary of Douangmala Williams' skills and experience for a Histology Supervisor position. She has over 10 years of experience in histology, including supervising personnel, performing IHC staining, special stains, tissue processing, and ensuring quality control. Her background includes positions as an AP Supervisor at Labcorp, Histology Group Lead at Quest Diagnostics, and Lead Histotechnologist at Casa Grande Regional Hospital. She has a Bachelor's degree in Biomedical Sciences and multiple certifications.
Good Laboratory Practices (GLP) are quality standards for designing, conducting, recording, and reporting non-clinical research studies that generate data as safety and efficacy information for health or environmental regulations. GLP was developed to increase quality and validity of non-clinical safety studies by defining roles, responsibilities, standard operating procedures, and documentation requirements. Key elements of GLP include management and quality assurance systems, personnel qualifications, facility organization and maintenance, test and control article characterization, standard operating procedures, documentation, and reporting.
Shikha Sharma has over 6 years of experience in quality control and R&D for pharmaceutical and biologics companies. She has expertise in cGMP quality systems, environmental monitoring, process development, cell culture, assay development and validation. Her technical skills include microbiology testing, media preparation, stability studies, and cell banking. She is proficient in cGMP documentation and has experience transferring technologies from R&D to manufacturing.
Group_3_M - Cancer Research Laboratory.pptxNafeesaHanif1
This presentation discusses good laboratory practices (GLP) in cancer research laboratories. It outlines the key working procedures in cancer research, including formulating questions, gathering tools, conducting experiments, and analyzing and sharing findings. The importance of adhering to GLP is emphasized to ensure reliable outcomes through maintaining high standards. Certifications like CLIA, AAALAC, CAP, IACUC, and IBC are also covered that are relevant for cancer research. Quality assurance and quality control are important for achieving accurate results and preventing errors. In summary, following proper procedures, regulations, and implementing GLP and quality measures helps produce trustworthy data to advance cancer research.
S. Lakshmi Narayanan is an analytical research scientist with over 8 years of experience in method validation, development, and analysis in the pharmaceutical industry. He has expertise in GC, HPLC, UV-Vis spectroscopy, dissolution testing, and water content analysis. Narayanan is knowledgeable in GMP and GLP compliance and has experience managing projects and documenting results. He holds an M.Phil. in chemistry and has worked for several companies conducting routine analysis, method development and validation, process optimization, and documentation.
This document discusses quality assurance in mycobacteriology laboratories. It describes the three main components of a quality assurance system as quality control, external quality assessment, and quality improvement. Quality control procedures should address pre-analytical, analytical, and post-analytical phases of testing. Monitoring performance indicators such as contamination rates, turnaround times, and proficiency testing scores helps to evaluate laboratory performance and identify areas for improvement.
1. SATYANARAYANA
QUALITY ASSURANCE Mobile: +91- 9502163050
mohansatyap@gmail.com +91- 8143912045
SUMMARY
Accomplished QA professional with 10 years of progressive experience and proven record of significant,
successful contribution in quality management, project management, process improvement, business analysis/
evaluation, product-development life cycle methodologies, supplier management, and quality-management
systems, processes, standards, and systems in a wide range of organizations that previously had no standards
or programs in place
CIRTIFICATES
Participated in four days training programme “INTERNAL AUDITOR TRAINING PROGRAM”
based on ISO 9001:2000 AND ISO/IEC 17025:2005 conducted at Magene life sciences from 3rd
dec
-6th
dec2007.
Participated in four days training programme on “LABORATORY QUALITY MANAGEMENT &
INTERNAL AUDIT” as per ISO 15189:2007 conducted by CETE from 28th
sep- 1st
Oct 2011.
Participated in four days training programme “ADVANCED KEY OPERATORS TRAINING
PROGRAMME” held at Ortho Clinical Diagnosics from 20 – 23 June, 2012
ACADEMIC QUALIFICATION :
M.Sc, Biotechnology 2004 from Nagarjuna University with 1st
Div (62%)
B.Sc, Life Sciences 2002 from Nagarjuna University with 2nd
Div (56%)
XIIth
Class 1998 from National Open School with 2nd
Div (54%)
PATHCARELABS 30th
SEP. 2013 – JULY.2014
Asst. Manager-QA, PATHCARELABS, chiryala, Distt. : Ranga Reddy , Telangana State, India
JOB RESPONSIBILITIES AS ASST. MANAGER-:
(a) Provide hands on training to the new recruits. Ensuring all testing procedures are conducted as
per defined sop. Ensuring testing is conducted as per the specified turn around time. Ensuring
accuracy & correctness of results by strict compliance to defined sop, calibration, quality control,
procedure & training of personnel. Ensure STAT (urgent) reporting. Ensure efficiency of testing by
proper planning & optimum utilization of supplies, equipment, work allocation & supervision of
all operations conducted in the section. Initiating improvements in existing SOP. Ensure optimum
utilization of manpower, equipment, reagents & time. Stock management of procured material
from store. Ensuring the space, equipment & other ancillary equipment are maintained in
optimum working condition & managing critical situation like equipment break down, staff
shortage, reagent shortage, Unavailability or sudden heavy workload. Maintenance of records.
(c) Preparation for compliance of concerned Statutory and Regulatory requirements
(d) Responsible for all aspects of the Quality System for the laboratory under the guidance of the
Director Lab operations. Review and update the Quality Manual. Monitor laboratory practices to
verify continuing compliance with policies and procedures. Evaluate instrument calibration and
maintenance records. Ensure the validation of new technical procedures. Investigate technical
problems, propose remedial actions, and verify their implementation. Propose corrections and
improvements in the quality system
(e) Responsibilities include development of method validation documentation. A recognized industry
leader specializing in GLP compliance and validation, including conducting GLP audits, providing
regulatory compliance training, compliance and validation results. Preparation of MRM, Planning
the internal Audits. Conducting In-house Calibration of Laboratory Equipment Preparing trend
analysis for Quality indicators. Assist in Internal and External Quality Systems Audits and the
CAPA implementation.
JOB RESPONSIBILITIES AS INTERNAL AUDITOR:
(a) Audit of Quality Management System as per ISO 15189:2007, NABL & CAP
(b) Business development for above Management system
2. KIMS HOSPITALS 2010 - 2013
Quality Manager-KIMS Hospitals, Siddhartha Nagar, Pinamaneni poly clinic, Distt. : Krishna,
Andhra Pradesh, India
1. Method validation studies, method comparison studies and integrity studies. Monitoring IQC
and EQAS performance in the departments and taking corrective action for outliers.
2. Document management, identification of internal training needs and assistance for
implementation of training programs, periodic review of personnel files, assistance for vendor
selection and performance monitoring.
3. Planning internal audit schedule and collection center audit schedule to identify the staff
training needs and ensure that appropriate training (Initial and Periodic) are carried out for
Quality Assurance staff and all other technical staff working at the Unit. Preparing Standard
Operating Procedures (SOP).
4. Ensure compliance with CLIA requirements and laboratory procedures, including
maintenance of laboratory equipment, resolving complex clinical instrument problems.
5. Evaluated quality control within the laboratory using standard lab test and measurement
controls.
6. Handled the gamut of activities encompassing Bioassays, Fully Automated Biochemistry
analyzers (vitros350,) cell counters (Beckmen coulter HMX, Sysmax I 1800) Hormonal
analyzer Beckmen coulter Asscess2 and semi automated chem-7, Easylyte , Radiometer ABG,
CA-50. Perform complex laboratory tests and procedures on blood and other body fluids,
according to laboratory policies. Conducting In-house Calibration of Laboratory Equipment.
MAGENE LIFESCIENCES PVT LTD 2007 - 2010
Working on down stream process of therapeutic proteins (interlukin-2 and antimycin).
Laboratory testing of protocol changes in Downstream processes prior to scaling up to pilot plant.
Method development on Äkta Explorer system.
Purification of specific secondary metabolites. Sample preparation and size exclusion
chromatography.
Culture cultivation of fungal culture cultivation and E.coli on laboratory media.
Protein purification Techniques: Protein purification by Ion exchange chromatography (IEC),
Gel filtration chromatography or Size exclusion chromatography (SEC), Affinity chromatography
(AC) using AKTA prime, AKTA Explorer platforms.
Protein Characterization Techniques:
Characterization of proteins by Bradford and Lowry methods, SDS-PAGE analysis, Iso Electric
Focusing (IEF), Western Blotting, and silver staining.
Molecular & Immuno Techniques:
Isolation of DNA and RNA, Agarose Gel Electrophoresis, PCR, cloning, restriction digestion, Gel
Imaging System (UVP), Shaker incubators, DNA Electrophoresis system (Bio-Rad), UV-Vis
Spectrophotometer, Gel dryer (Amersham Biosciences).
1Southern/Northern blot chamber (Amersham Biosciences) Western transfer apparatus
(Amersham Biosciences) Refrigerated centrifuges (Beckman Coulter) Protein Electrophoresis (Bio-
Rad).
Fermentation techniques:
Flask level fermentation techniques, TLC, Quantification of unknown sample by fluorescence.
THYROCARE TECHNOLOGIES Ltd., MUMBAI 2005 to 2007
Key Deliverables across the tenure
Handled the gamut of activities encompassing Bioassays, Biochemistry analyzers, ELISA & CLIA,
western blotting. Conducted analysis of thyroid hormones, tumor markers, Precision studies, and
statistics studies of viral diseases, hormones analysis, and serum samples. Ensuring complete in-
process quality control and continuous improvement in process capabilities. Conducting Routine
maintenance, calibration and troubleshooting for analytical equipment on a regular basis for
higher productivity and efficiency. Foreseeing performance bottlenecks and taking corrective
measures to avoid the same.
Documentation/Quality Compliance.
Ensuring compliance of various quality measures by maintenance of appropriate requisite
documentation/ records. Imparting training to all employees, pertaining to quality
3. implementation and compliance. Participating in ISO Certification, NABL, CAP ,Surveillance and
recertification audits.
PROJECTS IN MY MASTER’S
Title: Isolation of DNA from (Bacillus Thuringensis) BT Cotton Seed and Qualitative Estimation of
BT Toxin, National Institute of Nutrition.
Duration : Three months (May’03 to July’ 03)
Guide : Dr. Remash V. Bhat (Food and Drug toxicology)
Title: Exposure to various Fermentation Processes – Quality Control of Diphtheria, Pertusis,
Tetanus & Rabies, Group of Vaccines at Pasteur Institute of India, Coonoor, Nilgiris. One month
(Jan’03)
Title: Exposure to various Mammalian Cell Culture Techniques at Sri Raghavendra
Biotechnologies Private Limited, Bangalore.
Duration : One month (Feb’03)
Guide : Dr. S.G.A. Rao
Title: Exposure to various Molecular Biology Techniques like HPLC, FPLC, Flow-Cytometry, SDS-
PAGE, Protein, Sequencing, PCR, RT- PCR and DNA Sequencing. Post Graduate of Medical
Education & Research Center, Chandigarh-160012
Duration : 45 days (June 1st
to July 15).
Guide : Dr.S. Majumdar.
:
MANAGERIAL SKILS
Ability to work independently with minimal supervision and attain group goals Strong
organizational and interpersonal skills, including the ability to prioritize workload Possesses the
ability to deal effectively with a variety of personnel and executive leadership Manage and mentor
teams to achieve organization and individual goals.
HOBBIES:
Sports & Games, Reading Books, Gardening
Social Interaction
PERSONAL PROFILE :
Father’s Name : Satyanarayana.P
Sex : Male
Date of Birth : 09-April-1979
Matrial Status : Married
Language : Telugu, English, Hindi
E-mail id : mohansatyap@gmail.com
Permanent Address : sitharamanagar, door no 8-20-28/37, Guntur-1
Contact No. : 8143912045/9502163050
REFERENCES
1. Dr. B. Parvathi Devi
M.D. Microbiologist,
Director Lab Operations
PathcareLabs
Dr.parvathi@pathcarelabs.com
Ph: 9949998558
2. Dr. Desai Vidya Sripad,
M.D Biochemistry,