Facility Requirements to Initiate the GLP Studyvishnu Jatoth
The document outlines the facility requirements for conducting a GLP study using animals. Key requirements include:
1) The animal research facility must carefully control environmental parameters like temperature, humidity, and light to minimize effects on animals and prevent contact between animals of different studies or with unintended test items.
2) Experimental rooms must be individually ventilated with strict separation of clean and dirty areas, and maintain standards for lighting, noise, and air exchanges.
3) The facility must have provisions for quarantine, housing, feeding, watering, bedding, caging, necropsy, storage, and documentation in accordance with species-specific standards.
4) Detailed standard operating procedures must be maintained and
China, Operation Management of Soil and Fertilizer Testing in ChinaExternalEvents
The document provides an overview of the Soil and Fertilizer Supervision and Testing Center laboratory in Beijing, China. It discusses: 1) an introduction to the laboratory including staff, equipment, certifications, and testing capabilities; 2) China's Soil and Fertilizer Testing Network which the laboratory helps oversee for quality control; and 3) the laboratory's operation management including quality systems, equipment management, sample handling, and quality control procedures.
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.
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.
Presentation ai hce 2017 bob chen updated-3.0Kartik Vora
This document summarizes the results of a study comparing airborne exposure monitoring for surrogates and actual APIs during pharmaceutical manufacturing processes. Personal and static air samples were taken for both a surrogate (mannitol) and an API during various unit operations. Exposures for the API were generally higher than the surrogate, likely due to differences in work practices. The study concluded that while surrogate monitoring can indicate particulate containment effectiveness, it may not accurately represent actual employee API exposures due to variability in properties and work practices. API exposure monitoring is needed to confirm particulate containment and exposure levels. Work practices were found to significantly impact personal exposures and differences between surrogate and API results.
Melissa Bridgers has over 15 years of experience in quality control and microbiology. She currently works as a Regional Microbiologist and Quality Control Supervisor at RB Manufacturing, where she supervises laboratories, develops test methods, performs validations, and ensures compliance. Previously she held roles at Covidien, Surmodics Pharmaceuticals, Southern Research Institute, and Vintage Pharmaceuticals, gaining experience in areas such as microbiological testing, environmental monitoring, equipment validation, and GMP compliance. She has a Bachelor of Science degree from Middle Tennessee State University and is an ISO 9001 lead auditor.
Raw materials include all materials used in manufacturing a finished product, whether present in the final product or not. They must meet defined purchase specifications. Key steps in purchasing raw materials include requisition, supplier selection, quotation, order placement, receipt, and payment. Proper storage conditions must be maintained based on product requirements. Vendors are selected and qualified to ensure a consistent supply of materials meeting quality standards. Receipt, storage, and sampling of materials are controlled through standard operating procedures.
Facility Requirements to Initiate the GLP Studyvishnu Jatoth
The document outlines the facility requirements for conducting a GLP study using animals. Key requirements include:
1) The animal research facility must carefully control environmental parameters like temperature, humidity, and light to minimize effects on animals and prevent contact between animals of different studies or with unintended test items.
2) Experimental rooms must be individually ventilated with strict separation of clean and dirty areas, and maintain standards for lighting, noise, and air exchanges.
3) The facility must have provisions for quarantine, housing, feeding, watering, bedding, caging, necropsy, storage, and documentation in accordance with species-specific standards.
4) Detailed standard operating procedures must be maintained and
China, Operation Management of Soil and Fertilizer Testing in ChinaExternalEvents
The document provides an overview of the Soil and Fertilizer Supervision and Testing Center laboratory in Beijing, China. It discusses: 1) an introduction to the laboratory including staff, equipment, certifications, and testing capabilities; 2) China's Soil and Fertilizer Testing Network which the laboratory helps oversee for quality control; and 3) the laboratory's operation management including quality systems, equipment management, sample handling, and quality control procedures.
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.
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.
Presentation ai hce 2017 bob chen updated-3.0Kartik Vora
This document summarizes the results of a study comparing airborne exposure monitoring for surrogates and actual APIs during pharmaceutical manufacturing processes. Personal and static air samples were taken for both a surrogate (mannitol) and an API during various unit operations. Exposures for the API were generally higher than the surrogate, likely due to differences in work practices. The study concluded that while surrogate monitoring can indicate particulate containment effectiveness, it may not accurately represent actual employee API exposures due to variability in properties and work practices. API exposure monitoring is needed to confirm particulate containment and exposure levels. Work practices were found to significantly impact personal exposures and differences between surrogate and API results.
Melissa Bridgers has over 15 years of experience in quality control and microbiology. She currently works as a Regional Microbiologist and Quality Control Supervisor at RB Manufacturing, where she supervises laboratories, develops test methods, performs validations, and ensures compliance. Previously she held roles at Covidien, Surmodics Pharmaceuticals, Southern Research Institute, and Vintage Pharmaceuticals, gaining experience in areas such as microbiological testing, environmental monitoring, equipment validation, and GMP compliance. She has a Bachelor of Science degree from Middle Tennessee State University and is an ISO 9001 lead auditor.
Raw materials include all materials used in manufacturing a finished product, whether present in the final product or not. They must meet defined purchase specifications. Key steps in purchasing raw materials include requisition, supplier selection, quotation, order placement, receipt, and payment. Proper storage conditions must be maintained based on product requirements. Vendors are selected and qualified to ensure a consistent supply of materials meeting quality standards. Receipt, storage, and sampling of materials are controlled through standard operating procedures.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
The State Laboratory supports national food and feed safety programs through its analysis of animal feedingstuffs and foods. In 2015, the Laboratory tested animal feed samples to ensure compliance with regulations on nutrients, contaminants, and veterinary drug residues. It also analyzed food samples for veterinary drug residues and contaminants as part of Ireland's food safety monitoring plans. New methods were developed to test for additional compounds in feed and food, and the Laboratory's accreditation and testing capabilities were expanded.
This document discusses Good Laboratory Practices (GLP) for quality control laboratories. It defines GLP as a quality system for non-clinical health and environmental safety studies. The purpose of GLP is to promote valid and quality test data for determining safety. Key aspects of GLP include infrastructure requirements for different laboratory sections, calibration and validation of equipment, documentation standards, training programs, and safety measures. The document also provides checklists to ensure all GLP requirements are properly implemented and maintained in the quality control laboratory.
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
This document outlines the process for sampling, testing, and releasing or rejecting packing materials. It describes how quality control receives notification of incoming materials and assigns a sampling executive to verify details and sample containers according to a sampling plan table. The executive records sampling observations and notifies others if issues arise. Samples are tested according to standard procedures and recorded, and status labels of approval or rejection are affixed to containers before the material receipt report and analysis certificate are sent to the warehouse. Primary packing materials undergo complete analysis for each lot while secondary materials have a reduced testing plan.
CSSD Basics Chemical Indicators, Biological Indicators and Recall ProcessPaul Kam
Chemical indicators are devices used to monitor the sterilization process. They are designed to respond with a chemical or physical change to parameters like temperature, pressure, and moisture. There are six classes of indicators that respond to different numbers of sterilization parameters and are used for different monitoring purposes, from basic exposure monitoring to comprehensive cycle verification. Facilities should have policies and procedures established for conducting recalls of sterilized items in the event that indicators show a sterilization failure, to ensure patient safety. The policies should outline the circumstances requiring a recall, who can initiate one, and how to execute, report on, and document a recall to maintain compliance.
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 discusses the validation of critical utility systems used in pharmaceutical manufacturing facilities. It covers the validation of HVAC systems, water systems, steam systems, compressed air systems, and nitrogen gas systems. For each system, it provides an overview and discusses the user requirements, design qualification, installation qualification, operational qualification, and performance qualification protocols. The validation aims to ensure these utility systems meet quality standards and specifications to support the manufacturing of safe and effective pharmaceutical products.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
Site Master File (SMF) is a document, which give a complete and factual information regarding a site of a pharmaceutical manufacturing plant.
• The Document should not be very massive and at the same time it should be not be very brief.
KRS Global Biotechnology is a leading outsourcing facility that provides the highest quality sterile and non-sterile pharmaceutical preparations. It has an unrivaled quality assurance program focusing on cGMP and USP standards. KRS is committed to developing quality processes and safety for patients through services like sterile injectables, intravenous admixtures, and topical preparations. It has a state-of-the-art analytical laboratory and uses advanced equipment to test all injectable products for sterility, potency, pH, and endotoxins to ensure the highest standards of safety and effectiveness for patients.
The document discusses good practices for quality control laboratories, including maintaining an archive of specifications, proper handling and labeling of reagents, calibration and validation of equipment, and ensuring traceability of measurement procedures and reference materials. Specifications must be kept in the latest version and updates tracked. Reagents require clear labeling with details like contents, supplier, date, and concentration. Equipment needs regular calibration and verification according to standard operating procedures, with records kept of maintenance and repairs. Reference materials need to be uniquely identified and stored according to any special conditions. Traceability of measurement procedures and reference materials must be established.
Micheline Winsett has over 15 years of experience in reagent production and microbiology laboratory work. She is currently a Reagent Scientist II at Viracor IBT where she prepares reagents and maintains inventory. Previously, she worked at Aptuit and Quintiles as a Microbiology Associate-Scientist and Technician performing tasks like environmental monitoring, sterility testing, and media preparation in cGMP facilities. She also has experience at Lab One as a Clinical Support Operator and Microbiology Technician.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
The candidate seeks to join a company where they can further develop their chemistry skills and grow as an analyst. They have a B.S. in Biological Sciences and over 7 years of experience performing analytical testing such as HPLC, GC, wet chemistry, and component testing in compliance with various compendia. Their skills include proficiency with various laboratory instruments and certifications in OSHA and safety training.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
Siva Prasad is seeking a position in QA/QC for sterile formulations. He has over 10 years of experience in microbiology working for several pharmaceutical companies. His experience includes conducting microbiological testing, cleaning validations, document control, and training personnel on cGMP guidelines. He is proficient in microbiological methods and validation activities for sterile drug manufacturing facilities.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP is an FDA regulation that provides a framework for planning, conducting, monitoring, recording, and reporting nonclinical laboratory studies. The document outlines the history of GLP and why it was created, describes key aspects of GLP such as organization, personnel, facilities, equipment, test systems, and record keeping. It also discusses objectives of GLP and highlights an important example of a lab that was found to be fraudulent and engaged in poor practices.
This document is a curriculum vitae for K.Siva Prasad that outlines his work experience, skills, and education. It summarizes that he has over 10 years of experience working in quality control and microbiology roles for several pharmaceutical companies. His responsibilities have included microbiological testing, documentation activities, validation activities, and ensuring compliance with cGMP, EU, ICH, and USP guidelines. He holds an M.Sc. in Microbiology and a B.Sc. in Microbiology.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
The State Laboratory supports national food and feed safety programs through its analysis of animal feedingstuffs and foods. In 2015, the Laboratory tested animal feed samples to ensure compliance with regulations on nutrients, contaminants, and veterinary drug residues. It also analyzed food samples for veterinary drug residues and contaminants as part of Ireland's food safety monitoring plans. New methods were developed to test for additional compounds in feed and food, and the Laboratory's accreditation and testing capabilities were expanded.
This document discusses Good Laboratory Practices (GLP) for quality control laboratories. It defines GLP as a quality system for non-clinical health and environmental safety studies. The purpose of GLP is to promote valid and quality test data for determining safety. Key aspects of GLP include infrastructure requirements for different laboratory sections, calibration and validation of equipment, documentation standards, training programs, and safety measures. The document also provides checklists to ensure all GLP requirements are properly implemented and maintained in the quality control laboratory.
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
This document outlines the process for sampling, testing, and releasing or rejecting packing materials. It describes how quality control receives notification of incoming materials and assigns a sampling executive to verify details and sample containers according to a sampling plan table. The executive records sampling observations and notifies others if issues arise. Samples are tested according to standard procedures and recorded, and status labels of approval or rejection are affixed to containers before the material receipt report and analysis certificate are sent to the warehouse. Primary packing materials undergo complete analysis for each lot while secondary materials have a reduced testing plan.
CSSD Basics Chemical Indicators, Biological Indicators and Recall ProcessPaul Kam
Chemical indicators are devices used to monitor the sterilization process. They are designed to respond with a chemical or physical change to parameters like temperature, pressure, and moisture. There are six classes of indicators that respond to different numbers of sterilization parameters and are used for different monitoring purposes, from basic exposure monitoring to comprehensive cycle verification. Facilities should have policies and procedures established for conducting recalls of sterilized items in the event that indicators show a sterilization failure, to ensure patient safety. The policies should outline the circumstances requiring a recall, who can initiate one, and how to execute, report on, and document a recall to maintain compliance.
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 discusses the validation of critical utility systems used in pharmaceutical manufacturing facilities. It covers the validation of HVAC systems, water systems, steam systems, compressed air systems, and nitrogen gas systems. For each system, it provides an overview and discusses the user requirements, design qualification, installation qualification, operational qualification, and performance qualification protocols. The validation aims to ensure these utility systems meet quality standards and specifications to support the manufacturing of safe and effective pharmaceutical products.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
Site Master File (SMF) is a document, which give a complete and factual information regarding a site of a pharmaceutical manufacturing plant.
• The Document should not be very massive and at the same time it should be not be very brief.
KRS Global Biotechnology is a leading outsourcing facility that provides the highest quality sterile and non-sterile pharmaceutical preparations. It has an unrivaled quality assurance program focusing on cGMP and USP standards. KRS is committed to developing quality processes and safety for patients through services like sterile injectables, intravenous admixtures, and topical preparations. It has a state-of-the-art analytical laboratory and uses advanced equipment to test all injectable products for sterility, potency, pH, and endotoxins to ensure the highest standards of safety and effectiveness for patients.
The document discusses good practices for quality control laboratories, including maintaining an archive of specifications, proper handling and labeling of reagents, calibration and validation of equipment, and ensuring traceability of measurement procedures and reference materials. Specifications must be kept in the latest version and updates tracked. Reagents require clear labeling with details like contents, supplier, date, and concentration. Equipment needs regular calibration and verification according to standard operating procedures, with records kept of maintenance and repairs. Reference materials need to be uniquely identified and stored according to any special conditions. Traceability of measurement procedures and reference materials must be established.
Micheline Winsett has over 15 years of experience in reagent production and microbiology laboratory work. She is currently a Reagent Scientist II at Viracor IBT where she prepares reagents and maintains inventory. Previously, she worked at Aptuit and Quintiles as a Microbiology Associate-Scientist and Technician performing tasks like environmental monitoring, sterility testing, and media preparation in cGMP facilities. She also has experience at Lab One as a Clinical Support Operator and Microbiology Technician.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
The candidate seeks to join a company where they can further develop their chemistry skills and grow as an analyst. They have a B.S. in Biological Sciences and over 7 years of experience performing analytical testing such as HPLC, GC, wet chemistry, and component testing in compliance with various compendia. Their skills include proficiency with various laboratory instruments and certifications in OSHA and safety training.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.
It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.
Siva Prasad is seeking a position in QA/QC for sterile formulations. He has over 10 years of experience in microbiology working for several pharmaceutical companies. His experience includes conducting microbiological testing, cleaning validations, document control, and training personnel on cGMP guidelines. He is proficient in microbiological methods and validation activities for sterile drug manufacturing facilities.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP is an FDA regulation that provides a framework for planning, conducting, monitoring, recording, and reporting nonclinical laboratory studies. The document outlines the history of GLP and why it was created, describes key aspects of GLP such as organization, personnel, facilities, equipment, test systems, and record keeping. It also discusses objectives of GLP and highlights an important example of a lab that was found to be fraudulent and engaged in poor practices.
This document is a curriculum vitae for K.Siva Prasad that outlines his work experience, skills, and education. It summarizes that he has over 10 years of experience working in quality control and microbiology roles for several pharmaceutical companies. His responsibilities have included microbiological testing, documentation activities, validation activities, and ensuring compliance with cGMP, EU, ICH, and USP guidelines. He holds an M.Sc. in Microbiology and a B.Sc. in Microbiology.
Ajay Kumar Sharma's resume summarizes his academic qualifications and extensive experience in quality assurance and laboratory management. He holds an M.Phil. and M.Sc. in Microbiology and has worked in roles such as Quality Manager, Laboratory Coordinator, and Government Analyst at two organizations for over 14 years. His responsibilities have included implementing quality management systems, conducting microbiological and chemical analyses, supervising laboratory operations, and ensuring compliance with various accreditation standards.
Patience Kache Chula is a medical technologist with over 12 years of experience in clinical laboratories. She has a Higher National Diploma in Medical Laboratory Technology from The Kenya Polytechnic and is certified by the Kenya Medical Laboratory Technicians and Technologists Board. Currently she works as a consultant laboratory mentor assisting laboratories in attaining accreditation. Previously she has held positions as a laboratory manager, quality assurance officer, and laboratory technologist.
This document provides a summary of an individual's experience in analytical chemistry and quality control/assurance roles in the pharmaceutical industry spanning over 25 years. The summary highlights experience developing analytical methods, managing chemistry departments, training personnel, and ensuring compliance with cGMP and other regulatory requirements. Managerial experience is also summarized.
This document provides a summary of an individual's experience in analytical chemistry and quality control/assurance roles in the pharmaceutical industry spanning over 25 years. It highlights experience developing analytical methods, managing chemistry departments, training personnel, and ensuring compliance with cGMP and other regulatory requirements. Managerial experience includes leading teams, budgets, and vendor management. Technical skills include chromatographic and other analytical techniques.
- The candidate has over 2 years of experience as a Quality Controller in the mineral water industry in UAE and over 1 year of experience in mammalian cell culture upstream activities in India.
- He has experience establishing and maintaining quality management documentation systems, conducting internal/third party audits and trainings, and performing chemical and microbiological analysis of water.
- He is experienced operating various types of bioreactors and maintaining cell culture processes, and has skills in instrumentation like bioreactors, spectrophotometers, and cell counting tools.
1. Amr Zaki Khamis provides his personal and contact information, including his name, date of birth, address, phone number, email, nationality, and marital status.
2. He lists his education as a B.Sc. in Chemistry from Helwan University in 2004 and over 11 years of work experience in quality control roles.
3. His experiences include positions as a quality control engineer, head of quality control labs, and quality management system consultant for several companies between 2004-2016.
Amir Hameed is seeking a challenging position in quality assurance where he can continue developing his skills. He has over 10 years of experience in quality control roles at dairy and ice cream plants. His responsibilities included comprehensive quality testing, ensuring standards compliance, staff training, and continuous quality improvement initiatives. He has certifications in food technology and safety training, and holds a DAE in Food Technology.
The Ambo plant protection Research Center renovated and rearranged several of its plant protection laboratories in preparation for ISO 17025 accreditation. Key activities included removing non-functional equipment, reorganizing laboratory rooms and equipment, hiring and training new staff, and validating test methods. Challenges included lack of initial ISO awareness, staff turnover, and restricted access to certified reference materials for proficiency testing. Opportunities exist to provide continued training and establish robust ISO systems across research centers. Future plans include expanding diagnostic testing capabilities and supporting laboratory staff development.
Item 8: Global Soil Laboratory Network (GLOSOLAN)Soils FAO-GSP
The Global Soil Laboratory Network (GLOSOLAN) works to harmonize soil laboratory methods and build analytical capacity. It operates through 6 regional networks encompassing over 360 laboratories worldwide. In 2019-2020, GLOSOLAN made several achievements, including participating 100 laboratories in a proficiency test, publishing the first 5 standard operating procedures, establishing an equipment bartering system, and launching initiatives on spectroscopy and fertilizer quality assessment. Going forward, GLOSOLAN aims to further promote proficiency testing, training, and the development of harmonized methods.
The document outlines the quality policy and objectives of the Ethiopian Institute of Agricultural Research (EIAR). It states that EIAR is committed to third party accreditation according to ISO/IEC 17025 standards for selected laboratories. The Director General supports this quality policy and laboratories must demonstrate compliance through independent accreditation. Each laboratory head is responsible for fulfilling quality requirements. The quality director must ensure staff understands the quality system and the importance of meeting customer and regulatory requirements through continual improvement.
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.
Mr. Chebli has over 10 years of experience in quality control laboratories for pharmaceutical companies. He currently works as the Quality Control Laboratory Manager at Laboratoires SALEM in Algeria where he oversees laboratory operations, ensures compliance with GLP and GMP standards, manages analytical methods and product testing, and guides laboratory staff. Prior to his current role, he worked as a Quality Control Analyst at Laboratoires SALEM where he performed analytical testing, participated in inspections and investigations, and maintained laboratory equipment and inventory. He holds an engineering degree in Pharmaceutical Processes and additional qualifications in chemistry, microbiology, and technical English.
The document is a curriculum vitae for S. Kalithas seeking a quality control or quality assurance role in the pharmaceutical or FMCG sector. It summarizes his over 10 years of experience in pharmaceutical quality control, including his current role as Deputy Manager of Quality Control at Biocon Ltd since 2008 where he manages a team of 8 members and oversees analytical work, documentation, and ensuring compliance. It also lists his educational qualifications including an MSc in Chemistry from Madurai Kamaraj University in 2003.
The document provides details about an internship completed by Aafreen Salim at the Food Analysis Laboratory of Vardan Envirolab from February 20th to May 20th, 2023. It includes an acknowledgment, introduction to the laboratory, details of the management team and various departments. Standard operating procedures for proximate analysis methods like moisture, ash, protein, fat, carbohydrate, energy and dietary fiber determination are also outlined.
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.
- Sunil Kumar Singh has over 15 years of experience in analytical chemistry and quality control roles at various agrochemical and pharmaceutical companies.
- He is currently an Assistant Manager at Nagarjuna Agrichem Limited, where he manages analytical testing and develops new methods to analyze raw materials and products.
- Previously he has held roles such as Senior Research Scientist and Study Director, where he ensured compliance with GLP standards and oversaw the conduct of studies.
- He has a B.Sc. and M.Sc. in Chemistry and is proficient in the operation of analytical instruments like GC, HPLC, GC-MS and their use in method development and validation.
Similar to Turkey: Soil Fertilizer and Water Resources, Central Research Institute (20)
Global Soil Partnership efforts to promote soil governance from the global to...Soils FAO-GSP
Webinar on soil governance and launch of SoiLEX
13 January 2021 | 15:00 to 16:30 CET online (Zoom platform).
Mr Hugo Bourhis, International Consultant, FAO GSP
The importance of Soil Awareness for developing Soil Protection LawSoils FAO-GSP
Webinar on soil governance and launch of SoiLEX
13 January 2021 | 15:00 to 16:30 CET online (Zoom platform).
Dr Irene Heuser, Chair, Specialist Group on Soil, Desertification and Sustainable Agriculture, IUCN World Commission on Environmental Law
Good Governance for sustainable soil management: How to do it? Soils FAO-GSP
Webinar on soil governance and launch of SoiLEX
13 January 2021 | 15:00 to 16:30 CET online (Zoom platform).
Dr Harald Ginzky, Lawyer of Umweltbundesamt, Germany
The status of salt-affected soils in Eurasia with a focus on UzbekistanSoils FAO-GSP
The document discusses salt-affected soils in the Eurasian region, with a focus on Uzbekistan. Salt-affected soils are a major problem for agriculture and food security, affecting over 40% of irrigated croplands in Central Asia. In Uzbekistan, approximately 48% of irrigated lands are salt-affected, causing annual losses of $31 million. Recent government programs aim to improve irrigation systems and rehabilitate over 1 million hectares of degraded land through measures like deep ripping, crop diversification, and afforestation. International organizations have invested over $1 billion in water and agriculture projects to address land and water management issues in Uzbekistan.
The status of salt-affected soils in NENA with a focus on IraqSoils FAO-GSP
The document discusses the problem of soil salinity in Iraq. It notes that 60-70% of land in central and southern Iraq is affected by salinity, which is the main limiting factor for agricultural production. The document outlines the types of salinity found in Iraq, potential reclamation costs, and previous and proposed strategies to address soil salinity, including leaching of soils, use of saline-tolerant crops, and national strategies around water resource management and soil treatment.
Introduction to the International Network of Salt-Affected Soils and update o...Soils FAO-GSP
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Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
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Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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Turkey: Soil Fertilizer and Water Resources, Central Research Institute
1. First Meeting of the Regional Soil Laboratory Network
for Eurasia and Europe
National Reference Laboratories
Quality Control, Quality Assurance and Good
Laboratory Practices
3. The Institute was established in
1954, in Ankara as a National
Specialization Institute under
General Directorate of Agricultural
Affairs.
After the Institute was converted to
Central Research Institution by the
approval of the Ministry in 2007,
renamed as Soil Fertilizer and Water
Resources Central Research
Institute.
HISTORY OF THE INSTITUTE
4. Our mission; is to carry out and conclude high quality researches that can
satisfy the demands of Turkish agricultural sector in the area of soil, fertilizer
and water resources and also support the Ministry both in national and
international levels in terms of research and policymaking through
concentrating on some activities like in-service trainings, seminars and
courses.
Our vision; is to produce data for the needs of the Ministry on an
institutional basis, to carry out national and international research studies,
and to assist solving the problems which the sector may encounter through
the increasing quality of institutional R&D capacity.
Task Description; to make a contribution to making and initiating policies
that consider human and environmental conditions through recommending
necessary advice based on internationally standardized research studies in
the area of soil, fertilizer and water resources.
MISSION and VISION
5. Laboratory Quality Management has been started to work with the
purpose of establishing quality consciousness and ensuring continuity in
controlled work in the Institute.
Having laboratories accepted by the Ministry for reference in soil water
and plant analyzes, the Institute has been accredited in NPK analyses on
chemical fertilizers according to TS EN ISO/IEC 17025 "General
Requirements for Qualification of Testing and Calibration Laboratories"
standard in 2010.
TOTAL QUALITY MANAGEMENT SYSTEM
TS EN ISO/IEC 17025
6. It is the first laboratory in the Ministry of Agriculture and Forestry that is
accredited with regards to chemical fertilizers. The Institute has been
accredited in all laboratories on October 9, 2014. Institute's laboratories
were accredited in 39 methods by 2019.
TOTAL QUALITY MANAGEMENT SYSTEM
TS EN ISO/IEC 17025
7. TOTAL QUALITY MANAGEMENT SYSTEM
In 2017 the Institute was authorized within
the scope of the circular "Establishment
Authority and Inspection Circular of
Agricultural, Soil, Plant and Irrigation Water
Analysis Laboratories for Agricultural
Purposes" and Proficiency Test Cycle has been
started to be organized Proficiency Test twice
a year in accordance with the "TS EN ISO/IEC
17043 Conformity Assessment and General
Conditions for Proficiency Test".
In 2018, the Institute has been accredited by
TURKAK according to ISO EN/IEC 17043.
TS EN ISO/IEC 17043
8. TOTAL QUALITY MANAGEMENT SYSTEM
INTERNAL CONTROL SYSTEM
Since 2011, with the Internal Control System has defined the
functioning of all sub-units, organizational charts, processes,
activities carried out, job description and requirements
documents, work flow charts, risks, control strategies,
information and communication processes, monitoring and
evaluation mechanisms.
It is aimed to carry out all activities carried out by the Institute in
a correct, fast, effective, efficient and frugal manner with the
understanding of searching, improving and developing the
quality continuously.
9. EFQM (European Foundation for Quality Management)
Excellence Model was adopted to the Institute in 2013 in
order to have international standards in all units.
Thus, by adopting a modern management approach that
takes into account the needs and satisfaction of all
stakeholders, it adopted the "EFQM Excellence Model" as a
role model.
A team from Turkish Quality Association has made their on-
site assessment and the Institute has risen to the level of
"EFQM Recognised For Excellence 4 Star" in the process
and was included the “Global Excellence Index” organization
by the EFQM in 2018.
TOTAL QUALITY MANAGEMENT SYSTEM
EFQM
10. The Institute's Total Quality Management System was created in
2013 to ensure an effective coordination among the Quality
Management, Internal Control System and EFQM Excellence Model
and the system is responsible for ensuring that quality
understanding is settled in all departments and units of the
Institute.
TOTAL QUALITY MANAGEMENT SYSTEM
11. There are 6 different subject oriented laboratories in the Institute
• Plant and Organic Fertilizer Analysis Laboratory
• Microbial Fertilizer R&D and Culture Collection Center
• Soil Quality and Fertility Analysis Laboratory
• Chemical Fertilizer Laboratory
• Irrigation Water Quality Analysis Laboratory
• Irrigation, Soil Physics and Salinity Laboratory
LABORATORIES
12. LABORATORY ACTIVITIES
→ To authorize and inspect laboratories belonging to the public and
private sector which were authorized by The Ministry of Agriculture and
Forestry,
→ To analyze soil, fertilizer and water analyses and to give necessary
advice at international standards within quality assurance,
→ To carry out quality control and standardization of soil analyses
To inspect markets according to "Chemical and Organic Fertilizer Control
Regulation«,
→ To carry out training on laboratory studies nation-wide.
13. 200.000 analysis capacity for 15.000 samples in a year
10.000 soil fertility parameters analysis capacity for 1.000 soil samples
in a month
3.000 soil salinity analysis capacity for at least 200 soil samples in a
month
500 soil physical properties analysis capacity for 100 soil samples in a
month
500 analysis capacity for 100 liquid and solid fertilizers in a month
1.500 analysis capacity for 150 organic materials in a month
5.000 water quality analysis capacity for 500 samples in a month
LABORATORY CAPACITY
14. QC/QA
Quality Assurance (QA) is a proactive quality process. Quality Control (QC),
on the other hand, focuses on finding defects in the product claimed to be
completed. Therefore, Quality Control (QC) is a reactive quality process.
15. STAFF
We have procedure and retain records for selection, training,
supervision, authorization, monitoring competence of personnel.
Laboratory personnel are authorized to development, modification,
verification/validation of methods; analysis, report, review and
authorization of results.
16. FACILITIES AND ENVIRONMENTAL CONDITIONS
Our facilities and environmental conditions are suitable for
laboratory activities and not adversely affect the validity of results.
We monitor, control, record environmental conditions where they
influence the validity of the results.
Access to and use of areas affecting laboratory activities, prevention
of contamination, interference, effective separation between areas
with incompatible laboratory activities are monitored and
periodically reviewed.
17. EQUIPMENT
→ The equipment used for measurement is capable of achieving the
measurement uncertainty required to provide a valid result.
→ We calibrate equipment;
• When the measurement accuracy or measurement uncertainty affected
the validity of the reported results
• For establishing the metrological traceability of the reported results
→ The laboratory establishes a calibration programme
→ All equipment requiring calibration are labelled/coded
→ All calibrated equipment have a intermadiate check program
18. METROLOGICAL TRACEABILITY
Metrological traceability is defined as “the property of a measurement
result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the
measurement uncertainty”.
We establish and maintain metrological traceability of results by;
• Calibration provided by acredited laboratory,
• Using certified reference materials provided by acredited producer.
19. SELECTION, VERIFICATION / VALIDATION OF METHODS
→ We use appropriate methods and procedures for all laboratories.
→ All methods and supporting documentation be kept up to date.
→ We verifying properly perform methods before introducing.
20. USE OF REFERENCE MATERIALS OR QUALITY CONTROL MATERIALS
(QC CHARTS)
The method is in control if:
• The control value is within the warning
limits
• The control value is between warning
and action limit and the two previous
control values were within warning
limits
The method is out of control if:
• The control value is outside the action
limits
• Seven control values in consecutive
order gradually increase or decrease
• The control value is between the
warning and the action limit and at
least one of the two previous control
values is also between warning and
action limit
Range-charts
X – charts
21. PARTICIPATION IN PROFICIENCY TESTING AND IN
INTERLABORATORY COMPARISONS OTHER THAN PROFICIENCY
TESTING
The Institute should participate in a Proficiency Test within 48 months
period at least.
22. ALSO, WE ASSURING THE QUALITY OF THE LABORATORY
RESULTS WITH;
• Actions to address risks and opportunities,
• Improvement,
• Corrective actions,
• Internal audits (at least within 12 months period),
• Management reviews (at least within 12 months period)
• Retesting of items
• Correlation of results for different characteristics of an item
• Review of reported results
• Ensuring externally provided products and services confirm to
the laboratory’s established requirements before they are used
Hello everyone and welcome. I am glad to be here with Eurosolan members today.
I'd like to start quickly introduce myself. I am Yasemin Demir from Soil Fertilizer and Water Resources Central Research Insitute. I have been working for eight years in there and also last one year as Quality Manager for Proficiency Testing. I will make a presentation about my Institute, Quality Assurance and Quality Control.
The Institute has been operating since 1954 under the Ministry of Agriculture and Forestry. This is today's name of Ministry.
This slide shows the our mission, vision and tasks. These are official and long descriptions. So I don't want to read all of them but shortly we are working for improving Turkey's agriculture R-D capacity.
Laboratory Quality Management has been started to work in 2007. After 3 years that we had accreditation for NPK analysis firstly.
Then we continued working about Quality management. Today we have accreditation for 39 methods according to ISO 17025.
Also, we are organizing Proficiency Tests twice a year since 2017. The Institute has been accredited according to ISO 17043 last year.
We have also Internal Control System in the institute. We defined the functioning of all sub-units, processes, risks etc. Thus, we aim to carry out all activities with the understanding of correct, fast, effective and continuous improvement and development.
EFQM was adopted to the Institute six years ago in order to have international standards in all units. Then we had a new role model EFQM. After that we had 4 Star in the process and accepted to the Global Excellence Index last year.
We needed total quality management. Because we wanted to to put these system under a roof. So, we have total quality management in the institute for 6 years. We aimed that ensure an effective coordination among the Quality Management, Internal Control System and EFQM Excellence Model.
Our Institute has 6 laboratories. You see their topics on the slide.
Our team is working in the laboratories for the purpose of to authorize and inspect laboratories which were authorized by our Ministry and to analyze soil, fertilizer and water analyses and to give advice. Also, they making quality control and standardization of soil analyses, to inspect markets. And they organizing training in laboratory studies.
We have realy large capacity of laboratories in Turkey. In total, we have 200.000 analysis capacity for 15.000 samples in a year.
Okay as I said before the Institute is an R-D centre and have big laboratories. So Quality management is very important for us. QA is a proactive quality process. QC focuses on finding defects in the product. Therefore, QC is a reactive quality process.
What are we doing about QC/QA? I will try to give some examples. We have a procedure and retain records for selection, training, supervision, authorization, monitoring competence of personnel. Laboratory personnel are authorized to development, modification, verification/validation of methods; analysis, report, review and authorization of results.
We have suitable facilities for laboratory activities and we are controlling, monitoring and recording our environmental conditions regularly. There is an effective separation between areas with incompatible laboratory activities are monitored and periodically reviewed.
About the equipment.
We are testing our laboratories through proficiency tests. The Institute should participate in a Proficiency Test within 48 months period at least. You see the number of proficiency tests that we participated on the slide.
That's all I'm talking about. Thank you for attention.