Quality Assurance Services
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GVK Biosciences (GVK BIO) Clinical Research division has an independent Quality Assurance (QA) unit which conducts audits of services of all business lines within the division on a routine basis to ensure delivery of quality services. The Clinical Research QA staff report to the Director-QA, GVK BIO who in turn reports to the CEO of GVK BIO
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A presentation about Compliance Insight Inc and our services. For more information go to http://compliance-insight.com/about-us/
Concept & evolution of qa & qc
QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
QA vs QC by Dr.A S Charan
Quality assurance
Quality control
GMP
Pharmaceutical industry
Pharmaceutical Analysis
Pharmaceutical analyst
Strategies of assuring quality of laboratory results
The document discusses strategies for assuring the quality of laboratory results. It covers quality assurance procedures such as quality control, quality assessment, laboratory standardization, and method validation. The key components of quality assurance include quality control, which uses techniques like analysis of reference materials and proficiency testing. Quality assessment involves periodic external evaluation to monitor and improve laboratory performance. Together, effective quality control and assessment help laboratories consistently produce accurate and reliable test results.
Shashidhar kaza cv
This candidate has over 9 years of experience in quality control and assurance for vaccines and pediatric food products. Their skills include microbiological analysis, audits, biochemical analysis, and validation studies. They are proficient in techniques such as ELISA testing, sterility testing, and microbiological identification. They have a successful track record of implementing quality standards and process improvements to optimize efficiency and product quality.
CV_Clin_Reshma 24 Jan 17
Worked as a Clinical QA auditor and quality reviewer for clinical trials from Phase I to Phase IV in various therapeutic areas, including biosimilars. Performed audit activities such as preparing audit plans, conducting onsite and remote audits, and reviewing audit reports. Also performed quality reviews of clinical documents to ensure compliance with regulations and guidelines. Currently working as Manager, Clinical Quality Assurance at Dr. Reddy's Laboratories in Hyderabad.
Quality assurance and quality control B.Pharm.
The document defines quality, quality control, and quality assurance in the pharmaceutical industry. It states that quality control is corrective and focuses on identifying defects in finished products, while quality assurance is preventative and focuses on ensuring quality is built into the development and manufacturing processes. The responsibilities of the quality control and quality assurance departments are also outlined, with quality control responsible for testing and release of products and quality assurance responsible for monitoring, auditing and ensuring compliance with quality standards.
good laboratory practices.pptx
The document discusses key concepts related to good laboratory practices including Good Manufacturing Practice (GLP), Good Laboratory Practice (GLP), the US FDA rules for GLP, OECD Guidelines for the Testing of Chemicals, ISO 9000 quality management standards, total quality management (TQM), quality review and documentation, validations, and process validation. GLP and ISO 9000 establish standards and guidelines to ensure uniformity, consistency, reliability, and quality in laboratory studies and testing. The US FDA and OECD provide specific rules and guidelines for GLP compliance. Validations are required to demonstrate equipment, facilities, and processes operate as intended to maintain compliance.
Cro perspectives
The document provides information about audits, inspections, and compliance from the perspective of a Contract Research Organization (CRO). It discusses what a CRO is and different types of CROs. It outlines the importance of having a structured compliance plan and ensuring compliance with Good Laboratory/Clinical/Manufacturing Practices, applicable rules, regulations, and guidelines. The document emphasizes that quality control, monitoring, auditing, and inspections are necessary to ensure compliance and pass regulatory inspections. It provides tips for sites on preparing for and handling inspections by regulatory authorities like the FDA.
Qa in ba be
This document discusses quality assurance in bioavailability and bioequivalence studies. It outlines key elements of quality management including adherence to standards, prevention of errors, independent assessment of compliance, and having a flexible system. It also discusses Good Clinical Practice, Good Laboratory Practice, and the role of quality assurance in ensuring compliance with regulations and standards. Quality assurance aims to ensure credibility and accuracy of data through audits and monitoring.
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Good Laboratroy Practices for Pharmaceutical Laboratory.pptx
Good Laboratroy Practices for Pharmaceutical Laboratory.pptx
Strategies of assuring quality of laboratory results
Strategies of assuring quality of laboratory results
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GVK BIO Corporate Brochure 2017
GVK BIO is one of the largest India-based Discovery, Development and Manufacturing solutions provider to the Biopharma industry. GVK BIO provides a continuum of Drug
Discovery solutions from pre-Hit to candidate
selection. Our expertise spans across
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PK Services
GVK BIO vivarium is AAALAC certified and registered with CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), Government of India.
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At GVK BIO, seamless integration of life sciences expertise with information technology helps bring database products and services to accelerate your research from discovery to development.
Clinical METadata
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GVK Biosciences (GVK BIO) offers screening services for drug discovery to determine biological activity and properties customized to meet the research needs of the Pharma and Biotech industries. Our range of assays include Biochemical, Cellular, ADME assays & Animal models for profiling of NCEs for Potency, Selectivity, Efficacy, Drugability and Toxicity.
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This document lists 14 intermediates used in pharmaceutical manufacturing along with their CAS numbers. The intermediates include carvedilol, ezetimibe, fluvastatin sodium, lamotrigine, lansoprazole, montelukast sodium, and zoipidem hemitartrate. Information provided includes the name of each intermediate, its corresponding CAS number, and in some cases additional chemical identifiers. The intermediates support the production of various active pharmaceutical ingredients.
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The managers achieve organizational objectives by getting work from
others and not performing in the tasks themselves.
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Quality Assurance Services
- 1. sd Quality Assurance Services GVK Biosciences (GVK BIO) Clinical Research division has an independent Quality Assurance (QA) unit which The Quality Assurance department coordinates training of clinical research staff to ensure continuous conducts audits of services of all business lines within the division on a routine basis to ensure delivery of improvement and updating of clinical regulations. quality services. The Clinical Research QA staff report to the Director-QA, GVK BIO who in turn reports to the Team Expertise CEO of GVK BIO. In addition to providing routine internal quality assurance support, GVK BIO's QA team The QA team has a combined experience of over 20 years. Director-QA, has vast experience in the also provides auditing services to its clients. development of Quality Systems and handling GCP / GLP audits successfully by various regulatory agencies Following are the types of audits we conduct: like USFDA, WHO (World Health Organization), AFSSAPS (France), Ministry of Health (Turkey), ANVISA • Study specific site audits to ascertain compliance to protocol, GCP and regulatory requirements • Study specific Clinical Operations audits at start up, ongoing and close-out phases of the study • Clinical database audits are conducted before the database is moved to production, interim database audit and database audit before database lock • Biostatistics audits covering quality review of tables, data listings, and study reports (Brazil) and GCP / GLP audits of multinational companies. About GVK BIO GVK Biosciences (GVK BIO) is Asia’s leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Services • Chemistry Services • Project specific medical affairs audits to ensure compliance to protocol, regulatory requirements, client agreements and GCP • Process R&D and Custom Synthesis • Process oriented audits across different functions and business lines within Clinical Research • Clinical Research • Contract audits on behalf of sponsor/ health authorities at the sites • Biology • Informatics • Clinical Pharmacology Contact: bdcrd@gvkbio.com Visit: www.gvkbio.com