A calibration procedure is a controlled document that provides a validated method for evaluating and verifying the essential performance characteristics, specifications, or tolerances for a model of measuring or testing equipment.
This document provides an overview of instrument validation and calibration techniques. It discusses the definitions of calibration and validation, highlighting that calibration demonstrates an instrument produces results within specified limits compared to a reference standard, while validation establishes that an analytical procedure meets requirements for intended use. The need for regular calibration of instruments is explained, including after installation, time periods, shocks, or questionable observations. Methods for calibrating an infrared spectrophotometer are presented, including verifying wave numbers and resolution performance against tolerance limits. Applications of infrared spectroscopy like structure determination and identification are also mentioned.
Calibration - UV VIS Spectrophotometer, HPLC, Gas Chromatograph, IR spectroph...SELINA SRAVANTHI
Calibration of analytical instruments is important to ensure accurate measurements. It involves comparing instruments to more precise reference standards. Calibrating UV-Vis spectrophotometers involves checking wavelength accuracy using holmium filters, absorbance accuracy using potassium dichromate, stray light levels, resolution, and linearity. Calibrating IR spectrometers involves checking wavenumber accuracy using polystyrene, resolution, transmittance levels, linearity, and reproducibility. Calibrating fluorimeters involves setting excitation/emission wavelengths and adjusting the concentration readout using standards. Calibrating HPLCs involves checking flow rate accuracy and gradient performance using solvent mixtures.
This document discusses calibration of UV-Visible spectrophotometry. Calibration is required to ensure accurate measurements and is performed using primary reference standards. Parameters that must be calibrated for UV-Visible spectrophotometry include wavelength, stray light, resolution, control of absorbance, spectral split width, and solvents. The document provides procedures and acceptance criteria for calibrating these parameters using various chemical solutions and measurements of absorbance. Maintaining calibrated instrumentation is important for compliance with regulations and producing reliable results.
IR interpretation and sample handling Afzaye Rasul
The document discusses sample handling and interpretation of infrared spectroscopy. It describes several methods for preparing solid, liquid, and gas samples for IR analysis. These include pressed KBr pellets for solids, liquid samples in thin films between windows, and gases in cells. The document then outlines how to interpret IR spectra by identifying key functional groups like carbonyl, hydroxyl, aromatic, and C=C bands. It provides examples of infrared absorptions for several classes of organic compounds including alkanes, alkenes, alcohols, ketones, and amides.
This document discusses gas chromatography (GC), which separates compounds that can be vaporized without decomposing. It has two types depending on the stationary phase: gas-solid chromatography (GSC) and gas-liquid chromatography (GLC). The distribution of analytes between phases is expressed by the distribution constant K. Plate theory and rate theory, including the Van Deemter equation, are presented to describe column efficiency and factors influencing peak broadening such as eddy diffusion, longitudinal diffusion, and mass transfer under non-equilibrium conditions.
This document provides calibration procedures for various instruments used in pharmaceutical analysis. It describes calibrating a UV-Vis spectrophotometer using holmium perchlorate and potassium dichromate primary standards to control wavelength and absorbance. It also provides procedures to calibrate using potassium chloride and toluene solutions. Regular calibration is important to ensure instruments produce accurate results, and should be performed when time periods elapse, operating hours change, a new instrument is used, or observations seem questionable.
This document provides information on calibrating and qualifying various analytical instruments. It discusses the importance of calibration and qualification to ensure proper functioning and accurate results. It describes the different types of qualification including design, installation, operational and performance qualification. It then provides details on specific calibration procedures for various instruments like electronic balances, pH meters, UV-Vis and IR spectrophotometers, and HPLC. The calibration procedures ensure the instruments meet parameters for accuracy, resolution, wavelength verification and flow rate consistency.
This document provides an overview of instrument validation and calibration techniques. It discusses the definitions of calibration and validation, highlighting that calibration demonstrates an instrument produces results within specified limits compared to a reference standard, while validation establishes that an analytical procedure meets requirements for intended use. The need for regular calibration of instruments is explained, including after installation, time periods, shocks, or questionable observations. Methods for calibrating an infrared spectrophotometer are presented, including verifying wave numbers and resolution performance against tolerance limits. Applications of infrared spectroscopy like structure determination and identification are also mentioned.
Calibration - UV VIS Spectrophotometer, HPLC, Gas Chromatograph, IR spectroph...SELINA SRAVANTHI
Calibration of analytical instruments is important to ensure accurate measurements. It involves comparing instruments to more precise reference standards. Calibrating UV-Vis spectrophotometers involves checking wavelength accuracy using holmium filters, absorbance accuracy using potassium dichromate, stray light levels, resolution, and linearity. Calibrating IR spectrometers involves checking wavenumber accuracy using polystyrene, resolution, transmittance levels, linearity, and reproducibility. Calibrating fluorimeters involves setting excitation/emission wavelengths and adjusting the concentration readout using standards. Calibrating HPLCs involves checking flow rate accuracy and gradient performance using solvent mixtures.
This document discusses calibration of UV-Visible spectrophotometry. Calibration is required to ensure accurate measurements and is performed using primary reference standards. Parameters that must be calibrated for UV-Visible spectrophotometry include wavelength, stray light, resolution, control of absorbance, spectral split width, and solvents. The document provides procedures and acceptance criteria for calibrating these parameters using various chemical solutions and measurements of absorbance. Maintaining calibrated instrumentation is important for compliance with regulations and producing reliable results.
IR interpretation and sample handling Afzaye Rasul
The document discusses sample handling and interpretation of infrared spectroscopy. It describes several methods for preparing solid, liquid, and gas samples for IR analysis. These include pressed KBr pellets for solids, liquid samples in thin films between windows, and gases in cells. The document then outlines how to interpret IR spectra by identifying key functional groups like carbonyl, hydroxyl, aromatic, and C=C bands. It provides examples of infrared absorptions for several classes of organic compounds including alkanes, alkenes, alcohols, ketones, and amides.
This document discusses gas chromatography (GC), which separates compounds that can be vaporized without decomposing. It has two types depending on the stationary phase: gas-solid chromatography (GSC) and gas-liquid chromatography (GLC). The distribution of analytes between phases is expressed by the distribution constant K. Plate theory and rate theory, including the Van Deemter equation, are presented to describe column efficiency and factors influencing peak broadening such as eddy diffusion, longitudinal diffusion, and mass transfer under non-equilibrium conditions.
This document provides calibration procedures for various instruments used in pharmaceutical analysis. It describes calibrating a UV-Vis spectrophotometer using holmium perchlorate and potassium dichromate primary standards to control wavelength and absorbance. It also provides procedures to calibrate using potassium chloride and toluene solutions. Regular calibration is important to ensure instruments produce accurate results, and should be performed when time periods elapse, operating hours change, a new instrument is used, or observations seem questionable.
This document provides information on calibrating and qualifying various analytical instruments. It discusses the importance of calibration and qualification to ensure proper functioning and accurate results. It describes the different types of qualification including design, installation, operational and performance qualification. It then provides details on specific calibration procedures for various instruments like electronic balances, pH meters, UV-Vis and IR spectrophotometers, and HPLC. The calibration procedures ensure the instruments meet parameters for accuracy, resolution, wavelength verification and flow rate consistency.
This document discusses validation parameters for analytical methods according to FDA, USP, and ICH guidelines. It outlines key parameters such as specificity, linearity, accuracy, precision, detection and quantitation limits, ruggedness, and robustness. Precision is discussed as having three levels - repeatability, intermediate precision, and reproducibility. The document also provides details on validation parameters like range, system suitability testing, and acceptance criteria for assays.
This document discusses various topics related to UV-visible spectroscopy including:
1. Choice of solvents and their effects on UV-visible spectra. Polar solvents can cause red or blue shifts in absorption maxima depending on the solute.
2. Applications of UV-visible spectroscopy like quantitative analysis of single and multiple component samples and qualitative analysis through structural elucidation, detection of functional groups, and identification of compounds.
3. Difference spectroscopy, where the difference in absorbance between two samples is measured to improve selectivity in the presence of interfering absorbers.
This document discusses the calibration of various analytical instruments used in pharmaceutical analysis. It begins with an introduction to calibration and the need for calibrating instruments. It then provides details on calibrating UV-Vis spectrophotometers, IR spectrophotometers, spectrofluorimeters, HPTLC, and gas chromatography. For each instrument, it describes the parameters checked during calibration such as wavelength accuracy, resolution, photometric accuracy, linearity, and acceptance criteria. The document aims to explain the calibration process for key analytical tools to ensure accurate measurements.
UV/visible spectroscopy involves measuring the absorption of ultraviolet or visible light by molecules. It utilizes light in the wavelength range of 200-800 nm.
The key components of a UV-visible spectrophotometer are a light source, wavelength selector such as a monochromator, sample holder, detector, and associated electronics. Common light sources include deuterium lamps, tungsten lamps, and mercury lamps. Samples are typically held in quartz or glass cuvettes. Detectors include phototubes and photodiodes.
UV-visible spectroscopy can be used to analyze samples containing multiple components. Methods for multicomponent analysis include simultaneous equations using absorption data at two wavelengths, absorbance ratio methods
This document discusses different types of chromatography techniques and the pumps used in each. It covers high performance liquid chromatography (HPLC), ion-exchange chromatography, and size-exclusion chromatography. For HPLC, it describes reciprocating piston pumps that are able to deliver precise, pulse-free flow at high pressures up to 10,000 psi. For ion-exchange chromatography, it mentions pumps must provide pulse-free flow for sensitive detectors and single piston pumps are commonly used. Size-exclusion chromatography utilizes small volume reciprocating pumps for accurately controlled flow rates at pressures up to 7,250 psi.
In this slide contains principle of IR spectroscopy and sampling techniques.
Presented by: R.Banuteja (Department of pharmaceutical analysis).
RIPER, anantpur.
Calibration of infrared (IR) spectroscopy ensures the instrument provides accurate measurements. The calibration process involves using a polystyrene film standard to produce an IR spectrum. The spectrum is compared to a reference standard to check if the strongest peak is within 95% of the maximum. If not, adjustments are made to correct the signal. Periodic calibration is needed to account for instrument drift over time and ensure precise results.
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Thermal detectors contain a small active element that absorbs radiation and experiences a temperature change. The temperature change is inversely proportional to the exposed surface area of the element. There are several types of thermal detectors including thermocouples, thermistors, and pneumatic devices like the Golay cell. Thermocouples use two dissimilar metals where radiation heats the junction and creates a potential difference. Thermistors are made of materials with resistance highly dependent on temperature. Pyroelectric detectors contain non-centrosymmetric crystals that generate an electric field in response to temperature change rate. The Golay cell consists of a gas-filled cylinder with a flexible diaphragm that deforms in response to pressure changes
This document discusses instrumentation methods of fluorimetry. It describes the key components of a fluorimeter including light sources like mercury vapor lamps and xenon arc lamps, filters and monochromators to select wavelengths of light, sample cells to hold liquid samples, and detectors like photomultiplier tubes and photovoltaic cells. Common types of fluorimeters are single beam, double beam, and spectrofluorimeters. Applications include determination of inorganic substances, proteins, and drugs.
This document provides an overview of different ionization techniques used in mass spectrometry. It discusses gas phase ionization methods like electron impact and chemical impact ionization. It also covers desorptive ionization techniques such as field desorption, fast atom bombardment, and matrix-assisted laser desorption ionization. Finally, it summarizes evaporative ionization methods like atmospheric pressure chemical ionization and atmospheric pressure photoionization. The document aims to explain the basic principles, applications, advantages, and limitations of various ionization methods for mass spectrometry analysis.
Multi component analysis (uv visible spectroscopy) by mr. pradeep swarnkar)Pradeep Swarnkar
This document discusses multi-component analysis using UV-Visible spectroscopy. It describes using the absorbance values of multiple components at different wavelengths to determine concentration ratios between the components known as Q values. The Q values can then be used to determine the individual concentrations of each component in a mixture.
Quantum numbers describe the quantized states of subatomic particles and electrons. There are four main quantum numbers: principal (n), angular momentum (l), magnetic (ml), and spin (ms). The principal quantum number represents the main energy level, angular momentum describes the orbital shape, magnetic represents orbital orientation, and spin describes intrinsic angular momentum. NMR spectroscopy utilizes the quantum spin states of nuclei to measure absorption of radio frequencies that match transitions between spin energy levels in an applied magnetic field.
Principle and application of ptgc and isothermal programmingAthira39
Gas chromatography is the separation of gaseous and volatile substances which is achieved by employing gas as a mobile phase and moving it through a column containing stationary phase which could be a liquid or solid.
Two methods of temperature control are used during gas chromatography:
Isothermal operation and;
Temperature programming
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
The document describes the development and validation of UV spectrophotometric methods for analyzing risperidone and lacosamide. It discusses selecting analytical wavelengths, developing standard curves, and validating the methods by determining accuracy, precision, specificity, linearity, range and other parameters as required by ICH guidelines. Validation results for the risperidone and lacosamide methods such as recovery percentages between 98.4-99.8%, precision of 0.67-0.50%, linear ranges of 2-6 μg/ml and 12-40 μg/ml respectively are also presented. The developed and validated methods provide accurate and precise quantification of active pharmaceutical ingredients and finished dosage forms using UV spectrophotometry.
Analytical methods validation as per ich & uspGANESH NIGADE
This document discusses analytical method validation as per ICH and USP guidelines. It defines validation as establishing documentary evidence that a procedure maintains compliance. Method validation involves demonstrating that an analytical procedure is suitable for its intended purpose by testing parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, ruggedness and robustness. It also discusses the different types of analytical procedures that require validation including identification tests, quantitative impurity tests, limit tests and assays.
Calibration and validation of HPLC methods involves establishing that the instrument produces accurate and reproducible results. Key aspects include:
1. Calibration involves checking parameters like flow rate accuracy, wavelength accuracy, and detector linearity using reference standards.
2. Validation establishes method performance meets requirements. It involves determining accuracy over 3 concentration levels, precision through repeatability studies, and linearity through correlation coefficients.
3. Qualification includes design, installation, operational, and performance qualification to prove equipment works correctly and leads to expected results.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
This document discusses validation parameters for analytical methods according to FDA, USP, and ICH guidelines. It outlines key parameters such as specificity, linearity, accuracy, precision, detection and quantitation limits, ruggedness, and robustness. Precision is discussed as having three levels - repeatability, intermediate precision, and reproducibility. The document also provides details on validation parameters like range, system suitability testing, and acceptance criteria for assays.
This document discusses various topics related to UV-visible spectroscopy including:
1. Choice of solvents and their effects on UV-visible spectra. Polar solvents can cause red or blue shifts in absorption maxima depending on the solute.
2. Applications of UV-visible spectroscopy like quantitative analysis of single and multiple component samples and qualitative analysis through structural elucidation, detection of functional groups, and identification of compounds.
3. Difference spectroscopy, where the difference in absorbance between two samples is measured to improve selectivity in the presence of interfering absorbers.
This document discusses the calibration of various analytical instruments used in pharmaceutical analysis. It begins with an introduction to calibration and the need for calibrating instruments. It then provides details on calibrating UV-Vis spectrophotometers, IR spectrophotometers, spectrofluorimeters, HPTLC, and gas chromatography. For each instrument, it describes the parameters checked during calibration such as wavelength accuracy, resolution, photometric accuracy, linearity, and acceptance criteria. The document aims to explain the calibration process for key analytical tools to ensure accurate measurements.
UV/visible spectroscopy involves measuring the absorption of ultraviolet or visible light by molecules. It utilizes light in the wavelength range of 200-800 nm.
The key components of a UV-visible spectrophotometer are a light source, wavelength selector such as a monochromator, sample holder, detector, and associated electronics. Common light sources include deuterium lamps, tungsten lamps, and mercury lamps. Samples are typically held in quartz or glass cuvettes. Detectors include phototubes and photodiodes.
UV-visible spectroscopy can be used to analyze samples containing multiple components. Methods for multicomponent analysis include simultaneous equations using absorption data at two wavelengths, absorbance ratio methods
This document discusses different types of chromatography techniques and the pumps used in each. It covers high performance liquid chromatography (HPLC), ion-exchange chromatography, and size-exclusion chromatography. For HPLC, it describes reciprocating piston pumps that are able to deliver precise, pulse-free flow at high pressures up to 10,000 psi. For ion-exchange chromatography, it mentions pumps must provide pulse-free flow for sensitive detectors and single piston pumps are commonly used. Size-exclusion chromatography utilizes small volume reciprocating pumps for accurately controlled flow rates at pressures up to 7,250 psi.
In this slide contains principle of IR spectroscopy and sampling techniques.
Presented by: R.Banuteja (Department of pharmaceutical analysis).
RIPER, anantpur.
Calibration of infrared (IR) spectroscopy ensures the instrument provides accurate measurements. The calibration process involves using a polystyrene film standard to produce an IR spectrum. The spectrum is compared to a reference standard to check if the strongest peak is within 95% of the maximum. If not, adjustments are made to correct the signal. Periodic calibration is needed to account for instrument drift over time and ensure precise results.
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Thermal detectors contain a small active element that absorbs radiation and experiences a temperature change. The temperature change is inversely proportional to the exposed surface area of the element. There are several types of thermal detectors including thermocouples, thermistors, and pneumatic devices like the Golay cell. Thermocouples use two dissimilar metals where radiation heats the junction and creates a potential difference. Thermistors are made of materials with resistance highly dependent on temperature. Pyroelectric detectors contain non-centrosymmetric crystals that generate an electric field in response to temperature change rate. The Golay cell consists of a gas-filled cylinder with a flexible diaphragm that deforms in response to pressure changes
This document discusses instrumentation methods of fluorimetry. It describes the key components of a fluorimeter including light sources like mercury vapor lamps and xenon arc lamps, filters and monochromators to select wavelengths of light, sample cells to hold liquid samples, and detectors like photomultiplier tubes and photovoltaic cells. Common types of fluorimeters are single beam, double beam, and spectrofluorimeters. Applications include determination of inorganic substances, proteins, and drugs.
This document provides an overview of different ionization techniques used in mass spectrometry. It discusses gas phase ionization methods like electron impact and chemical impact ionization. It also covers desorptive ionization techniques such as field desorption, fast atom bombardment, and matrix-assisted laser desorption ionization. Finally, it summarizes evaporative ionization methods like atmospheric pressure chemical ionization and atmospheric pressure photoionization. The document aims to explain the basic principles, applications, advantages, and limitations of various ionization methods for mass spectrometry analysis.
Multi component analysis (uv visible spectroscopy) by mr. pradeep swarnkar)Pradeep Swarnkar
This document discusses multi-component analysis using UV-Visible spectroscopy. It describes using the absorbance values of multiple components at different wavelengths to determine concentration ratios between the components known as Q values. The Q values can then be used to determine the individual concentrations of each component in a mixture.
Quantum numbers describe the quantized states of subatomic particles and electrons. There are four main quantum numbers: principal (n), angular momentum (l), magnetic (ml), and spin (ms). The principal quantum number represents the main energy level, angular momentum describes the orbital shape, magnetic represents orbital orientation, and spin describes intrinsic angular momentum. NMR spectroscopy utilizes the quantum spin states of nuclei to measure absorption of radio frequencies that match transitions between spin energy levels in an applied magnetic field.
Principle and application of ptgc and isothermal programmingAthira39
Gas chromatography is the separation of gaseous and volatile substances which is achieved by employing gas as a mobile phase and moving it through a column containing stationary phase which could be a liquid or solid.
Two methods of temperature control are used during gas chromatography:
Isothermal operation and;
Temperature programming
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
The document describes the development and validation of UV spectrophotometric methods for analyzing risperidone and lacosamide. It discusses selecting analytical wavelengths, developing standard curves, and validating the methods by determining accuracy, precision, specificity, linearity, range and other parameters as required by ICH guidelines. Validation results for the risperidone and lacosamide methods such as recovery percentages between 98.4-99.8%, precision of 0.67-0.50%, linear ranges of 2-6 μg/ml and 12-40 μg/ml respectively are also presented. The developed and validated methods provide accurate and precise quantification of active pharmaceutical ingredients and finished dosage forms using UV spectrophotometry.
Analytical methods validation as per ich & uspGANESH NIGADE
This document discusses analytical method validation as per ICH and USP guidelines. It defines validation as establishing documentary evidence that a procedure maintains compliance. Method validation involves demonstrating that an analytical procedure is suitable for its intended purpose by testing parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, ruggedness and robustness. It also discusses the different types of analytical procedures that require validation including identification tests, quantitative impurity tests, limit tests and assays.
Calibration and validation of HPLC methods involves establishing that the instrument produces accurate and reproducible results. Key aspects include:
1. Calibration involves checking parameters like flow rate accuracy, wavelength accuracy, and detector linearity using reference standards.
2. Validation establishes method performance meets requirements. It involves determining accuracy over 3 concentration levels, precision through repeatability studies, and linearity through correlation coefficients.
3. Qualification includes design, installation, operational, and performance qualification to prove equipment works correctly and leads to expected results.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
M.pharm (Pharmaceutics) Modern Pharmaceutics unit- Validation Part-1 introduction, scope and merits of validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipment.
The document discusses good practices in the Blood and Marrow Transplant (BMT) Clinical and Marrow Collection Program's annual training. It defines various types of good practices (GxP), including Good Manufacturing Practice (GMP), Good Tissue Practice (GTP), Good Documentation Practice (GDP), and Good Clinical Practice (GCP). It explains that GxP standards guide work to ensure safety. BMT establishments must follow quality standards comparable to pharmaceutical manufacturers. The training covers GxP requirements like personnel qualifications, facilities and equipment, process validation, quality assurance, and auditing.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
The document discusses different types of validation processes that are important for pharmaceutical manufacturing. It describes process validation, cleaning validation, equipment validation, and validation of analytical methods. Process validation ensures a process is capable of consistently producing quality products and includes prospective, concurrent, retrospective, and revalidation. Cleaning validation aims to minimize cross-contamination. Equipment validation proves equipment works correctly. Validation of analytical methods establishes that test method performance meets requirements for intended use. Government regulations require validation to ensure drug quality and safety.
Point of-care, biosensors & mobile diagnostics europe 2019Erik Vollebregt
The document discusses the legal and regulatory changes brought about by the new In Vitro Diagnostic Medical Devices Regulation (IVDR) and General Data Protection Regulation (GDPR) in Europe. Key points include:
- The IVDR significantly increases regulatory requirements for diagnostic devices and shifts many devices that previously did not require notified body review to now requiring it.
- Compliance with both the IVDR and GDPR is required as the IVDR demands more performance and clinical data that involves personal health information protected by the GDPR.
- Manufacturers must complete extensive remediation work to conform to the new regulations by the 2022 deadline or risk removing non-compliant devices from the market. The bottleneck of notified body capacity
This document discusses guidelines for equipment selection, purchase, specification, and maintenance in the pharmaceutical industry. It begins by defining equipment and its importance in pharmaceutical manufacturing. It then outlines the various stages of an equipment's lifecycle from the decision to purchase through maintenance and disposal. The document reviews guidelines from organizations like WHO, USFDA, MHRA, and others regarding factors to consider in equipment design, cleaning, identification, calibration, and record keeping. It emphasizes that equipment must be suitable for its intended use and not negatively impact product quality.
Basic Instruments-Equipment; Application and Management.pptxRajendra Dev Bhatt
Equipment management (Buying to Disposing) is one of the essential elements out of 12 quality management system.
Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable, and timely testing.
This document discusses current good manufacturing practices (cGMP) and industrial management. It begins with an introduction to cGMP and its regulation by the FDA. It then discusses various aspects of cGMP including plant layout, facilities, equipment, production organization, materials management, inventory control, and quality management. The objectives of cGMP are to ensure product quality and consistency in manufacturing. Total quality management aims to meet customer needs and expectations at every stage of production.
1. The document discusses pharmaceutical validation including calibration and validation master plans. It defines validation and calibration, outlines their objectives and importance.
2. It describes the scope and methods of validation including process, analytical, equipment and cleaning validation. It also discusses the merits of validation in ensuring consistency and reducing risks.
3. The document provides details on validation master plans including contents such as introduction, methodology, personnel, schedules, documentation etc. It also discusses calibration master plans, the need for periodic calibration of instruments and maintaining calibration records.
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.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
How to get your COVID-19 Related Medical Device to Market Under FDA Emergency...Greenlight Guru
What quality and regulatory steps are needed to get your COVID-19 related device on the market under FDA Emergency Use Authorization. The FDA has been very active in publishing new guidances and updates for COVID-19 related devices that are in high demand. RookQS has worked with many manufacturers and distributors around the world to address the COVID-19 related shortages on devices, diagnostics, and PPE.
• Overview of the requirements for the COVID related devices and supplies under high demand during the current COVID pandemic
• Overview on diagnostic and at home testing kits
• Overview on hand sanitizer registration and testing for manufacturers and distributors
• Overview on respirator regulations and testing for manufacturers and distributors
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
A Calibration Master Plan (CMP) defines the process for calibrating equipment used in pharmaceutical manufacturing. It establishes equipment criticality, calibration intervals, responsibilities, and procedures to ensure equipment performance and compliance with regulations. The CMP process involves classifying equipment, scheduling and performing calibrations, issuing certificates, and using calibration management software to improve efficiency and monitoring. The goal is to maintain measurement accuracy and reliability through regular calibration.
The document summarizes current good manufacturing practices (cGMPs) for pharmaceutical manufacturing as regulated by the FDA. It discusses that cGMPs provide quality standards to ensure identity, strength, quality and purity of drugs. Key aspects of cGMPs covered include facilities and equipment design, production process controls, packaging and labeling, quality testing, and record keeping. Adherence to cGMPs helps assure proper design and monitoring of manufacturing to maintain compliance.
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Acute respiratory infection (ARI) is an infection that interferes with normal breathing by affecting the upper or lower respiratory tract. Common causative organisms include rhinoviruses, respiratory syncytial virus, influenza virus, and parainfluenza virus. Symptoms include congestion, runny nose, cough, sore throat, body aches, and fatigue. ARIs are transmitted through airborne droplets from coughing or sneezing. Prevention methods include breastfeeding, avoiding indoor air pollution, and immunizing against measles, HIB, pneumococcal disease, and other pathogens. WHO is working to improve diagnosis and management of ARIs.
Acute respiratory infections (ARIs) are classified as upper respiratory tract infections (URIs) or lower respiratory tract infections (LRIs). The upper respiratory tract consists of the airways from the nostrils to the vocal cords in the larynx, including the paranasal sinuses and the middle ear.
ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.
Nucleophilic substitution reactions are a class of reactions in which an electron rich nucleophile attacks a positively charged electrophile to replace a leaving group. For alginate reactions, the most reactive nucleophile is the C6 carboxylate group
The classical approach for prodrug design uses the non-specific strategy of covalently modifying the drug of interest by attaching hydrophilic functionalities
The document discusses protecting groups for amino groups and amino acids. It first introduces the concept of protecting groups by explaining that they make it possible to selectively react a less reactive functional group in the presence of a more reactive group. It notes that protecting groups block reactivity by converting the functional group to an inert form. The document then lists desirable qualities for choosing a suitable protecting group, including being cheap, stable to reaction conditions, and easy to remove. It proceeds to discuss carbamate and amide protecting groups specifically for amino groups.
NMR Spectroscopy is abbreviated as Nuclear Magnetic Resonance spectroscopy. Nuclear magnetic resonance (NMR) spectroscopy is the study of molecules by recording the interaction of radiofrequency (Rf) electromagnetic radiations with the nuclei of molecules placed in a strong magnetic field.
Infrared (IR) spectroscopy is an absorption method widely used in both qualitative and quantitative analyses. The infrared region of the spectrum includes electromagnetic radiation that can alter the vibrational and rotational states of covalent bonds in organic molecules.The IR spectrum of an organic compound is a unique physical property and can be used to identify unknowns by interpretation of characteristic absorbances and comparison with spectral libraries. IR spectroscopy is also used in quantitative techniques because of its sensitivity and selectivity. It can be used to quantitate analytes in complex mixtures and is used extensively in detection of industrial pollutants in the environment.
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The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
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it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
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2. CALIBRATION
• It is a comparison between the known measurement (standard) and the
measurement using the instrument.
REASON FOR CALIBRATION
• A new instrument
• After an instrument has been repaired or modified
• When a specified time period has elapsed
• When a specified usage (operating hours) has elapsed
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3. INTRODUCTION
• Calibration of a device is carried out to minimize the uncertainty in
measurements.
• It helps in reducing the errors and brings the measurement to an
acceptable level.
• With repeated use and over a period of time, all equipment tends to
degrade and that affects its accuracy and precision.
• In the medical device industry, a drift in the measurement is
unacceptable.
• Regular maintenance and service are needed for an instrument to work
accurately and at its optimum.
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4. • For medical device manufacturers, the health and safety of patients
remain their top priority.
• Therefore, the precision and accuracy of a device is of utmost
importance.
• To safeguard the interest of the users and to ensure that public health
and safety isn't compromised, the medical device industry is regulated
by strict standards, including FDA's 21 CFR Parts 11 and 820, Quality
System Regulation (QSR) and ISO 13485.
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5. USFDA GUIDELINES
• Title 21 of the FDA's Code of Federal Regulations defines the
calibration requirements for equipment.
• According to section 820.72, manufacturers have to inspect, measure,
and test equipment to ensure that it is suitable for its intended use and
that it is capable of providing valid results.
• It also states that manufacturers must have provisions to handle,
preserve, or store the equipment.
• These activities have to be recorded and documented.
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6. ANALYTICAL PROTOCOL
• Calibration must be performed on a regular basis to check its accuracy
and precision and, if any errors are found, corrective measures have to
be taken if any, must be evaluated and documented.
• The procedures for how to calibrate an instrument must be easily
accessible to the designated staff of the company.
• Procedures should include how to calibrate the instrument and should
include the acceptable range for accuracy and precision.
• The procedure that is used to inspect, measure, and test equipment
should be traceable to national or international standards.
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7. FDA guidelines for calibration of a medical device
require the following
• Equipment calibration must be carried out routinely, as per the
company's written directions.
• Calibration of every device that needs to be calibrated must be
documented.
• Acceptable limits for accuracy and precision must be specified.
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8. • Calibration personnel must be trained.
• Calibration standards must be traceable to the national standards, in-
house standards (if necessary), or other acceptable standards have to
be used.
• Provisions have to be made for evaluating adverse effects caused by
the defective equipment, and corrective measures must be taken.
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10. CALIBRATION:
• As per FDA's medical device calibration requirements, all medical
device companies need to have procedures in place that include
instructions and acceptable limits for accuracy and precision.
• If a medical device fails to meet these standards for precision and
accuracy, then the manufacturer must calibrate the medical device to
improve its quality until the standards are met and must document all
procedures involved.
• Calibration shall be completed within +/- 7 days from the due date for
critical equipment & non critical equipment shall be completed within
+/- 15 days.
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11. STANDARDS
• If the standards for calibrating a medical device are absent, FDA
states that relevant national, international, state, or local standards
need to be applied.
• If no standard exist, the manufacturer must form its own set of
requirements, and the medical device must be calibrated to meet those
requirements.
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12. DOCUMENTATION
• Part 21 CFR 820.72 states that manufacturers must document all the
points of calibration, including the following:
• The date the device was picked up for calibration.
• The name of the staff who performed the calibration.
• When the next calibration is due.
• All of these records need to be made accessible to the designated
personnel of the company.
• For an instrument calibration program to remain in compliance with
FDA, it is important to maintain a calibration schedule. Missed
calibration cycles can compromise the quality of the product, resulting
in non-compliance.
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