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Relevant bibliographies by topics / Validation as per ICH guidelines

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Academic literature on the topic 'Validation as per ICH guidelines'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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Journal articles on the topic "Validation as per ICH guidelines"

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Bhatia, Ritika, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol tablet as per ICH guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 11–23. http://dx.doi.org/10.32553/ijmbs.v7i6.2713.

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Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emp

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Tayyaba, Mahtab*and S. Ramya Sri. "RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALPRAZOLAM AND IMIPRAMINE AS PER ICH GUIDELINES." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2027–39. https://doi.org/10.5281/zenodo.1214513.

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Alprazolam and Imipramine, in its pure form as well as in tablet dosage form. Chromatography was carried out on an Inertsil column, C18(150x4.6 ID) 5µm column using a mixture of Phosphate buffer : ACN (30:70) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 238nm. The Retention Time of the 2.397min for Alprazolam and 3.493 min for Imipramine. The method produce linear responses in the concentration range of 0.5-1.5µg /ml for Alpra

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Shantappa Birajdar, Arunadevi. "New Method Development by HPLC and Validation as per ICH Guidelines." Acta Scientific Pharmaceutical Sciences 4, no. 4 (2020): 55–60. http://dx.doi.org/10.31080/asps.2020.04.0517.

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Shah, Devanshi, Vinit Movaliya, Shruti Kharidia, and Maitreyi Zaveri. "Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines." International Journal of Drug Regulatory Affairs 12, no. 2 (2024): 58–64. http://dx.doi.org/10.22270/ijdra.v12i2.675.

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Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory

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Vikas, Chougule, Rajmane Manjiri, Chougule Nilesh, Desai Abhishek, Rohile Vinayak, and Inamdar Nasruddin. "Development Of Reverse-Phase High-Performance Liquid Chromatographic and UV-Spectrophotometric Method with Validation For Octenidine Dihydrochloride." American Journal of PharmTech Research 12, no. 3 (2022): 179–88. https://doi.org/10.5281/zenodo.7106700.

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ABSTRACT The purpose of this research is to develop and validate a precise method for UV-Vis spectrophotometric and Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) for determination of Octenidine dihydrochloride in bulk and pharmaceutical preparation. According to the relevant experiment the maximum wavelength was found to be 285nm and it is used for further process of development of method and its validation. The developed methods used for quantitative estimation of Octenidine dihydrochloride in pharmaceutical preparation and bulk drug which shows the satisfactory results as pe

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Prajapati, Krunal J., and Charmy Kothari. "Development and Validation of a Stability Indicating LC-MS/MS Method for the Determination of Clenbuterol HCl." Drug Research 70, no. 12 (2020): 552–62. http://dx.doi.org/10.1055/a-1167-0529.

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AbstractClenbuterol hydrochloride (CLT), β2 adrenergic agonist is used as a bronchodilator in the therapeutic treatment of asthma. It is important to know the stability behaviour of the drug in different degradation conditions as per ICH Q1A (R2) guidelines for safety and efficacy purpose. The main objective of the study is to develop and validate stability indicating LC-MS/MS method for the determination of Clenbuterol HCl. The separation was achieved using Phenomenex Gemini NX C18 (250*4.6 mm, 5 μ) column and the mobile phase consisting of ammonium acetate buffer (5 mM), 0.15% triethylamine

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Prajapati, J. B., H. Rao, and H. Shah. "DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SELEGILINE HYDROCHLORIDE LOADED SOLID LIPID NANOPARTICLES." INDIAN DRUGS 56, no. 08 (2019): 57–60. http://dx.doi.org/10.53879/id.56.08.11297.

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The present paper discusses about a simple, precise and validated method for the determination of selegiline loaded solid lipid nanoparticles. The study was carried as per the parameters laid down in ICH guidelines. Maximum wavelength of selegiline in 8:2 methanol: chloroform mixture was selected at 258nm. The method was found to be linear in the range of 200μg/mL to 1000μg/mL with correlation coefficient R2 of 0.994. Method was successfully validating as per ICH guidelines. Moreover, this method was simple, sensitive and easy to apply and can be performed at laboratory scale. Hence, the propo

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Sahu, Sandeep, and Narendra Kumar Lariya. "Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 1236–39. http://dx.doi.org/10.22270/jddt.v9i4-s.3972.

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Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.28

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Dr., A. Madhukar *. Gariganti Swathi 1. Tanveer Fatima 2. Amina Fatima 2. Madhia Nikhat 2. Mohd Akram Mohsin 2. "A Simple Method Development and Validation for the Determination of Tolbutamide in Bulk and Marketed Dosage Form by UV - Spectrophotometric Technique." Journal of Pharma Research 9, no. 7 (2020): 6. https://doi.org/10.5281/zenodo.3931525.

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ABSTRACT The present work was to develop simple UV spectrophotometric methods for estimation of Tolbutamide (TOL) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Tolbutamide. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.49% and 100.78% respectively. The methods were validat

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Borkar, Dinesh P., Anup Barsagade, Nobel CP James, Suruchi Thakare, and Susmita Mandal. "Analytical Method Developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP-HPLC in Combination Dosage Form." Journal of Pharmaceutical Research International 36, no. 11 (2024): 163–73. http://dx.doi.org/10.9734/jpri/2024/v36i117609.

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A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of drugs in a combined pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in combination dosage form. The aim is "Analytical Method developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP- HPLC In C

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Book chapters on the topic "Validation as per ICH guidelines"

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Borman, Phillip, and David Elder. "Q2(R1) Validation of Analytical Procedures." In ICH Quality Guidelines. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781118971147.ch5.

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Ranjith, K., D. Rama Sekhara Reddy, and TEGK Murthy. "Development and Validation of Stability Indicating Related Substances Method for Montelukast Sodium and Levocetirizine Dihydrochloride Combined Tablets by RP-HPLC." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00304.

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In this paper authors presented the development and validation of RP-HPLC method for determination of related substances present in Montelukast sodium and Levocetirizine dihydrochloride combined tablets. Chromatographic separation was achieved on Hypersil ODS (150 x 4.6 mm),5 µ column with flow rate 1 mL/min, detection wavelength 238 nm, injection volume 10 µL, column temperature 40°C and run time 75 mins. Gradient programming was used with mobile phase-A (MP-A)-50mM acetate buffer pH 5.5 and mobile phase-B(MP-B)-methanol: MP-A (90:10 %v/v). Developed method was validated as per ICH Q2(R1) gui

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K, Shah Chandra, Dr Dedania Zarna, Dr Dedania Ronak, and Dr Jain Vineet C. "ANALYTICAL QBD APPROACH TO HPLC METHOD DEVELOPMENT AND VALIDATION FOR PREGABALIN." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 19. Iterative International Publisher, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bgpn19p1ch6.

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Analytical QbD helps to provideanalytical life cycle management by systemic method development and maintenance. An efficient CCD - Central Composite Design was developed at 23 factorial designs; mobile phase composition and pH kept as two different factors at law(-1), medium(0) and high(+1) at three levels for RP-HPLC method. The response to be evaluated being retention time, peak asymmetry and theoretical plates. The chromatographic separation conditions were optimized with the Design Expert Software version10.0.1.0, i.e. Inertsil ODS column C18 (250×4.6mm, 5.0µm), mobile phase used werephosp

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Chary, Vemuluri Padmabhushana, and D. Sireesha. "Calibration of Analytical Instruments as Per ICH and USFDA Guidelines." In Science and Technology: Recent Updates and Future Prospects Vol. 12. BP International, 2024. http://dx.doi.org/10.9734/bpi/strufp/v12/2062.

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"Method Validation and Documentation (Procedure 5)." In SIFT-MS. Royal Society of Chemistry, 2025. https://doi.org/10.1039/9781837677917-00281.

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As a chromatography-free analytical technique, selected ion flow tube mass spectrometry (SIFT-MS) speciates and quantifies volatile compounds in the gas phase using a very different approach to traditional laboratory techniques. Nevertheless, as described in this chapter, guidelines for analytical method validation, such as ICH Q2(R1), are readily adapted to both automated headspace-SIFT-MS analysis and less conventional SIFT-MS approaches. Additionally, recommendations are made for documentation of SIFT-MS methods for quality systems and routine use.

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Kasangaki, Wilberforce. "Method Validation and Verification." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/28x3yy16.

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Method validation establishes analytical procedure reliability through systematic performance evaluation. ICH Q2(R1) guidelines provide validation frameworks adaptable across development phases from early research through commercialization. Risk-based approaches align validation effort with method purpose and product criticality. Validation parameters include specificity testing against potential interferents, linearity across concentration ranges, accuracy through recovery studies, precision at repeatability and intermediate levels, detection and quantitation limit determination, and robustne

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Sruthy, Keerthy. "18 HERBS ORGANICS - STRESS RELIEF OIL – ASUVAGENTHI BALALAKSHATHI THAILAM." In Futuristic Trends in Medical Sciences Volume 3 Book 6. Iterative International Publisher, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bbms6p5ch3.

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We hereby attest to the authenticity of the study and guarantee that the data is accurate to the best of our knowledge. We also attest that the study was conducted in full compliance with BIS Specification, IS 4011:2018 Methods of test for safety evaluation of cosmetics, reaffirmed (2004), Edition 3.2 (2007-11), second revision (ICS 7 1.1 00.40), clause 4.3.1, 4.3.1.2 BIS 2008. Skin Irritation Test On human subjects, guidelines, and regulations of the Independent Scientific and Ethics Committee for the Purpose of control and supervision of experiments and on getting approval of the sponsor. Th

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Desai, Saloni S., Sejal M. Khuman, and Jeshika B. Patel. "HIGH PERFORMANCE LIQUID CHROMATOGRAPHY." In Emerging Pharmaceutical Sciences: Today and Tomorrow. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/nbennurch334.

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One type of column chromatography that is commonly used in biochemistry and analysis for the purpose of separating and quantify active compounds is called High Performance Liquid Chromatography (HPLC). HPLC is a frequently employed separation technique that is utilized to determine, separate, and measure the medication. In addition to a variety of various human and animal study, the development and validation of highperformance liquid chromatography techniques play critical roles in innovative drug identification, development, and production. The several steps needed in creating and verifying

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Mohammed, Jahasultana, and Buchi N. Nalluri. "Development and Validation of RP-HPLC-PDA Method for the Estimation of Fluoxetine Hydrochloride in Bulk, Mouth Dissolving Films and in Dissolution Samples." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00283.

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Selective serotonin reuptake inhibitor, fluoxetine hydrochloride (FLX) is a drug of choice for treating depression, obsessive-compulsive disorder (OCD), bulimia nervosa, etc. Even though FLX dosage forms such as tablets, capsules, oral solutions, and syrups are already available commercially, there is a considerable need for developing modified or immediate-release formulations with a quick onset of action and high bioavailability. The goal of this research is to provide a quick, practical, and cost-effective RP-HPLC-PDA approach for determining Fluoxetine hydrochloride (FLX) in bulk, mouth di

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Rajasekhar, K., Ch Gangu Naidu, Ch Naga Sesha Sai Pavan Kumar, K. Varaprasada Rao, and Y. Srinivasa Rao. "Development and Validation of A RP-HPLC Method for the Simultaneous Determination of Twenty Related Substances of Sulfamethoxazole and Trimethoprim in Injection Dosage Form." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00246.

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A simple, robust and for the quantification of experimentally 20 related impurities of sulfamethoxazole (SM) and trimethoprim (TM) in liquid pharmaceutical dosage form, a novel RP-HPLC method was developed. Utilizing gradient elution on a Kromasil 100-5-C18; 5.0 m, (4.0x250) mm, column, chromatographic separation was accomplished. Solvent A (solution of 0.08% orthophosphoric acid in water) and Solvent B (mixture of acetonitrile and methanol, 80:20 v/v), given at a flow rate of 0.8 ml/min, respectively, make up the mobile phase. Using a photodiode array (PDA) detector, the analytes were identif

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Conference papers on the topic "Validation as per ICH guidelines"

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Velјanova Martinoski, Elena. "QUALITY RISK MANAGEMENT - REGULATORY FRAMEWORK." In XX International Convention on Quality JUSK ICQ 2024. United Association of Serbia for Quality, 2024. http://dx.doi.org/10.46793/jusk-icqxx.058vm.

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t is known that at the time of drug safety approval, the amount of information is relatively limited. We are all witnessing a time when everything is very dynamic, a time of complete digitization and automation, where information’s are easily available. Additionally, the COVID-19 virus pandemic has forced rapid drug development and easy availability of drugs for patients. Dynamics carries many risks, so risk management techniques, although well known to the pharmaceutical industry, are becoming an increasingly popular and used tool. Risk management regulation is defined in EU and FDA quality g

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Tymofiienko, Mykhailo, and Liudmila Butsenko. "A development of a fast chromatographic method for indoleacetic acid determination in cell cultures." In VI International Conference on European Dimensions of Sustainablе Development. National University of Food Technologies, 2024. https://doi.org/10.24263/edsd-2024-6-34.

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This study presents the development and validation of a novel high-performance liquid chromatography method employing fluorescence detection for the rapid determination of indoleacetic acid (IAA) in bacterial cell cultures. IAA, a pivotal plant growth hormone, influences various physiological processes and is often employed as a marker to screen the growth-promoting properties of rhizosphere and endophytic bacteria. Current methods for IAA determination face challenges such as lengthy and costly sample preparations, complex matrix interferences, and the need for expensive equipment. This metho

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Mohammed, Rahima K., Ridvan A. Sahan, and Ying-Feng Pang. "System Level Thermal Design Challenges in Validation Platforms." In ASME 2009 InterPACK Conference collocated with the ASME 2009 Summer Heat Transfer Conference and the ASME 2009 3rd International Conference on Energy Sustainability. ASMEDC, 2009. http://dx.doi.org/10.1115/interpack2009-89412.

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Unprecedented growth in the semiconductor industry has been enabled by decreasing transistor feature size. As silicon technology continues to scale per Moore’s law, multi-core and many-core are the new trends of the semiconductor industry. While bus speeds, features and functionalities are increasing, shrinking system volume, compact component placements on the board and system noise reduction are the trends. These silicon and system trends make the thermal design challenging. Validation platforms are used to validate processors/chipsets to ensure world-class quality and reliable Intel product

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Espino, Danicsa, Carmen Arbulu, Madeleine Espino, et al. "Specialized nurse care for the patient with an internal tracheotomy cannula in the intensive care public hospital of Peru." In 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023). AHFE International, 2023. http://dx.doi.org/10.54941/ahfe1003482.

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In the intensive care unit (ICU), specialized critical care is provided to patients with multi- organ problems resulting from multiple diseases, requiring invasive and intensive care, therapy and monitoring with the support of high-tech equipment (Moreno et al., 2021). The general objective was to collect evidence to generate specialized nursing care guides for patients with internal tracheostomy cannula in intensive care units (ICU) in public hospitals of the Minsa of Peru. A type of secondary research was developed with an Evidence-Based Nursing methodology, formulating the PICOT clinical qu

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Ricco, Giovanni. "Mechanical Design of Electrical Isolation Joint." In ASME 2018 Pressure Vessels and Piping Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/pvp2018-84947.

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The Electrical Isolation Joint is considered a pressure vessel and is usually designed according to ASME VIII Div.1, but the code does not provide specific rules for the component. This paper provides the mechanical design of an Electrical Insulation Joint according to ASME VIII div.1, Appendix 2, “Rules for Bolted Flange.” The scope of this work is to suggest design guidelines to be included in the ASME VIII Div.1 code for Electrical Isolation Joints. The first part of the paper will introduce the geometry of typical electrical isolation joint and will show the distribution of stresses due to

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Lucio Neto, Mário, Bruno Santos Guimarães, Silmara Nunes Andrade, et al. "Educational booklet on oral health care for the elderly." In IV Seven International Congress of Health. Seven Congress, 2024. http://dx.doi.org/10.56238/homeivsevenhealth-014.

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Brazil will have an overpopulation of elderly people, with growth of around 3% per year, reaching 33% of the Brazilian population by 2050. The World Health Organization stresses that oral health is an important action to be taken to achieve healthy ageing. The aim of this study was to report on the experience of an educational initiative carried out in a family health unit. This is a descriptive experience report. An educational booklet was produced with guidelines and oral health care for the elderly based on the steps presented by Reberte et al. (2009), using the Canva application, in the LI

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Westwood, Stephen, Bala Ganapathy, Paul Spoering, Michael Zhou, and Taras Bolgachenko. "Verification of Internal Corrosion Through ILI and Non-Destructive Testing: Lessons Learned." In 2024 15th International Pipeline Conference. American Society of Mechanical Engineers, 2024. https://doi.org/10.1115/ipc2024-133557.

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Abstract Verification of In line Inspection results is often challenging for pipelines with internal corrosion, especially in areas of extensive corrosion and/or areas with challenging corrosion morphologies such as pinhole corrosion (as defined by the Pipeline Operators Forum [1]). The most reliable method which many operators choose is to rely on cut-outs for the purpose of both mitigation and ILI verification. However, depending on the diameter and the criticality of the pipeline, verification of internal corrosion features from in line inspection may be based exclusively on ultrasonic (UT)

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Gupta, A., S. Sarada, and A. Desai. "Parametric Study on the Structural Behavior and Failure Mechanism of the Grouted Connections." In Offshore Technology Conference. OTC, 2025. https://doi.org/10.4043/35959-ms.

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Abstract The structural integrity and safety of offshore substations heavily depend on the performance of grouted connections, which are subjected to various loading conditions and influenced by the nonlinear behavior of their constituent materials. This paper presents a comprehensive finite element modeling (FEM) approach, implemented in ABAQUS, to analyze the grouted connection between the leg and pile of an offshore substation. Nonlinear material models for steel (Ramberg-Osgood) and concrete (Drucker-Prager) were utilized, following DNV-RP-C208 guidelines and the ABAQUS damaged plasticity

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Antonakopoulou, Anna, Eva Grigoriadou, Pinelopi Alexiou, et al. "Approach to ensure inclusiveness for the identification of real mobility and public space re-design needs towards sustainability." In 15th International Conference on Applied Human Factors and Ergonomics (AHFE 2024). AHFE International, 2024. http://dx.doi.org/10.54941/ahfe1005335.

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The paper presents the methodology specified and followed in the context of the European funded project ELABORATOR, to provide a comprehensive framework that acts as a practical tool to advise all relevant parties of mobility innovation chain towards achieving a higher level of inclusivity in all phases of new mobility solutions and services’ design, implementation, deployment and evaluation. ELABORATOR aims to support cities in their transition towards climate neutrality by promoting zero-emission, active and human-centred mobility, with a special focus on inclusion. The methodology followed

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John, Shibu. "Asset Inspection Management System as a Reliable Inspection / Monitoring Tool to Optimize the Asset Utilization & Serviceability and to Enhance Overall Efficiency of Service Provision." In SPE Conference at Oman Petroleum & Energy Show. SPE, 2022. http://dx.doi.org/10.2118/200288-ms.

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Abstract Engineering Asset Management(EAM) is management of engineering assets and it provides guidelines on the effective usage of all the physical engineered assets within the organization. Similarly, Non-Destructive Testing [NDT] is used as a handy tool for integrity assessment of Assets in scheduled maintenance & inspection program. Though Asset Inspection in Oil & Gas Industry were using conventional NDT methods, now ASME, API and others came up with inspection procedures based on fracture mechanics, where each user to ascertain how their tool/regional operating condition deviate

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Reports on the topic "Validation as per ICH guidelines"

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Ramakrishnan, Aravind, Fangyu Liu, Angeli Jayme, and Imad Al-Qadi. Prediction of Pavement Damage under Truck Platoons Utilizing a Combined Finite Element and Artificial Intelligence Model. Illinois Center for Transportation, 2024. https://doi.org/10.36501/0197-9191/24-030.

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For robust pavement design, accurate damage computation is essential, especially for loading scenarios such as truck platoons. Studies have developed a framework to compute pavement distresses as function of lateral position, spacing, and market-penetration level of truck platoons. The established framework uses a robust 3D pavement model, along with the AASHTOWare Mechanistic–Empirical Pavement Design Guidelines (MEPDG) transfer functions to compute pavement distresses. However, transfer functions include high variability and lack physical significance. Therefore, as an improvement to effecti

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