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Analytical method validation as per ICH and USP guidelines
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When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
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Prepared By : Sanjay Sharma (Sr. Analyst) For 4 important concepts related to method validation- instrument detection limit, method detection limit, below detection limit and recovery. When signals from absolute analytes are considerably greater than signals produced by analytical instruments, it is referred to as the instrument detection limit. Method detection limit is the least amount of a substance in a sample which can be measured and if substance is even below that level, it is referred as below detection limit.
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When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
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Prepared By : Sanjay Sharma (Sr. Analyst) For 4 important concepts related to method validation- instrument detection limit, method detection limit, below detection limit and recovery. When signals from absolute analytes are considerably greater than signals produced by analytical instruments, it is referred to as the instrument detection limit. Method detection limit is the least amount of a substance in a sample which can be measured and if substance is even below that level, it is referred as below detection limit.
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Prepared by : Santram Rajput (Technical Manager) Validation of analytical procedures reinforce the reliability and suitability of a methodology for providing accurate and precise results. This slide show elaborates in detail about the need for method validation with examples, along with that it also covers the factors to be evaluated prior to validation. This slide show further touches upon the characteristics which are of significance in context of the validation procedure.
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Prepared By : Subrata SInha (Senior Analyst) Analytical method validation’s superlative characteristic, linearity is comprehensively explained in this slide show. Linearity commonly understood as proportional relationship between two units, in context of method validation, it refers toproportional relationship between test results and concentrations.
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What is Validation? Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry Validation is a process-risk will determine the effort High Risk:Total validation Moderate Risk:Testing,Documentation Low Risk:Testing the change Validation of Analytical Methods-Key Steps Preparation Experimentation Transfering Method Documentation Step 1- Preparation Develop validation project plan Define purpose/scope of method (performance criteria) Define and verify performance of equipment Qualify/validate materials Qualify/train operator Step 2- Experimentation Perform validation experiments- may have to change either equipment or limits Develop SOPs for executing the method in routine Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks Define change control procedure Document validation experiments and results Step 3- Transferring Methods to RoutineLaboratories Designate project owner Develop procedure on how to use method Develop system suitability tests (test procedure, frequency, acceptance criteria) Define transfer tests and acceptance criteria in the routine Train routine lab analyst in development lab Repeat 2 critical method validation tests in routine lab Analyze at least three samples in development and routine lab Analyst in routine lab should give frequent feedback Step 4- Documentation for the FDA Validation report and supporting documentation: Objective, scope Methodology Materials Equipment Validation data Supporting documentation (chromatograms, spectra) Transfer to routine protocol Reference to SOP Want to learn more about analytical method validation, FDA and ICH requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: ICH, FDA and USP Requirements for Method Validation How to Validate Analytical Methods and Procedures Validation of Analytical Methods and Procedures Eliminate the Confusion - Analytical Method Qualification and Validation Lifecycle Approach to Analytical Methods with QbD Elements Analytical Instrument Qualification and System Validation Lifecycle Approach to Analytical Methods for Drug Products For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=valppt
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What is Validation? Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry Validation is a process-risk will determine the effort High Risk:Total validation Moderate Risk:Testing,Documentation Low Risk:Testing the change Accuracy ICH defines accuracy of an analytical procedure as the closeness of agreement between the conventional true value or an accepted reference value and the value found. % Accuracy = Experimental- True Value * 100 True Value Precision Precision of analytical procedure is defined as closeness of agreement in values between a series of measurements. As per ICH, precision is considered at three different levels: Repeatability or intra—assay precision: precision data are obtained by repeatedly analyzing, in one lab on one day, aliquots of a homogeneous sample. Intermediate precision: precision obtained when the assay is performed by multiple analysts, multiple instruments, and multiple days in one lab. Reproducibility: precision between laboratories. Specificity Specificity is the ability of the method to accurately measure the analyte response in the presence of all potential sample components. It is very important in the analysis of complex mixtures by GC, HPLC, AA, ICP, etc. Limit of Detection (LOD) Limit of Detection (LOD) is the lowest amount of analyte in a sample which can be reliably detected but not necessarily accurately or precisely measured. Signal/Noise = 2 to 3 Limit of Quantitation (LOQ) Limit of Quantitation (LOQ) is the lowest amount of an analyte that can be quantitatively determined with suitable precision and accuracy. Signal/Noise = 10 to 20 Linearity and Range Linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. Range: Interval from the upper to the lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity Must cover 80-120% of product claims Usually evaluated from the same data set as linearity, precision, accuracy Want to learn more about analytical method validation, FDA requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: ICH, FDA and USP Requirements for Method Validation How to Validate Analytical Methods and Procedures Validation of Analytical Methods and Procedures Eliminate the Confusion - Analytical Method Qualification and Validation Lifecycle Approach to Analytical Methods with QbD Elements Analytical Instrument Qualification and System Validation Lifecycle Approach to Analytical Methods for Drug Products For details vis
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Method validation is the process of proving that an analytical method is acceptable for its intended purposes. METHOD VALIDATION = ERROR ASSESSMENT Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug products Validation: Prior ConsiderationsSuitability of Instrument Status of Qualification and Calibration Suitability of Materials Status of Reference Standards, Reagents, Placebo Lots Suitability of Analyst Status of Training and Qualification Records Suitability of Documentation Written and approved standard test procedure and proper approved protocol with pre-established acceptance criteria Compendial vs. Non-compendial Methods Compendial methods-Verification Regulatory analytical procedure in USP/NF Non- compendial methods-Validation Alternative analytical procedure proposed by the applicant for use instead of the regulatory analytical procedure Chromatographic Methods Demonstrate Resolution Impurities/Degradants Available Spike with impurities/degradants Show resolution and a lack of interference Impurities/Degradants Not Available Stress SamplesFor assay, Stressed and Unstressed Samples should be compared. Ability of an analytical method to measure the analyte free from interference due to other components. Selectivity describes the ability of an analytical method to differentiate various substances in a sample Original term used in USP Also Preferred by IUPAC and AOAC Also used to characterize chromatographic columns Degree of Bias (Used in USP) The difference in assay results between the two groups the sample containing added impurities, degradation products, related chemical compounds, placebo ingredients Selectivity: For impurity test, impurity profiles should be compared. Temperature (50-60℃) Humidity (70-80%) Acid Hydrolysis (0.1 N HCl) Base Hydrolysis (0.1 N NaOH) Oxidation (3-30%) Light (UV/Vis/Fl) Intent is to create 10 to 30 % Degradation Change in the analytical procedure, drug substance, drug product, the changes, may necessitate revalidation of the analytical procedures. “The degree of revalidation depends on the nature of the change.” “FDA intends to provide guidance in the future on post-approval changes in analytical procedures.” By Visual Inspection of plot of signals vs. analyte concentration By Appropriate statistical methods Linear Regression (y = mx + b) Correlation Coefficient, y-intercept (b), slope (m) Acceptance criteria: Linear regression r2 > 0.999 Requires a minimum of 6 concentration levels Normally derived from Linearity studies. Established by confirming that the method provides acceptable degree of linearity, accuracy, and precision. Specific range dependent upon intended application of the procedure.
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What is Validation? Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry Validation is a process-risk will determine the effort High Risk:Total validation Moderate Risk:Testing,Documentation Low Risk:Testing the change Validation of Analytical Methods-Key Steps Preparation Experimentation Transfering Method Documentation Step 1- Preparation Develop validation project plan Define purpose/scope of method (performance criteria) Define and verify performance of equipment Qualify/validate materials Qualify/train operator Step 2- Experimentation Perform validation experiments- may have to change either equipment or limits Develop SOPs for executing the method in routine Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks Define change control procedure Document validation experiments and results Step 3- Transferring Methods to RoutineLaboratories Designate project owner Develop procedure on how to use method Develop system suitability tests (test procedure, frequency, acceptance criteria) Define transfer tests and acceptance criteria in the routine Train routine lab analyst in development lab Repeat 2 critical method validation tests in routine lab Analyze at least three samples in development and routine lab Analyst in routine lab should give frequent feedback Step 4- Documentation for the FDA Validation report and supporting documentation: Objective, scope Methodology Materials Equipment Validation data Supporting documentation (chromatograms, spectra) Transfer to routine protocol Reference to SOP Want to learn more about analytical method validation, FDA and ICH requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: ICH, FDA and USP Requirements for Method Validation How to Validate Analytical Methods and Procedures Validation of Analytical Methods and Procedures Eliminate the Confusion - Analytical Method Qualification and Validation Lifecycle Approach to Analytical Methods with QbD Elements Analytical Instrument Qualification and System Validation Lifecycle Approach to Analytical Methods for Drug Products For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=valppt
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What is Validation? Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry Validation is a process-risk will determine the effort High Risk:Total validation Moderate Risk:Testing,Documentation Low Risk:Testing the change Accuracy ICH defines accuracy of an analytical procedure as the closeness of agreement between the conventional true value or an accepted reference value and the value found. % Accuracy = Experimental- True Value * 100 True Value Precision Precision of analytical procedure is defined as closeness of agreement in values between a series of measurements. As per ICH, precision is considered at three different levels: Repeatability or intra—assay precision: precision data are obtained by repeatedly analyzing, in one lab on one day, aliquots of a homogeneous sample. Intermediate precision: precision obtained when the assay is performed by multiple analysts, multiple instruments, and multiple days in one lab. Reproducibility: precision between laboratories. Specificity Specificity is the ability of the method to accurately measure the analyte response in the presence of all potential sample components. It is very important in the analysis of complex mixtures by GC, HPLC, AA, ICP, etc. Limit of Detection (LOD) Limit of Detection (LOD) is the lowest amount of analyte in a sample which can be reliably detected but not necessarily accurately or precisely measured. Signal/Noise = 2 to 3 Limit of Quantitation (LOQ) Limit of Quantitation (LOQ) is the lowest amount of an analyte that can be quantitatively determined with suitable precision and accuracy. Signal/Noise = 10 to 20 Linearity and Range Linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. Range: Interval from the upper to the lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity Must cover 80-120% of product claims Usually evaluated from the same data set as linearity, precision, accuracy Want to learn more about analytical method validation, FDA requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: ICH, FDA and USP Requirements for Method Validation How to Validate Analytical Methods and Procedures Validation of Analytical Methods and Procedures Eliminate the Confusion - Analytical Method Qualification and Validation Lifecycle Approach to Analytical Methods with QbD Elements Analytical Instrument Qualification and System Validation Lifecycle Approach to Analytical Methods for Drug Products For details vis
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Method validation is the process of proving that an analytical method is acceptable for its intended purposes. METHOD VALIDATION = ERROR ASSESSMENT Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug products Validation: Prior ConsiderationsSuitability of Instrument Status of Qualification and Calibration Suitability of Materials Status of Reference Standards, Reagents, Placebo Lots Suitability of Analyst Status of Training and Qualification Records Suitability of Documentation Written and approved standard test procedure and proper approved protocol with pre-established acceptance criteria Compendial vs. Non-compendial Methods Compendial methods-Verification Regulatory analytical procedure in USP/NF Non- compendial methods-Validation Alternative analytical procedure proposed by the applicant for use instead of the regulatory analytical procedure Chromatographic Methods Demonstrate Resolution Impurities/Degradants Available Spike with impurities/degradants Show resolution and a lack of interference Impurities/Degradants Not Available Stress SamplesFor assay, Stressed and Unstressed Samples should be compared. Ability of an analytical method to measure the analyte free from interference due to other components. Selectivity describes the ability of an analytical method to differentiate various substances in a sample Original term used in USP Also Preferred by IUPAC and AOAC Also used to characterize chromatographic columns Degree of Bias (Used in USP) The difference in assay results between the two groups the sample containing added impurities, degradation products, related chemical compounds, placebo ingredients Selectivity: For impurity test, impurity profiles should be compared. Temperature (50-60℃) Humidity (70-80%) Acid Hydrolysis (0.1 N HCl) Base Hydrolysis (0.1 N NaOH) Oxidation (3-30%) Light (UV/Vis/Fl) Intent is to create 10 to 30 % Degradation Change in the analytical procedure, drug substance, drug product, the changes, may necessitate revalidation of the analytical procedures. “The degree of revalidation depends on the nature of the change.” “FDA intends to provide guidance in the future on post-approval changes in analytical procedures.” By Visual Inspection of plot of signals vs. analyte concentration By Appropriate statistical methods Linear Regression (y = mx + b) Correlation Coefficient, y-intercept (b), slope (m) Acceptance criteria: Linear regression r2 > 0.999 Requires a minimum of 6 concentration levels Normally derived from Linearity studies. Established by confirming that the method provides acceptable degree of linearity, accuracy, and precision. Specific range dependent upon intended application of the procedure.
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