This document discusses stability studies with reference to Unani medicine. It provides an overview of the importance and purpose of stability testing in ensuring the quality of medicines over time under various environmental factors. It discusses regulations around stability testing and expiry dates from ICH guidelines and India's Drugs and Cosmetics Act. The document also summarizes stability protocols, factors affecting drug stability, and types of stability studies including long term, intermediate, and accelerated studies. Unani literature from historical figures like Buqrat regarding the typical shelf life of different plant parts and formulations is also presented.
Data Analysis Of An Analytical Method Transfer ToDwayne Neal
To provide the basis for a PDA task force discussion to arrive at a consensus of best industry practices for data analysis of method transfers. The discussion is also relevant to method validation activities.
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
This document summarizes WHO guidelines for stability testing of liquid dosage forms. It outlines the key aspects that should be covered in stability protocols, including specifications tested, storage conditions and minimum time periods for long term, intermediate and accelerated studies. Specific recommendations are provided for drug substances, oral solutions, suspensions, small volume parenterals and other dosage forms. The purpose of stability testing is to provide evidence of a product's quality over time under various environmental factors and establish a re-test period or shelf life. Ongoing stability studies are also required to monitor products throughout their shelf life.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
Adverse Drug Reaction (ADR) Pharmacovigilance .
Here all about Adverse Drug Reaction and how to Report, Procedure and ADR Reporting form.
So You can all see in this slide share.
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
The European Medicines Agency and regulatory authorities in the EU prepare scientific guidelines to help applicants for herbal medicine marketing authorization. The guidelines provide a harmonized approach across EU states for demonstrating quality, safety, and efficacy of herbal medicines. They include guidelines on good practices for herb cultivation and collection, quality control of herbal substances and preparations, assessing genotoxicity and clinical safety/efficacy of herbal medicines, and public statements on allergic risks and contamination issues.
Data Analysis Of An Analytical Method Transfer ToDwayne Neal
To provide the basis for a PDA task force discussion to arrive at a consensus of best industry practices for data analysis of method transfers. The discussion is also relevant to method validation activities.
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
This document summarizes WHO guidelines for stability testing of liquid dosage forms. It outlines the key aspects that should be covered in stability protocols, including specifications tested, storage conditions and minimum time periods for long term, intermediate and accelerated studies. Specific recommendations are provided for drug substances, oral solutions, suspensions, small volume parenterals and other dosage forms. The purpose of stability testing is to provide evidence of a product's quality over time under various environmental factors and establish a re-test period or shelf life. Ongoing stability studies are also required to monitor products throughout their shelf life.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
Adverse Drug Reaction (ADR) Pharmacovigilance .
Here all about Adverse Drug Reaction and how to Report, Procedure and ADR Reporting form.
So You can all see in this slide share.
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
The European Medicines Agency and regulatory authorities in the EU prepare scientific guidelines to help applicants for herbal medicine marketing authorization. The guidelines provide a harmonized approach across EU states for demonstrating quality, safety, and efficacy of herbal medicines. They include guidelines on good practices for herb cultivation and collection, quality control of herbal substances and preparations, assessing genotoxicity and clinical safety/efficacy of herbal medicines, and public statements on allergic risks and contamination issues.
This document discusses bioequivalence standards for highly variable drug products. It begins by defining highly variable drug substances and products as those with intra-subject variabilities greater than 30%. It notes the sources of high variability can include administration conditions, physiological factors, and technical aspects. The usual standards for passing bioequivalence require average AUC and Cmax values to fall within 80-125% intervals. However, these criteria may be impossible to meet for highly variable drugs even with large sample sizes. The document therefore proposes alternative approaches for demonstrating bioequivalence of highly variable drugs, including replicate study designs and reference scaled average bioequivalence criteria. It provides examples and discusses some issues that can arise with these alternative approaches.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
The document presents an overview of ICH guidelines. It discusses that ICH was created in 1990 to harmonize pharmaceutical regulations between Europe, Japan, and the US. ICH has developed over 45 guidelines divided into quality, safety, efficacy, and multidisciplinary categories. The quality guidelines address chemical and pharmaceutical quality assurance. The safety guidelines cover preclinical safety testing. The efficacy guidelines relate to clinical trial design, conduct, and reporting. The multidisciplinary guidelines cover topics that do not fit uniquely into the other categories. In summary, the document provides a high-level introduction to the structure and guidelines of the International Council for Harmonisation.
This document summarizes guidelines for stability testing of biotechnological and biological products. It discusses factors that can affect stability, including temperature, humidity, light and container materials. The guidelines specify conducting real-time stability studies at the proposed storage temperature and testing potency, purity and degradation over time. Manufacturers must propose a stability-indicating profile and validate methods to detect any changes to the identity, purity or potency of the product.
The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
This document provides an overview of the ICH Q1A(R2) guideline for stability testing of new drug substances and products. The guideline defines the stability data package required for drug registration in major regions. It addresses testing timelines and conditions for long term, intermediate, and accelerated studies on at least three batches of drug substance and product. The goal is to establish a re-test period or shelf life and recommended storage conditions. Specifications must cover attributes susceptible to change that could impact quality, safety or efficacy. The guideline provides detailed recommendations for testing frequency, storage conditions, and evaluation of results.
Introduction to Research - Biostatistics and Research methodology 8th Sem Uni...Himanshu Sharma
This slide contains B.Pharm Biostatistics and Research methodology 8th Sem. Unit-3 L2 topic- "Introduction to Research"
It contains topics:
1. Introduction to Research
2. Need for Research
3. Need for Design Experiments
4. Experimental Design Techniques
5. Plagiarism
The document discusses data and safety monitoring boards (DSMBs), which regularly review accumulating data from ongoing clinical trials to monitor safety and scientific validity. A DSMB is typically appointed by the trial sponsor. The document outlines factors in determining if a trial needs a DSMB, how DSMBs are composed, their responsibilities like monitoring safety and effectiveness, and how they make recommendations to sponsors. Not all trials require independent external DSMBs, but all should have a data safety monitoring plan to protect participants.
This presentation contains basics of Drugs & Cosmetics Act. All the legal definitions, objective and various schedules belonging to the act are mentioned. This is the first part of Drugs & Cosmetics Act, other parts of the acts will be described in the next presentations.
This document provides an overview of analytical method validation. It defines validation as proving a method leads to expected results. Validation is required for analytical tests, equipment, and processes. Once validated, a method is expected to remain in control if unchanged. The document discusses types of analytical procedures that must be validated, including identification, quantitative impurity, limit tests, and assays. It also distinguishes between validation and verification. Key aspects of validation covered include system suitability, specificity, linearity, range, precision, accuracy, recovery, and robustness. The validation characteristics and acceptance criteria are defined.
The document discusses various tablet granulation techniques. It defines granulation as a process where small particles adhere together through bonding, forming larger aggregates called granules. The key granulation methods described are direct compression, dry granulation, wet granulation, and granulation by crystallization. Wet granulation is identified as the most versatile technique, imparting desirable physical properties to granules for tablet compression.
This document contains the answers to an assignment given to pharmacy students at an institute in India. It includes answers to 20 multiple choice questions about the Drug and Cosmetic Act and Rules as well as the Narcotic Drugs and Psychotropic Substances Act. It also provides detailed answers to 5 additional questions about the constitution of the Drugs Technical Advisory Board, prohibited drug advertisements, offenses and penalties under the NDPS Act, and the procedure an inspector follows for taking drug samples for analysis.
This document outlines WHO guidelines for transferring technology between an originating unit (OU) and receiving unit (RU). It discusses establishing a formal agreement and project management plan between the units. The technology transfer protocol should include objectives, key personnel, a comparison of materials/methods, and acceptance criteria. Training programs may need to be implemented. Documentation of the transfer, including a summary report, is important. The guidelines also provide recommendations for production, quality control, facilities, equipment, documentation, and qualification/validation activities to ensure a successful technology transfer.
The document discusses ICH stability guidelines for pharmaceutical products. It provides an overview of key ICH guidelines including Q1A(R2) on stability testing of new drug substances and products and Q1B on photo stability testing. Q1A(R2) outlines the core stability data package required, including testing conditions, number of batches, and stability commitments. It also defines criteria for significant changes. Q1B covers photo stability testing conditions and study design. The guidelines aim to provide stability information for marketing applications and ensure quality, safety and efficacy over the shelf life of pharmaceutical products.
The document discusses guidelines for clinical trial protocols according to various regulatory agencies. It provides definitions of a protocol, describes common components of protocols such as objectives, study design, and safety assessments. It also outlines regulatory requirements for bioequivalence studies from agencies like FDA, EMA, and CDSCO regarding issues like study design, sample size, acceptance criteria, product handling and more. Requirements for conducting fed and fasting studies are also covered.
Minitab is statistical software that allows users to enter and analyze data quickly through various menus like File, Edit, Data, Calc, Stat, Graph, and Help. It has two windows - the session window displays analysis outputs while the worksheet window enters data into columns. Descriptive statistics like mean, standard deviation, median, minimum, and maximum values can be viewed for data sets by selecting them from the Display Descriptive Statistics window in the Stat-Basic Statistics menu. Histograms can also be created to graphically represent data by selecting Histogram from the Graph menu and choosing the simple graph type and relevant data set.
The document outlines the organization of the Common Technical Document (CTD), which harmonizes the electronic submission of information for drug registration. The CTD includes five modules: Module 1 contains region-specific administrative information; Module 2 provides overviews and summaries of Modules 3-5; Module 3 covers quality topics; Module 4 addresses nonclinical safety studies; and Module 5 concerns clinical efficacy studies. The document describes the content and order recommended for each module to ensure a standardized presentation and review of information.
Stability Testing for Drug Substances and Drug ProductsMaher Al absi
Stability testing is conducted to determine the shelf life and storage conditions of drug substances and products. Factors that can affect drug stability include oxygen, water, temperature, pH, humidity, light, physical form, excipients, and processing methods. Degradation can result in lowered potency, toxic products, or changes in appearance and bioavailability. International guidelines provide recommendations for stability testing protocols, including those from ICH, WHO, ASEAN, and EMEA. Testing conditions vary based on the climatic zone, and labeling statements specify where stability has been demonstrated and any storage requirements. A variety of attributes are tested over time, including appearance, assay, degradation products, dissolution, and moisture content.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Shelf Life of Indian System of Medicine (ISM).pptxChhavi Singh
The document discusses self life and stability studies of formulations in Indian Systems of Medicine (ISM). It provides background on the three main systems of ISM - Ayurveda, Siddha, and Unani. It then discusses the importance of stability testing and shelf life determination to ensure safety and efficacy of ISM products over time. Key concepts from classical ISM texts on shelf life are presented. Guidelines for conducting stability studies outlined in the Ayurvedic Pharmacopoeia of India are summarized, including storage conditions, testing methods, evaluation criteria and protocols.
This document provides information on guidelines for evaluating the quality of herbal drugs according to WHO and ICH guidelines. It discusses key steps in ensuring quality such as identification of herbal drugs, assessing purity and safety, and ensuring efficacy. Specific tests and studies recommended by the guidelines are outlined such as physicochemical evaluation, determining toxic content and microbial contamination. The roles of ICH guidelines in quality, safety, and efficacy evaluation of herbal drugs are described. Guidelines for stability testing of herbal drugs to determine shelf-life are also summarized.
This document discusses bioequivalence standards for highly variable drug products. It begins by defining highly variable drug substances and products as those with intra-subject variabilities greater than 30%. It notes the sources of high variability can include administration conditions, physiological factors, and technical aspects. The usual standards for passing bioequivalence require average AUC and Cmax values to fall within 80-125% intervals. However, these criteria may be impossible to meet for highly variable drugs even with large sample sizes. The document therefore proposes alternative approaches for demonstrating bioequivalence of highly variable drugs, including replicate study designs and reference scaled average bioequivalence criteria. It provides examples and discusses some issues that can arise with these alternative approaches.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
The document presents an overview of ICH guidelines. It discusses that ICH was created in 1990 to harmonize pharmaceutical regulations between Europe, Japan, and the US. ICH has developed over 45 guidelines divided into quality, safety, efficacy, and multidisciplinary categories. The quality guidelines address chemical and pharmaceutical quality assurance. The safety guidelines cover preclinical safety testing. The efficacy guidelines relate to clinical trial design, conduct, and reporting. The multidisciplinary guidelines cover topics that do not fit uniquely into the other categories. In summary, the document provides a high-level introduction to the structure and guidelines of the International Council for Harmonisation.
This document summarizes guidelines for stability testing of biotechnological and biological products. It discusses factors that can affect stability, including temperature, humidity, light and container materials. The guidelines specify conducting real-time stability studies at the proposed storage temperature and testing potency, purity and degradation over time. Manufacturers must propose a stability-indicating profile and validate methods to detect any changes to the identity, purity or potency of the product.
The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
This document provides an overview of the ICH Q1A(R2) guideline for stability testing of new drug substances and products. The guideline defines the stability data package required for drug registration in major regions. It addresses testing timelines and conditions for long term, intermediate, and accelerated studies on at least three batches of drug substance and product. The goal is to establish a re-test period or shelf life and recommended storage conditions. Specifications must cover attributes susceptible to change that could impact quality, safety or efficacy. The guideline provides detailed recommendations for testing frequency, storage conditions, and evaluation of results.
Introduction to Research - Biostatistics and Research methodology 8th Sem Uni...Himanshu Sharma
This slide contains B.Pharm Biostatistics and Research methodology 8th Sem. Unit-3 L2 topic- "Introduction to Research"
It contains topics:
1. Introduction to Research
2. Need for Research
3. Need for Design Experiments
4. Experimental Design Techniques
5. Plagiarism
The document discusses data and safety monitoring boards (DSMBs), which regularly review accumulating data from ongoing clinical trials to monitor safety and scientific validity. A DSMB is typically appointed by the trial sponsor. The document outlines factors in determining if a trial needs a DSMB, how DSMBs are composed, their responsibilities like monitoring safety and effectiveness, and how they make recommendations to sponsors. Not all trials require independent external DSMBs, but all should have a data safety monitoring plan to protect participants.
This presentation contains basics of Drugs & Cosmetics Act. All the legal definitions, objective and various schedules belonging to the act are mentioned. This is the first part of Drugs & Cosmetics Act, other parts of the acts will be described in the next presentations.
This document provides an overview of analytical method validation. It defines validation as proving a method leads to expected results. Validation is required for analytical tests, equipment, and processes. Once validated, a method is expected to remain in control if unchanged. The document discusses types of analytical procedures that must be validated, including identification, quantitative impurity, limit tests, and assays. It also distinguishes between validation and verification. Key aspects of validation covered include system suitability, specificity, linearity, range, precision, accuracy, recovery, and robustness. The validation characteristics and acceptance criteria are defined.
The document discusses various tablet granulation techniques. It defines granulation as a process where small particles adhere together through bonding, forming larger aggregates called granules. The key granulation methods described are direct compression, dry granulation, wet granulation, and granulation by crystallization. Wet granulation is identified as the most versatile technique, imparting desirable physical properties to granules for tablet compression.
This document contains the answers to an assignment given to pharmacy students at an institute in India. It includes answers to 20 multiple choice questions about the Drug and Cosmetic Act and Rules as well as the Narcotic Drugs and Psychotropic Substances Act. It also provides detailed answers to 5 additional questions about the constitution of the Drugs Technical Advisory Board, prohibited drug advertisements, offenses and penalties under the NDPS Act, and the procedure an inspector follows for taking drug samples for analysis.
This document outlines WHO guidelines for transferring technology between an originating unit (OU) and receiving unit (RU). It discusses establishing a formal agreement and project management plan between the units. The technology transfer protocol should include objectives, key personnel, a comparison of materials/methods, and acceptance criteria. Training programs may need to be implemented. Documentation of the transfer, including a summary report, is important. The guidelines also provide recommendations for production, quality control, facilities, equipment, documentation, and qualification/validation activities to ensure a successful technology transfer.
The document discusses ICH stability guidelines for pharmaceutical products. It provides an overview of key ICH guidelines including Q1A(R2) on stability testing of new drug substances and products and Q1B on photo stability testing. Q1A(R2) outlines the core stability data package required, including testing conditions, number of batches, and stability commitments. It also defines criteria for significant changes. Q1B covers photo stability testing conditions and study design. The guidelines aim to provide stability information for marketing applications and ensure quality, safety and efficacy over the shelf life of pharmaceutical products.
The document discusses guidelines for clinical trial protocols according to various regulatory agencies. It provides definitions of a protocol, describes common components of protocols such as objectives, study design, and safety assessments. It also outlines regulatory requirements for bioequivalence studies from agencies like FDA, EMA, and CDSCO regarding issues like study design, sample size, acceptance criteria, product handling and more. Requirements for conducting fed and fasting studies are also covered.
Minitab is statistical software that allows users to enter and analyze data quickly through various menus like File, Edit, Data, Calc, Stat, Graph, and Help. It has two windows - the session window displays analysis outputs while the worksheet window enters data into columns. Descriptive statistics like mean, standard deviation, median, minimum, and maximum values can be viewed for data sets by selecting them from the Display Descriptive Statistics window in the Stat-Basic Statistics menu. Histograms can also be created to graphically represent data by selecting Histogram from the Graph menu and choosing the simple graph type and relevant data set.
The document outlines the organization of the Common Technical Document (CTD), which harmonizes the electronic submission of information for drug registration. The CTD includes five modules: Module 1 contains region-specific administrative information; Module 2 provides overviews and summaries of Modules 3-5; Module 3 covers quality topics; Module 4 addresses nonclinical safety studies; and Module 5 concerns clinical efficacy studies. The document describes the content and order recommended for each module to ensure a standardized presentation and review of information.
Stability Testing for Drug Substances and Drug ProductsMaher Al absi
Stability testing is conducted to determine the shelf life and storage conditions of drug substances and products. Factors that can affect drug stability include oxygen, water, temperature, pH, humidity, light, physical form, excipients, and processing methods. Degradation can result in lowered potency, toxic products, or changes in appearance and bioavailability. International guidelines provide recommendations for stability testing protocols, including those from ICH, WHO, ASEAN, and EMEA. Testing conditions vary based on the climatic zone, and labeling statements specify where stability has been demonstrated and any storage requirements. A variety of attributes are tested over time, including appearance, assay, degradation products, dissolution, and moisture content.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Shelf Life of Indian System of Medicine (ISM).pptxChhavi Singh
The document discusses self life and stability studies of formulations in Indian Systems of Medicine (ISM). It provides background on the three main systems of ISM - Ayurveda, Siddha, and Unani. It then discusses the importance of stability testing and shelf life determination to ensure safety and efficacy of ISM products over time. Key concepts from classical ISM texts on shelf life are presented. Guidelines for conducting stability studies outlined in the Ayurvedic Pharmacopoeia of India are summarized, including storage conditions, testing methods, evaluation criteria and protocols.
This document provides information on guidelines for evaluating the quality of herbal drugs according to WHO and ICH guidelines. It discusses key steps in ensuring quality such as identification of herbal drugs, assessing purity and safety, and ensuring efficacy. Specific tests and studies recommended by the guidelines are outlined such as physicochemical evaluation, determining toxic content and microbial contamination. The roles of ICH guidelines in quality, safety, and efficacy evaluation of herbal drugs are described. Guidelines for stability testing of herbal drugs to determine shelf-life are also summarized.
Stability testing and shelf life estimationManish sharma
Drug stability refers to the extent to which a pharmaceutical product retains its quality attributes, such as concentration of active ingredients, over time. Stability testing is necessary to determine a drug's shelf life and recommended storage conditions. It involves evaluating a drug's chemical, physical, and microbial properties under different temperatures and humidity levels over time. The Arrhenius equation can be used to predict a drug's stability at normal temperatures based on its degradation rates observed during accelerated stability testing at elevated temperatures. International guidelines provide recommendations for long-term and accelerated stability study protocols and minimum data requirements for drug substances and products to ensure quality, safety and efficacy over a product's shelf life.
The document discusses guidelines for stability testing of pharmaceutical products. It defines stability testing as evaluating how environmental factors affect a drug substance or product's properties over time. This helps determine shelf life, proper storage conditions, and labeling instructions. Stability testing evaluates many factors like active ingredient stability, excipient interactions, manufacturing process, dosage form, and storage conditions. It also considers degradation reactions and how they are impacted by conditions. Stability testing parameters and timepoints are described for various dosage forms like tablets, capsules, solutions, injections etc. The document also discusses ICH guidelines for stability testing and recommendations for climatic zones III and IV.
shelf life and Stability test for Ayurvedic drugs.pptxANIKETH SURVE
This document discusses shelf life and stability studies for Ayurvedic medicines. It provides guidelines on determining shelf life based on real-time stability studies as specified in the Ayurvedic Pharmacopoeia of India. Key factors that affect shelf life are discussed such as derivation of the drug, dosage form, environmental factors, and storage conditions. Specific shelf life guidelines are provided for different categories of Ayurvedic medicines based on their composition. The purpose and approaches to stability testing are explained to establish a retest period or shelf life. Testing frequency, storage conditions, evaluation criteria and what constitutes a significant change are also outlined.
The document discusses the importance of stability studies for pharmaceutical products. It defines stability as the extent to which a drug substance or product retains its properties within specified limits throughout its shelf life. Stability studies are important for determining shelf life, identifying optimal storage conditions, and ensuring drug efficacy and safety. The key factors that can affect drug stability are temperature, moisture, light, pH, concentration, and drug interactions. The document also discusses the different types of stability, including physical, chemical, and microbiological stability. It outlines the various regulations and guidelines for conducting stability studies.
This document discusses stability testing and guidelines for conducting stability studies. It provides definitions and purposes of stability testing, including determining a product's shelf life and suitable storage conditions. Key points:
- Stability testing involves studying how a drug's quality changes over time under environmental factors like temperature, humidity, and light.
- Studies are conducted according to ICH guidelines and involve long-term, accelerated, and intermediate storage conditions on multiple batches.
- Results provide evidence for a retest period or shelf life. Significant changes observed during testing may require adjusting the proposed shelf life.
- Guidelines cover topics like selection of batches, containers, testing frequency, evaluation of results, and data presentation required in applications. Matrix
ICH STABILITY TESTING GUIDELINES (ICH Q1A-Q1F).pptxDurgadevi Ganesan
ICH Stability Testing Guidelines: ICH Q1A-Q1F (Q1 series)
Q1A(R2): STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1B: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1C: STABILITY TESTING FOR NEW DOSAGE FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E: EVALUATION OF STABILITY DATA
Q1F: STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III & IV
This document discusses drug research in Ayurveda. It outlines the major areas of Ayurvedic research including literary, fundamental, drug, pharmaceutical, and clinical. It describes the various stages and methods of drug research in Ayurveda, including literary study, fieldwork, testing drugs, toxicity studies, and efficacy studies. The document emphasizes that drug identification and standardization are important aspects of research and validation of Ayurvedic knowledge. It provides the example of Guggulu to illustrate how following Ayurvedic principles can help discover useful drugs and validates techniques like purification methods.
The document discusses the importance of stability studies for pharmaceutical products to determine shelf-life and ensure quality, safety, and efficacy over time. It outlines regulatory guidelines for stability testing, including storage conditions and frequencies of analysis. The interpretation of stability study results and conclusion that testing must be done according to specifications throughout a product's shelf-life are also summarized.
The document summarizes ICH guidelines for stability studies of new drug substances and products. It discusses the objectives and scope of stability testing, including providing evidence of a drug's quality over time under various environmental conditions to establish storage requirements and shelf life. The types of stability testing include chemical, physical, microbiological, therapeutic, and toxicological. Testing is conducted over various time periods and storage conditions as outlined in the ICH Q1A-Q1F guidelines. Evaluation of stability data includes assessing parameter results and using statistical analyses to determine a product's retest period or shelf life.
This document provides an overview of stability studies, including the basic concepts, objectives, factors affecting stability, types of stability studies, ICH guidelines, climatic zones, steps for stability testing, and a reference. It defines stability as a drug substance or product retaining its properties and characteristics within specifications for a given time period. The objectives of stability testing are to determine shelf life and storage conditions, ensure formulation and packaging adequacy, understand quality variations over time, and prevent recalls. ICH guidelines cover testing requirements. Studies include long-term, accelerated, and intermediate testing under various climatic zone storage conditions.
1. Drug stability testing involves conducting studies under various temperature, humidity and light conditions to determine a drug's shelf life and optimal storage requirements.
2. The ICH Q1A guideline provides the standard process for stability testing new drug substances and products to obtain registration. It defines testing stages, storage conditions and frequencies to evaluate how quality varies over time.
3. Stability testing helps establish expiration dates and provides evidence for appropriate packaging and labeling to ensure drug quality through a product's shelf life.
Bioavailability and bioequivalence are important concepts for regulating generic drugs. Bioavailability refers to the rate and extent that the active drug ingredient is absorbed and available in the body. Bioequivalence means two drug products containing the same active ingredient have the same rate and extent of absorption. For approval, generic drugs must demonstrate bioequivalence to the brand name drug through pharmacokinetic studies comparing metrics like AUC and Cmax between a test and reference drug. The FDA prefers showing bioequivalence through these types of studies using a crossover design in healthy subjects under fasted conditions.
Dr. Sujit Kumar MD Storage Condition and Stability of Ayurvedic Medicines pptDR. SUJIT KUMAR
This document discusses factors that impact the shelf life and stability of Ayurvedic drugs, including packaging, storage conditions, and labeling requirements. It notes that Ayurvedic texts classify drugs and provide guidance on their ideal storage periods. Specifically, it states that powders typically last 3 months, pills up to 12 months, and oils and fats up to 16 months. The document also outlines temperature, moisture, light, and packaging as key influences on drug degradation and recommends following good manufacturing practices and quality control to maximize drug stability and ensure safety.
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for different dosage forms. It provides details on common quality control tests for tablets, capsules, creams, ointments, and suppositories during manufacturing. For tablets, tests like hardness, friability, weight variation, and dissolution are described. For capsules, weight variation, content uniformity, and moisture permeation tests are covered. Quality tests for creams and ointments include assessment of physical properties, pH, spreadability, and microbial growth testing. Suppository quality tests include uniformity of weight, melting range, visual examination, dissolution, and disintegration.
Stability testing of herbal products involves subjecting samples to various conditions like heat, light, and humidity to determine shelf life and ensure quality over time. Key aspects of stability testing include establishing acceptance criteria and storage conditions, conducting both accelerated and long-term real-time tests, and developing a protocol that specifies test attributes, analytical methods, sampling plans, and evaluation procedures. Challenges with testing herbal products relate to their complex compositions, but can be addressed through marker analyses and fingerprinting techniques. Proper stability testing is important for determining appropriate packaging, storage, and expiry dates.
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• Pitfalls and pivots needed to use AI effectively in public health
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Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
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We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
Presentation on stability study
1.
2. STABILITY STUDIES WITH SPECIAL
REFERENCE TO UNANI MEDICINE
Presented By
Md. Naquibuddin
(P.G Scholar)
Under the guidanceof,
Dr. Khaleequr Rahman
(Lecturer)
DEPARTMENT OF ILMUL SAIDLA
NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE
3. Introduction
• Nothing in this universe is immortal, all things
that have form eventually decay.
• Medicinal products also degrade with time
thus significance and indispensability of
stability testing in development of dosage
forms/formulation is well recognized.
• Stability testing is necessary to ensure that the
product is of acceptable quality throughout its
entire storage period.
4. • The purpose of stability testing is to provide
evidence on how the quality of a drug substance
varies with time under the influence of various
environmental factors.
• Recent efforts by the International Conference on
Harmonization with regard to stability have
brought an increased regulatory scrutiny at very
low level.
• Ministry of Health and Family Welfare, Dept. of
AYUSH also admitted that the potency of ASU
preparations looses/reduces after a certain
period of time. Hence display of expiry date on
container or package has been made mandatory.
5.
6. • Unani literature describes shelf life as that period
within which the drug is able to keep its
temperament, constituents and structural
constitution in equilibrium, which may be judged
by means of observing its organoleptic
characteristics.
• Until these characteristics are intact the drug is
said to be stable, and in case of any deviation it is
assumed that the drug has lost its stability.
• The first person to mention about stability OF
DRUG was none other than Buqrat (460-377BC).
He stated that if gum is added to marham
(ointment) it remains stable for about twenty
years.
7. Unani literature displays stability of
different plant parts as:
• Flowers and leaves: They remain stable for 6
months and after one year are considered
useless, but in case of proper storage their
stability can be maintained for two years.
• Fruits: These remain stable only up to their
respective seasons and even less, bahi (Pyrus
communis), unnab (Zizyphus sativus) and other
watery fruits do remain stable for only one
month, but those with less oil content can be
used for two to three years.
8. • Seeds: Depending upon the content of oil and
fats seeds remain stable for more or less
duration, those with less oil load like zeera
(Carum carvi), badiyan (Foeniculum vulgare)
retain their life for 2 to 3 years and those with
more oil and fat content like tukhme
khashkhash (Papaver somniferum) and
tukhme tarbooz (Citrullus vulgaris) remain
stable for not more than a year.
• Kernels: Like akhrot (Jugulans regia), badam
(Prunus amygdalus) and chilghoza (Pinus
gerardiana) remain stable for about a year.
9. • Branches, barks and roots: Their stability varies
from plant to plant and characters like their
hardness, softness, solid or spongy attributes
which are leading factors responsible for duration
of their stability. Roots like that of adrak (Zingiber
officinale), chobchini (Smilax china), narkachur
(Zingiber zerumbet) and sheqaqul misri
(Pastinaca secacul) remain potent for a year while
those of qust (Saussurea lappa) and waj turki
(Acorus calamus) remain stable for 10 years. As
far as barks like darchini (Cinnamomum cassia)
and taj (Cinnamomum tamala) are concerned,
their shelf life has been noted down as 2 years
which is the average shelf life of barks. But there
may be variation depending upon amount of
moisture content.
10. • Gums: Like gonde kateera (Cochlosperum religiosum),
luk (Coccus lacca), and dammul akhwain (Dracaena
cinnabari) have shelf life up to 3 years which is usual
age of gums.
• Extracts: Their age is up to 2 years like that of rasaut
(Berberis aristata), aqaqiya (Acacia arabica) etc.
• Oils: They being liable to decomposition and rancidity
have less shelf life. Oils with barid mizaj like roghane
kaddu, roghane kahu and roghane khashkhash are less
stable than those roghaniyat, which are having haar
mizaj like roghane zaitoon, roghane kunjad, roghane
kataan and roghane balsan which remain stable for
about 2 years. Among haar roghaniyat, roghane balsan
stands at top in terms of retaining shelf life and as for
as roghane zaitoon is concerned its age is said to
increase with time and can remain potent for 4 years.
11. Drugs and Cosmetics (Amendment)
Rules, 2005
• "161B: - The date of expiry of Ayurveda,
Siddha and Unani (ASU) medicines shall be
conspicuously displayed on the label of
container or package of an Ayurvedic, Siddhas
and Unani drugs, after which they shall not be
in circulation. Shelf-life for Ayurveda, Siddha &
Unani (ASU) medicines shall be as follows:
12. Shelf life or expiry date for Unani
System of Medicines
S.No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Name of the Group of Medicine
Habb (Pills)
Qurs (Tablets)
Majoon / Dawa
Khamira
Itrifal
Tiryaq
Laooq
Laboob
Halwa
Mufarreh / Yaqooti
Burood / Surma / Kohal
Kushta
Raughaniyat
Marham / Zimad / Qairooti
Ayarij / Sufoof
Safoof (Namak wala / containing salt)
Shelf life / Expiry date
2 Years
2 Years
2 Years
2 Years
3 Years
2 Years
1 Year
1 Year
1 Year
2 Years
3 Years
5 Kushta
2 Years
2 Years
1 Years
6 Months
13. S.No.
17.
18.
19.
20.
21.
22.
23
24.
Name of the Group of Medicine
Sharbat / Sikanjabeen
Jawarish
Capsule
Arq
Qutoor
Nabeez
Murabba
Tila
Shelf life / Expiry date
2 Years
2 Years
2 Years
1 Year
1 Year
5 Years
1 Year
2 Years
14. • Note: The principal rules were published in
the Gazette of India, vide, Notification
number F.29-10/45-H dated 21.12.1945 and
last amendment vide number G.S.R. 664,
dated 14.11.2005.
15. Controversy in Shelf life mention in
Classical literature and D & C rule.
• Shelf life mention in classical literature were evaluated
only on subjective parameter or parameters available
in those time, which may not qualify present scientific
methods.
• Shelf life mentioned in D & C rule are abstract of
various textual references.
• Shelf life mentioned in D & C rule are based on dosage
form.
Where as it is the responsibility of manufacturer to asses
shelf life of their products. Shelf life of a drug product
may vary from manufacturer to manufacturer or
industry t industry.
16.
17. Stability
• The capacity or the capability of a particular
formulation in a specific container to remain
with in particular chemical, microbiological,
therapeutically, and toxicological specifications.
Or
• Extent to which a product retains with in
specified limits and throughout its period of
storage and use ( i.e. shelf life). (USP)
18. • Stability is officially defined as the time during
which the drug product retains the same
properties and characteristics that it possessed at
the time of manufacture.
• Drug stability refers to the capacity of a drug
substance or product to remain within established
specifications of identity, strength, quality, and
purity in a specified period of time.
19. Stability studies are incorporated at all stages of drug product life cycle from
early stages of product development to late stage follow-up stabilities. In
particular the life cycle can be segregated into 6 different stages.
• Stage 1- Early stage stress and accelerated testing
with drug substances.
• Stage 2- Stability on pre-formulation batches. (Pilot
Batch)
• Stage 3- Stress testing on scale-up batches. (Regular
production batch)
• Stage 4- Accelerated and long term testing for
registration purposes.
• STAGE 5- On-going stability testing.
• STAGE 6- Follow-up Stabilities.
20. Regulations and Guidances
• The ICH (International Conference on
Harmonization) Guidelines Q1A(R2) “Stability
testing of new drug substances and products” is
the “gold standard” for conducting stability
studies. This is valid for “new drug substances or
drug products” that are sufficient for a registration
application.
21. ICH GUIDELINES FOR STABILITY
STUDIES
• Q1A- Stability testing of new Drug
Substances and Products.
• Q1B- Stability Testing : Photo stability
Testing of New Drug Substances and
products.
• Q1C- Stability Testing for new Dosage
forms.
• Q1D- Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances
and products.
• Q1E- Evaluation of stability data.
• Q1F- Stability data package for registration
22. Why Stability studies are necessary ?
• Chemical degradation of the product leads to
lowering of the concentration of the drug in
the dosage form.
• Toxic products may be formed, due to
chemical degradation of the active ingredient.
23. Advantages of Stability studies
• Assurance to the patient
• Economic considerations
• Legal requirement.
24. OBJECTIVE OF STABILITY STUDY
• To determine maximum expiration date/ shelf
life.
• To gather information during pre-formulation
stage to produce a stable product.
• To provide better storage condition.
• To determine the packaging components.
• To establish retest period of pharmaceuticals.
• To establish transport condition.
25. Factors affecting Drug Stability
• Storage condition.
• Interaction between the API and excipient.
• Formulation Development.
• Selection of dosage form.
• Manufacturing process of drug product.
• Selection of container closure packaging
system.
26. • Effect of storage (temperature, humidity and
light).
• Selection of marketing image.
• Handling of the finished products.
27. Types
• Three types of Stability Studies
• Accelerated
Studies designed to know the short term Excursions of
temperature on the drug Substances.
• Intermediate
Studies conducted, incase of failure in accelerated
studies and the conditions of temperature and humidity
are in between long term and accelerated.
• Long term
Studies designed to check the stability of the drug
substnace.
28. Stability Protocol
Study Storage Condition
Minimum time
period covered by
data at submission
Long term
(Ambient)
25o C ± 2o C
60%RH ± 5%
12 Months
Intermediate
(Controlled)
30o C ± 2o C
60%RH ± 5%
6 Months
Accelerated 40o C ± 2o C
75%RH ± 5%
6 Months
29.
30. LONG TERM STUDY
• Frequency of testing in case of long-term
study should normally be every three months
over the first year, every six months over the
second year and annually thereafter.
31. ACCELERATED STUDY
• In case of accelerated study a minimum of
three time points including the initial and final
time point is necessary e.g 0, 3 and 6 months
33. TYPES OF STABILITY THAT MUST BE
CONSIDERED FOR ANY DRUG
• Physical Stability:
– It includes appearance, palatability ,uniformity
,dissolution and suspendability etc.
• Chemical Stability
– Each active ingredient retains its chemical integrity
and labeled potency within the specified limit.
• Microbiological Stability
– Retained according to specified requirement.
• Therapeutical stability
– Therapeutic activity remains unchanged.
• Toxocologic Stability
– No significant increase in toxicity occurs.
34. TYPES OF STABILITY THAT MUST BE
CONSIDERED FOR UNANI DRUGS
• Alternative medicine drugs are based on multi
component, hence only chemical stability
evaluation even using marker compound is
not sufficient.
• Therefore, apart from physical and microbial
characters, therapeutical stability to confirm
whether therapeutic activity remains
unchanged, is the most important stability
parameter.
35. Limits for degradation
• The question of how much degradation is
acceptable has been the topic of many
discussions amongst pharmaceutical scientists.
Degradation of drug substances between 5% and
20% has been accepted by pharmaceutical
scientist.
• Most of the pharmaceutical scientists think 10%
degradation is acceptable for pharmaceutical
molecules and stability limits of 90% of label
claim is common.
36. The ICH guideline fixed only 5% variation limit,
that is most stringent stability guideline.
• No such limits for physiochemical changes,
loss of activity or degradation during shelf life
have been established for some individual
types or groups of biological products.
• Till date no reliable stability data were
generated for alternative medicine drugs
hence no such limit are fixed for the same.
• However limitations mentioned in stability
guidelines for modern medicine may be used.
37. INTERPRETATION
• Joel Devis rule: If drug is stable for 3 month at
40oC and 75% RH its stability period is equivalent
to 24 month at 25 C.
• As per the shelf life recommendation for
supplement if product is stored 10oC above the
room temperature for a specific period its shelf
life will be estimated as 2x storage time duration.
• Grimm’s statement:
= 3.3x period of accelerated stability condition.