This document summarizes guidelines for stability testing of drugs and pharmaceutical products. It discusses how stability testing provides evidence on how a drug's quality varies over time under different environmental conditions, and enables establishing a shelf life. Key aspects covered include variables affecting stability, types of stability testing, ICH guidelines for stability testing terminology and procedures, storage conditions for long-term and accelerated testing, and evaluation of stability data. The goal of stability testing is to ensure drug quality is maintained throughout the proposed shelf life.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
stability tests for pharmaceutical productsalaaalfayez
These documents provide guidance on stability testing and evaluation for pharmaceutical products. The purpose of stability testing is to provide evidence on how a drug product's quality varies over time under various environmental conditions. Key aspects addressed include testing the drug substance and finished product under different timepoints and storage conditions to establish or extend a product's shelf life. The documents outline best practices for conducting long-term, accelerated, and intermediate stability studies to evaluate the impact of factors like temperature, humidity, and light on a product's physical, chemical, biological, and microbiological properties over time.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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.
The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
stability tests for pharmaceutical productsalaaalfayez
These documents provide guidance on stability testing and evaluation for pharmaceutical products. The purpose of stability testing is to provide evidence on how a drug product's quality varies over time under various environmental conditions. Key aspects addressed include testing the drug substance and finished product under different timepoints and storage conditions to establish or extend a product's shelf life. The documents outline best practices for conducting long-term, accelerated, and intermediate stability studies to evaluate the impact of factors like temperature, humidity, and light on a product's physical, chemical, biological, and microbiological properties over time.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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.
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The main objectives of QbD are to ensure quality products by combining prior knowledge with new data to identify critical quality attributes and critical process parameters, and establish a control strategy within a design space. This approach helps provide a better understanding of processes and fewer batch failures through improved control and management of changes over the product lifecycle.
Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
Kinetics of Stability & Stability Testing Sidharth Mehta
This document discusses kinetics of stability and stability testing. It defines drug kinetics as how a drug changes over time and explains zero and first order reaction kinetics. Factors affecting reaction rate and types of drug degradation are covered. Stability testing is defined and its importance, types, methods, guidelines and climatic zones are summarized. Methods for estimating shelf life and determining expiration dates are also presented.
The document discusses different types of validation processes that are important for pharmaceutical manufacturing. It describes process validation, cleaning validation, equipment validation, and validation of analytical methods. Process validation ensures a process is capable of consistently producing quality products and includes prospective, concurrent, retrospective, and revalidation. Cleaning validation aims to minimize cross-contamination. Equipment validation proves equipment works correctly. Validation of analytical methods establishes that test method performance meets requirements for intended use. Government regulations require validation to ensure drug quality and safety.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
A marketed product stability program fulfills registration
commitments and ensures that marketed product is
stable until expiry date stamped on product
label....
Stability studies should be planned on the
basis of pharmaceutical R&D and regulatory
requirements...
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
Validation of cone blender, mixer granulator and tablet compression machine.MayuriGhavate
The document summarizes the validation process for common pharmaceutical equipment used in powder blending, granulation, and tablet compression. It discusses the validation of cone blenders, mixers, granulators, and tablet compression machines. The validation process involves design qualification, installation qualification, operational qualification, and performance qualification to ensure equipment is properly designed, installed, operated, and performs as intended. Key aspects that are validated include design criteria, utilities, cleaning procedures, operating parameters, and finished product quality attributes. Validation helps improve safety, reproducibility, and compliance for pharmaceutical manufacturing.
Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document discusses in-process quality control (IPQC) tests for ointments. It describes IPQC as the process of controlling quality parameters during manufacturing from raw materials to final packaging. It then lists and describes 11 common IPQC tests conducted on ointments, including tests for appearance, drug content, pH, sensitivity, spreadability, absorption rate, extrudability, sterility, viscosity, medicament release rate, and uniformity of weight. The tests are designed to ensure the quality, safety and efficacy of ointment products during production.
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 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
This document discusses different types of validation processes that are important in the pharmaceutical industry. It describes:
1) Analytical method validation, which proves that analytical methods used for testing are suitable for their intended purpose. This includes validation of accuracy, precision, repeatability, reproducibility, and other quality attributes.
2) Equipment validation to ensure equipment functions as intended, including installation qualification, operational qualification, design qualification, and performance qualification.
3) Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product batches.
4) Process validation including prospective, concurrent, retrospective, and re-validation to demonstrate manufacturing processes can consistently produce products meeting specifications.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science. The main objectives of QbD are to ensure quality products by combining prior knowledge with new data to identify critical quality attributes and critical process parameters, and establish a control strategy within a design space. This approach helps provide a better understanding of processes and fewer batch failures through improved control and management of changes over the product lifecycle.
Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
Kinetics of Stability & Stability Testing Sidharth Mehta
This document discusses kinetics of stability and stability testing. It defines drug kinetics as how a drug changes over time and explains zero and first order reaction kinetics. Factors affecting reaction rate and types of drug degradation are covered. Stability testing is defined and its importance, types, methods, guidelines and climatic zones are summarized. Methods for estimating shelf life and determining expiration dates are also presented.
The document discusses different types of validation processes that are important for pharmaceutical manufacturing. It describes process validation, cleaning validation, equipment validation, and validation of analytical methods. Process validation ensures a process is capable of consistently producing quality products and includes prospective, concurrent, retrospective, and revalidation. Cleaning validation aims to minimize cross-contamination. Equipment validation proves equipment works correctly. Validation of analytical methods establishes that test method performance meets requirements for intended use. Government regulations require validation to ensure drug quality and safety.
Distribution records document the transfer of drug products from manufacturers to distributors and must include information such as product name and strength, manufacturer, lot number, quantity shipped, and recipient. They allow defective products to be recalled and ensure accountability. Records should contain sections for product information, transaction details, distribution information, and recipient information according to WHO guidelines. An example distribution record format was also presented.
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
A marketed product stability program fulfills registration
commitments and ensures that marketed product is
stable until expiry date stamped on product
label....
Stability studies should be planned on the
basis of pharmaceutical R&D and regulatory
requirements...
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
Validation of cone blender, mixer granulator and tablet compression machine.MayuriGhavate
The document summarizes the validation process for common pharmaceutical equipment used in powder blending, granulation, and tablet compression. It discusses the validation of cone blenders, mixers, granulators, and tablet compression machines. The validation process involves design qualification, installation qualification, operational qualification, and performance qualification to ensure equipment is properly designed, installed, operated, and performs as intended. Key aspects that are validated include design criteria, utilities, cleaning procedures, operating parameters, and finished product quality attributes. Validation helps improve safety, reproducibility, and compliance for pharmaceutical manufacturing.
Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document discusses in-process quality control (IPQC) tests for ointments. It describes IPQC as the process of controlling quality parameters during manufacturing from raw materials to final packaging. It then lists and describes 11 common IPQC tests conducted on ointments, including tests for appearance, drug content, pH, sensitivity, spreadability, absorption rate, extrudability, sterility, viscosity, medicament release rate, and uniformity of weight. The tests are designed to ensure the quality, safety and efficacy of ointment products during production.
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 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
The document discusses stability testing of drug substances and products. Stability testing aims to provide evidence of how a drug's quality changes over time under various environmental factors like temperature, humidity and light. It helps establish a re-test period or shelf life for the drug and recommended storage conditions. Key aspects covered include selection of batches, testing frequency and storage conditions for long-term, intermediate and accelerated stability studies as per ICH Q1A guidelines. Specifications include attributes tested and acceptance criteria.
Shivam Dubey Pharmaceutics Assignment 03: ICH Guidelines On Drug StudiesMrHotmaster1
The document summarizes ICH guidelines for stability studies of new drug substances and products. It discusses the purpose of stability testing to ensure drug quality over shelf life. Key guidelines covered include Q1A for stability testing of new drug substances and products, Q1B for photostability testing, Q1C for new dosage forms, and Q1D for bracketing and matrixing designs. The summary also discusses long term, intermediate, and accelerated storage conditions for drug substances and products, and criteria for evaluation of stability data and establishing retest periods or shelf lives.
ICH Guidelines for Stability Testing of Drug Substance and Drug Productsonalgupta200
The document discusses the objectives, scope, rationale and advantages of stability testing. It aims to provide evidence on how the quality of a drug substance or product varies over time under different environmental conditions, and to establish storage conditions, re-test periods and shelf lives. Stability testing is conducted on both drug substances and drug products to ensure safety, efficacy and quality are maintained throughout the proposed shelf life. The International Conference on Harmonisation guidelines provide recommendations for conducting stability studies.
This document discusses stability studies and testing. Stability studies are conducted to provide evidence on how the quality of a drug substance or product varies over time under the influence of environmental factors like temperature, humidity, and light. They are required to recommend storage conditions, establish retest and shelf life periods, review product quality, and meet regulatory requirements. Key aspects covered include guidelines for stability testing, types of studies (long term, intermediate, accelerated), storage conditions, specifications, testing frequency, and requirements for stability protocols, batches, and reports.
This document provides an overview of several ICH quality guidelines related to stability testing, analytical validation, impurities, specifications, and other topics. It discusses the guidelines' focus on stability testing (Q1A, B, C, D, E, F), analytical validation (Q2), and impurities (Q3A, B, C). For each guideline covered, it provides a brief high-level summary of the key aspects and requirements.
This document summarizes key ICH guidelines related to quality and stability testing. It defines key terms like drug substance, dosage form, drug product, and finished pharmaceutical product. It describes the types of studies conducted for drug substances and products under various storage conditions to establish shelf life and re-test periods. These include long term, intermediate, and accelerated studies. It also summarizes ICH guidelines on specific topics like stability testing (Q1A-Q1F), validation of analytical procedures (Q2), impurities (Q3A-Q3C), and others.
This document discusses drug stability and stability testing. It provides an overview of the objectives, scope, rationale and variables affecting drug stability. It also describes the adverse effects of drug instability and outlines the ICH guidelines for stability testing. Key aspects covered include stress testing, storage conditions for long-term, intermediate and accelerated studies, selection of batches, and container closure systems. The document emphasizes the importance of stability testing in establishing shelf-life and recommended storage conditions for drug products.
This document summarizes the presentation of ICH stability testing guidelines for new drug substances and products. It discusses the objectives, scope, general principles and guidelines for conducting stability testing of drug substances and products. The key aspects covered include selection of batches, container closure systems, specifications, testing frequency and storage conditions for long term, intermediate and accelerated stability studies. The goals of stability testing are to provide evidence of quality changes over time and establish re-test or shelf life periods under various environmental conditions.
This document summarizes guidelines from the International Conference on Harmonisation (ICH) regarding stability testing of new drug substances and products. It discusses ICH guidelines Q1A(R2) through Q1F, which provide recommendations on conducting stability studies under various storage conditions to determine appropriate re-test periods and shelf lives. The guidelines specify the types of studies, including stress testing, selection of batches, container closure systems, specifications, testing frequency, and evaluation criteria. The document outlines recommended storage conditions and minimum time periods for long-term, intermediate, and accelerated stability studies to support product registrations.
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.
The document discusses ICH guidelines for stability testing of drug substances and products. The ICH guidelines provide recommendations for conducting stability testing to establish recommended storage conditions and shelf lives. Key ICH guidelines covered include Q1A on stability testing of new drug substances and products, Q1B on photostability testing, Q1C on stability testing for new dosage forms, and Q1E on evaluation of stability data. The guidelines address good stability practices such as stress testing, selection of batches, testing frequency, storage conditions and evaluation of results.
The document discusses guidelines for stability studies and testing according to ICH. It provides an overview of different types of stability studies including real time testing, accelerated stability testing, and retained sample stability testing. The key guidelines discussed are ICH Q1A, Q1B, Q1C which provide recommendations on stability testing of drug substances, products, and dosage forms. The document also discusses parameters to evaluate stability like potency, purity and molecular characterization as well as factors like storage conditions and temperatures for biological products.
The document discusses International Council for Harmonisation (ICH) guidelines related to stability testing of drug substances and products. It provides an overview of the historical background and development of ICH. It summarizes several ICH guidelines including Q1A on stability testing, Q1B on photostability testing, Q1C on stability testing for new dosage forms, and Q1D on bracketing and matrixing designs for stability testing. It also discusses stability storage conditions, principles of ICH guidelines for stability testing, and the objectives of guidelines like Q1E on evaluation of stability data.
The document discusses guidelines for conducting stability studies on drug substances and drug products according to ICH guidelines. It provides details on the objectives and scope of stability testing, factors to consider like storage conditions and container closure systems, types of studies to perform, and statistical approaches to analyze the data. The goal is to establish retest periods for drug substances and shelf lives for drug products based on stability data from multiple batches in order to submit this information for product registration applications.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of ICH partners and guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1, which provides guidance on stability testing of new active pharmaceutical ingredients and finished pharmaceutical products. Key aspects covered in Q1 include stress testing, selection of batches, storage conditions, container closure systems, and photo stability testing. The document also discusses bracketing and matrixing designs, stability protocols and reports, and requirements for stability results and re-test periods.
This document discusses ICH guidelines for stability testing and protocols. It provides an overview of the ICH partners that develop guidelines and describes some of the key ICH guidelines related to quality, safety, and efficacy. It then focuses on ICH guideline Q1 which provides recommendations for stability testing of new active pharmaceutical ingredients and finished pharmaceutical products, including stress testing, selection of batches, storage conditions, and photo stability testing. The document also discusses bracketing and matrixing designs for stability testing and outlines what should be included in a stability protocol and report.
Ich guidelines for stability testing of biotechnological biological products (1)Dr Raj kumar Kudari
This document provides guidelines for stability testing of biotechnological and biological products. It discusses selecting representative batches of drug substance and drug product for testing, establishing a stability-indicating profile including potency, purity, and other characteristics, and testing under various storage conditions like temperature, humidity, and accelerated/stress conditions. The guidelines aim to ensure biologics maintain biological activity and avoid degradation during their intended storage period.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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2. CONTENTS-
• Introduction
• Variables affecting the stability
• Adverse effects of instability of drugs
• Stability Testing Terminologies
ICH Q1A(R2)
ICH Q1B
ICH Q1C
ICH Q1D
ICH Q1E
3. INTRODUCTION-
DRUG STABILITY-
“A measure of how pharmaceutical products
maintains its quality attribute over a time.”
STABILITY TESTING-
A process which provide evidence on how the
quality of a drug substance or drug product
varies with time under the influence of a
variety of environmental factors such as
temperature, humidity, and light, and enables
recommended storage conditions, to establish
a shelf life for the drug.
4. Variables affecting the stability-
• Formulation
• Packaging
• Site and method of manufacture
API
Finished product
• Batch size
• Batch to batch variability
Process validation
Quality risk management
• Container labeling
• Changes to product
5. ADVERSE EFFECTS OF INSTABILITY
OF DRUGS-
• Loss of active drug (e.g. aspirin hydrolysis,
oxidation of adrenaline)
• Loss of vehicle (e.g. evaporation of water from
o/w creams, evaporation of alcohol from
alcoholic mixtures)
• Loss of content uniformity (e.g. creaming of
emulsions, impaction of suspensions)
• Loss of elegance (e.g. fading of tablets and
colored solutions)
• Reduction in bioavailability (e.g. ageing of
tablets resulting in a change in dissolution
profile)
• Production of potential toxic materials (e.g.
breakdown products from drug degradation)
6. TYPES OF STABILITY
I AM
STABLE
MICROBIOLOGICAL
STABILITY
CHEMICAL
STABILITY
PHYSICAL
STABILTY TOXICOLOGIC
STABILITY
THERAPEUTICA
L STABILITY
7. TYPES OF STABILITY-
• CHEMICAL : Each active ingredient retains its
chemical integrity and labeled potency within
the specified limit.
• PHYSICAL : The physical stability properties
includes appearance, palatability, uniformity,
dissolution and suspend ability are retained.
• MICROBIOLOGICAL : Sterility or resistance to
microbial growth is retained according to
specified requirement.
• THERAPEUTIC : Therapeutic activity remains
unchanged .
• TOXICOLOGIC : No significant increase in
toxicity occurs.
8. STABILITY TESTING
Development studies-
• Characterize compatibility with common
excipients.
• Characterize stability profile of API (E.g.
susceptibility to acid, base, light, oxygen etc)
• Characterize stability profile of early
formulations (Especially susceptibility to heat,
humidity & light)
Confirmatory studies-
• Long term & accelerated studies on the
product as it is to be registered
9. ICH GUIDELINES TITLE
Q1 A Stability testing of new drug substances
and products
Q1 B Stability testing : photo stability testing of
new drug substance and products.
Q1 C Stability testing for new dosage forms
Q1 D Bracketing and matrixing designs for
stability testing of drug substances and
products
Q1 E Evaluation of stability data
Q1 F Stability Data Package for Registration
Applications in Climatic Zones III and IV
10. Q1A : Stability Testing of New Drug
Substances and Products-
• General
• Stress Testing
• Selection of Batches
• Container Closure System
• Testing Frequency
• Storage Conditions
• Stability Commitment
• Evaluation
• Statements/Labelling
11. GENERAL-
Information on the stability of the drug substance is
an integral part of the systematic approach to
stability evaluation.
STRESS TESTING-
• Main tool that predict the stability problems.
• Foundation for developing and validating
analytical methods. For an API the following
approaches may be used.
• When available, it is acceptable to provide
relevant data published in the scientific
literature to support the identified
degradation pathways and products.
12. ROLL OF STRESS TESTING-
Stress testing of the active substance can help in.
• Identification of degradants .
• Identification of degradation pathways
• Determination of which type(s) of stress affect
the molecule:
1.Oxidation-
• Typically done by placing the drug substance
in aqueous solution of hydrogen peroxide.
• Goal is significant degradation (typically 10-
30% of API)
Can identify degradants
Determine whether protective packaging is
required.
Determine if an antioxidant should be
considered for the drug product formulation.
13. Ph-
• Typically done by adding drug substance
to buffered aqueous solutions at pH
values from 1-10
• Decide if the molecule will survive
passage through the stomach
• Is enteric coating necessary?
• the drug be given by injection?
15. SELECTION OF BATCHES-
• Data from formal stability
studies should be
provided on at least three
primary batches of the
active substance.
• The batches should be
manufactured to a
minimum of pilot scale by
the same synthetic route
as, and using a method of
manufacture and
procedure that simulates
the final process to be
used for, production
batches
16. CONTAINER AND CLOSURE SYSTEM-
The stability studies should be conducted on the
active substance packaged in a container
closure system that is the same as or simulates
the packaging proposed for storage and
distribution.
17. TESTING FREQUENCY
• For long term studies:
Year 1: every 3 months
Year 2: every 6 months
Subsequent years: annually
• At accelerated storage conditions: (6 month
study) Minimum three points including t 0 and t
final,
e.g. 0 3 6
(initial) (final)
• At intermediate storage conditions: (12
month study) Four points including t 0 and t
final,
e.g. 0 6 9 12
18. STORAGE CONDITION
A drug substance should be evaluated
• To test its thermal stability
• Its sensitivity to moisture(if applicable)
• The long-term testing (minimum of 12
months) on at least 3 primary batches
at the time of submission and
• Should be continued for a period of
time sufficient to cover the proposed
re-test period.
19. STORAGE CONDITIONS
Study Storage condition Minimum time period
covered by data at
submission
In general
Long Term* (Ambient) 25º C ± 2º C
60%RH ± 5%
12 months
Intermediate**
(controlled)
30º C ± 2º C
65%RH ± 5%
6 months
Accelerated 40º C ± 2º C
75%RH ± 5%
6 months
Refrigerator
Long Term 5º C ± 3º C 12 months
Accelerate 25º C ± 2º C 60%RH ±
5%
6 months
Freezer
Long Term -20º C ± 5º C 12 months
20. EVALUATION-
• Minimum of 3 batches of drug substance is
tested.
• The degree of variability of individual batches
affects the confidence that a future production
batch will remain within specification throughout
the assigned re-test period.
STATEMENT/LABELING-
• A storage statement should be established for
the labeling based on the stability evaluation
of the active substance.
• Where applicable, specific instructions should
be provided, particularly for active substances
that cannot tolerate freezing. Terms such as
“ambient conditions” or “room temperature”
must be avoided
21. Q2B: PHOTOSTABILITY TESTING OF
NEW DRUG SUBSTANCES AND
PRODUCTS
Photo-stability testing studies include:
(Single batch)
• Test on drug substance.
• Test on exposed drug product outside the
immediate pack.
• Test on drug product in the immediate pack.
• Test on drug product in the marketing pack.
Light source-
• Option 1: Artificial daylight lamp combining
both visible & UV output similar.
• Option 2: Cool white fluorescent & near UV
lamp(320-400nm
22. Q1C: Stability Testing for New Dosage
Forms-
• This document is an annex to the ICH parent
stability guideline and addresses the
recommendations on what should be submitted
regarding stability of new dosage forms by the
owner of the original application, after the
original submission for new drug substances
and products.
• A new dosage form is defined as a drug product
which is a different pharmaceutical product
type, but contains the same active substance
as included in the existing drug product
approved by the pertinent regulatory
23. Q1d:(Bracketing and Matrixing Designs
for Stability Testing of New Drug
Substances and Products)-
BRACKETING-
• It is the design of a stability schedule such
that only samples on the extremes of
certain design factors, e.g., strength,
package size, are tested at all time points
as in a full design.
• The design assumes that the stability of
any intermediate levels is represented by
the stability of the extremes tested. Where
a range of strengths is to be tested,
bracketing is applicable if the strengths are
identical or very closely related in
25. MATRIXING-
• It is the design of a stability schedule
such that a selected subset of the total
number of possible samples for all factor
combinations is tested at a specified
time point.
• At a subsequent time point, another
subset of samples for all factor
combinations is tested.
• The design assumes that the stability of
each subset of samples tested
represents the stability of all samples at
a given time point
27. Q1E: EVALUATION OF STABILITY
DATA
Data Presentation-
• Data for all attributes should be presented
in an appropriate format (e.g., tabular,
graphical, narrative) and an evaluation of
such data should be included in the
application.
• The values of quantitative attributes at all
time points should be reported as
measured (e.g., assay as percent of label
claim).
• If a statistical analysis is performed, the
procedure used and the assumptions
underlying the model should be stated and
justified.
28. Q1F: Stability Data Package for
Registration Applications in Climatic
Zones III and IV
• Describes harmonized global stability testing
requirements in order to facilitate access to
medicines by reducing the number of
different storage conditions.
• WHO conducted a survey amongst their
member states to find consensus on
30°C/65% RH as the long term storage
conditions for hot-dry and hot-humid regions.
29. ICH Stability Zones
ZONE TYPE OF CLIMATE
Zone 1 Temperate zone
Zone 11 Subtropical/ Medititerranean Zone
Zone 111 Hot dry zone
Zone 1Va Hot humid/ Tropical zone
Zone 1Vb Hot/ Higher humidity
30. Drug Recalls
DATE BRAND NAME PRODUCT NAME
11/07/2022 Adam’s Polishes Hand Sanitizer due to potential
contamination of Methanol
10/25/2022 Aurobindo Pharma
USA, Inc.
Quinapril (20 mg) and
Hydrochlorothiazide (12.5 mg)Tablets
USP due to N-nitroso impurity
10/25/2022 Mylan Institutional LLC Octreotide Acetate Injection (500
mcg/ml) due to glass Particulates in a
Syringe
8/22/2022 Hospira Propofol Injecable Emulsiom
(Containing Benzyl Alcohol) due to
presence of Visible Particulates
4/22/2022 Pfizer ACCUPRIL(Quinapril HCL) due to N-
nitroso- quinapril content