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 (intro, scope, merits, ich, who guidelines)PRAJAKTASAWANT33
This document summarizes a presentation on validation given by Prajakta Sawant, a first year M.Pharm student at Alard College of Pharmacy in Pune, India. The presentation covered the need for validation, types of validation including process, cleaning, equipment and analytical method validation. It discussed validation concepts such as the validation master plan, documentation, and ICH and WHO guidelines. The goal of validation is to ensure consistent production of pharmaceuticals meeting quality standards.
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
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.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
Validation (intro, scope, merits, ich, who guidelines)PRAJAKTASAWANT33
This document summarizes a presentation on validation given by Prajakta Sawant, a first year M.Pharm student at Alard College of Pharmacy in Pune, India. The presentation covered the need for validation, types of validation including process, cleaning, equipment and analytical method validation. It discussed validation concepts such as the validation master plan, documentation, and ICH and WHO guidelines. The goal of validation is to ensure consistent production of pharmaceuticals meeting quality standards.
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
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.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
This document provides guidance for the preparation and submission of veterinary master files to the FDA's Center for Veterinary Medicine. It defines six types of master files, including Veterinary Master Files (VMFs) and Public Master Files. The guidance eliminates Type I VMFs, which contained information on manufacturing sites, facilities, procedures and personnel. Holders with existing Type I VMFs can request transferring information to other VMF types. The guidance describes the remaining VMF types and provides instructions for submissions, reviews, confidentiality and other procedures.
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
This document discusses process validation for tablets, capsules, and parenterals. It defines validation and process validation, and describes the key steps in manufacturing each dosage form. For tablets, these include mixing, granulation, milling, drying, compression, and coating. Parameters to validate at each step are identified. In-process and finished product tests are also outlined. Validation of capsules involves composition and encapsulation processes. Parenteral validation focuses on sterilization, manufacturing, and packaging. References on pharmaceutical process validation and specific dosage forms are provided.
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
Government regulation in pharmaceutical validationVaishnaviRaut6
This document provides an overview of government regulations for pharmaceutical validation from various regulatory bodies such as the US FDA, cGMP, WHO, EU, and PIC/S. It defines validation, discusses the importance of validation, and outlines the historical background that led to regulation. The key points are that validation became mandatory under cGMP regulations to ensure quality and minimize risk, and all major regulatory bodies now require validation studies to be conducted according to predefined protocols and provide documented evidence that processes will consistently produce quality products meeting specifications.
This document discusses different coating methods and techniques used in the pharmaceutical industry. It describes:
1) Rotating coating pans and fluidized bed coaters are commonly used to coat tablets by spraying coating solutions and evaporating the liquid. Traditional techniques include sugar coating and film coating.
2) Key steps in sugar coating include sealing, sub coating, smoothing/syrup coating and finishing. Film coating uses similar equipment and parameters as sugar coating.
3) Common coating equipment includes standard coating pans, perforated coating pans, and fluidized bed coaters. Top spray, bottom spray, and tangential spray are fluidized bed coating methods that differ in how the coating solution is applied.
4) Dry particle
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
ICH and WHO Guideline for Validation and Calibration.pptxRAHUL PAL
Validation: Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
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.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
Qualification of tablet compression machinePritam Kolge
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
This document provides guidance for the preparation and submission of veterinary master files to the FDA's Center for Veterinary Medicine. It defines six types of master files, including Veterinary Master Files (VMFs) and Public Master Files. The guidance eliminates Type I VMFs, which contained information on manufacturing sites, facilities, procedures and personnel. Holders with existing Type I VMFs can request transferring information to other VMF types. The guidance describes the remaining VMF types and provides instructions for submissions, reviews, confidentiality and other procedures.
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
This document discusses process validation for tablets, capsules, and parenterals. It defines validation and process validation, and describes the key steps in manufacturing each dosage form. For tablets, these include mixing, granulation, milling, drying, compression, and coating. Parameters to validate at each step are identified. In-process and finished product tests are also outlined. Validation of capsules involves composition and encapsulation processes. Parenteral validation focuses on sterilization, manufacturing, and packaging. References on pharmaceutical process validation and specific dosage forms are provided.
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
Government regulation in pharmaceutical validationVaishnaviRaut6
This document provides an overview of government regulations for pharmaceutical validation from various regulatory bodies such as the US FDA, cGMP, WHO, EU, and PIC/S. It defines validation, discusses the importance of validation, and outlines the historical background that led to regulation. The key points are that validation became mandatory under cGMP regulations to ensure quality and minimize risk, and all major regulatory bodies now require validation studies to be conducted according to predefined protocols and provide documented evidence that processes will consistently produce quality products meeting specifications.
This document discusses different coating methods and techniques used in the pharmaceutical industry. It describes:
1) Rotating coating pans and fluidized bed coaters are commonly used to coat tablets by spraying coating solutions and evaporating the liquid. Traditional techniques include sugar coating and film coating.
2) Key steps in sugar coating include sealing, sub coating, smoothing/syrup coating and finishing. Film coating uses similar equipment and parameters as sugar coating.
3) Common coating equipment includes standard coating pans, perforated coating pans, and fluidized bed coaters. Top spray, bottom spray, and tangential spray are fluidized bed coating methods that differ in how the coating solution is applied.
4) Dry particle
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
ICH and WHO Guideline for Validation and Calibration.pptxRAHUL PAL
Validation: Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
Objectives and policies of c gmp, layout of building and servicesSharwari Sapate
Pharmaceutical Quality affects every individual. Therefore GMP is required to ensure the quality of the particular drug or dosage form. In this presentation you will go through some basic information about cGMP and layout of buildings.
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.
The document discusses key aspects of validating solid dosage forms such as tablets. It emphasizes that quality must be built into the product from the beginning, starting with validating the characteristics of the active pharmaceutical ingredients and excipients used. Analytical methods, manufacturing equipment, and the entire production process must also be validated to ensure reproducible quality batches. The validation program involves defining critical material attributes, establishing control parameters, and testing batches to set specification limits to maintain process control.
Qualification of tablet compression machinePritam Kolge
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
1) The document outlines the validation process for a tablet compression machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
2) The IQ establishes that the machine is installed correctly according to specifications. The OQ tests that the machine operates as intended at different speeds and settings.
3) The PQ evaluates the machine's compression capabilities by producing tablets and testing for characteristics like content uniformity, thickness, hardness, and friability. The validation protocol brings all stages together in a report.
This document discusses the qualification of manufacturing equipment. It explains that equipment qualification is necessary to ensure equipment works correctly and produces reliable results. There are four types of qualification: design, installation, operational, and performance. Design qualification defines equipment specifications. Installation qualification confirms proper installation. Operational qualification verifies equipment functions as specified. Performance qualification demonstrates consistent performance under routine use. The document then provides details on specific qualification procedures for dry powder mixers and fluidized bed dryers.
Process validation of tablet compressionSanket Shinde
This document provides an overview of tablet compression machine validation. It begins with introducing the need and types of process validation. Then it discusses validation of tablet compression machines in particular, including the critical parameters to monitor and qualify like compression force, speed, and in-process testing. It outlines the validation protocols for installation, operational, and performance qualifications. The document emphasizes the importance of revalidating if any changes are made to equipment, location, parts, or normal schedules.
The document summarizes the validation process for a tablet compression machine. It discusses the key stages of validation including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ involves verifying that the machine has been installed correctly according to specifications. The OQ tests the operation of the machine's controls and parameters. Finally, the PQ evaluates the machine's compression capabilities by testing the tablets' characteristics such as hardness, thickness, and friability. The document provides details about acceptance criteria for each validation stage.
The document discusses process validation for pharmaceutical manufacturing. It defines process validation and describes the objectives of validating manufacturing processes to consistently produce drugs that meet quality standards. The document outlines the types of process validation, including prospective, concurrent, retrospective, and revalidation. It also discusses selecting and evaluating industrial processes for tablet production, in-process testing, annual product reviews, and references.
This document summarizes the validation process for dry powder mixers used in pharmaceutical manufacturing. It discusses the need to validate mixers to ensure proper blending of active and inactive ingredients. The validation process includes installation qualification, operational qualification, and performance qualification to test the mixer under different conditions. Key parameters tested include content uniformity, bulk density, and sieve analysis of samples taken from different locations within the mixer. Advanced analytical tools can also be used to monitor blending in real time.
Support utilities validation.pptx (asmita magare)magareasmi
1) The document discusses the validation of various utilities used in pharmaceutical manufacturing including water systems, steam systems, compressed air systems, and HVAC systems.
2) Validation involves qualification phases including installation, operational, and performance qualifications to prove the design, procedures, and maintenance of the utilities under all expected operating conditions.
3) Key validation parameters discussed for each utility include particulate testing, pressure and airflow measurements, filter testing, and microbiological testing to ensure the utilities consistently meet quality standards.
This document discusses process validation for solid oral dosage forms. It defines process validation as establishing documented evidence through systematic approaches that give a high degree of assurance of consistency and quality characteristics. The key steps in developing a validation program are determining parameter limits using test data, challenging the process at these limits, and certifying equipment and tests. Critical process parameters for solid oral dosage forms include mixing/blending time and speed, granulation solvent addition rates, drying conditions, milling speeds, compression forces, and coating application rates. Process and equipment validation are necessary to conform to cGMP regulations and ensure uniform, reproducible quality products.
This document discusses granulation processes and quality management in the pharmaceutical industry. It covers topics like cGMP, SUPAC guidelines for post-approval changes, validation of granulation equipment and processes, and questionnaires for auditing granulation. The key points are that granulation is a critical manufacturing step that must be validated; SUPAC provides guidance on composition, batch size, site and equipment changes; and validation involves qualifying equipment and demonstrating consistent product quality through processes.
This document discusses statistical process control (SPC). It defines SPC and explains that its goal is to monitor processes and ensure they operate at their full potential to produce conforming products. There are two types of variation in processes: natural/common cause variation and special cause variation. The document then defines several key SPC terms and describes tools used in SPC like control charts. It provides examples of measuring equipment used for SPC and outlines the methodology for applying SPC to a CNC machine process.
This document discusses techniques for scaling up pilot plant operations in the pharmaceutical industry. It begins with definitions of key terms and explains the significance of pilot plants in permitting examination of formulas at an intermediate scale. The document outlines general considerations for pilot plant operations, including personnel requirements, equipment used, production rates, and process evaluation. It also covers master manufacturing procedures, product stability testing, and GMP compliance. Advantages are given as personnel can observe scale up runs and quality materials can be accessed, while disadvantages include reduced interaction between formulators and production staff.
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Process validation fof Pharmaceutical dosage forms (formulation)MD NOUSHAD JAVED
This document discusses process validation for solid dosage forms such as tablets. It defines process validation as establishing documented evidence through a systematic approach to give a high degree of assurance that a specific process consistently produces quality products meeting predetermined specifications. The document outlines key steps in validation including identifying, measuring, evaluating and documenting critical process parameters to ensure quality. It discusses validation of facilities, equipment, raw materials, analytical methods and monitoring of in-process and finished product tests to control critical process variables. The document provides guidelines for validating common unit operations in solid dosage manufacturing such as mixing, granulation, drying, milling, compression, coating and encapsulation.
Pilot plant scaleup techniques | unit 1 | Industrial pharmacyFirst name Last name
General considerations-including
significance of personnel requirements, space requirements, raw materials,Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation,
SUPAC guidelines,Introduction to platform technology
This document discusses the qualification of dissolution test apparatus and validation of utility systems. It covers the installation qualification, operational qualification, and performance qualification of dissolution test apparatus. This includes procedures, acceptance criteria, and maintenance schedules for qualifying the apparatus. It also summarizes validation test functions and acceptance criteria for key utility systems like plant steam, pure steam, water for injection, and emergency power generators. The goal is to ensure dissolution testing provides reliable and reproducible results for assessing drug release and bioavailability.
PILOT PLANT AND SCALE UP TECHNIQUES -1.pptxShubham ghodke
This document discusses techniques for scaling up plant and production processes in the pharmaceutical industry. It defines key terms like plant, pilot plant, and scale-up. The significance and general considerations of pilot plants are outlined. GMP, product, equipment, and personnel considerations for pilot plants are described. Specific processes for solid dosage forms like blending, granulation, drying, tablet coating, and capsule filling that must be addressed during scale-up are also summarized.
PILOT PLANT AND SCALE UP TECHNIQUES -.=.pptxShubham ghodke
The document discusses pilot plant and scale up techniques for pharmaceutical manufacturing. It defines a pilot plant as where a lab scale formula is transformed into a viable product through developing a practical manufacturing procedure. Scale up is the process of designing a prototype using data from the pilot plant. The document outlines general considerations for pilot plants including personnel requirements, equipment, production rates and GMP compliance. It also discusses advantages such as facilitating technology transfer and disadvantages like reduced direct interaction between formulators and production staff. Product considerations for solid dosage forms such as granulation, drying, tablet coating and capsule filling are also covered.
Similar to Validation of cone blender, mixer granulator and tablet compression machine. (20)
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.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
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
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
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.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Validation of cone blender, mixer granulator and tablet compression machine.
1. Validation of cone blender, mixer
granulator and tablet compression
machine
Presented by Ms. Mayuri Ghavate
(M.Pharm Pharmaceutics)
2. MAIN TOPICS
POINTS TO TALK ABOUT
To understand validation of equipments.
Validation of powder blenders mixers
granulators
tablet compression machine
3. Validation is the process of establishing documentary evidence
demonstrating that a procedure, process, or activity carried out in testing
and then production maintains the desired level of compliance at all
stage.
The validation concept was first proposed by the Food and Drug Administration
(FDA) in the mid-1970s to improve the quality of pharmaceutical products
4. EQUIPMENT VALIDATION
The process of equipment validation is based on the principle
that equipment must be designed, constructed, maintained, and
adapted to perform the operations which are to be carried out.
Equipment validation is Vital for-
• Safety.
• Fewer interruptions of work.
• Reduction of variation in results.
• Greater confidence in the reliability of results.
5. PHASESOF EQUIPMENT VALIDATION
1.Design Qualification
• User requirement specification
• Functional specification
• Operational specification
• Vendor specification
2. Installation Qualification
• Arrival Qualification
• Installation of hardware
and software
Pre- Validation Phase Process Validation
Phase
1.Operational Qualification
• Testing of Operational functions.
• Testing of Security function
2. Performance Qualification
• On-going performance testing
• Testing for specified applications
3. Revalidation
Validation
Maintenance Phase
routine servicing and
necessary repairs.
6. It is the responsibility of the production manager and technical services manager to follow
the procedure. The quality assurance manager is responsible for SOPcompliance.
PROCEDUREFORQUALIFICATION OFEQUIPMENT
7. Types of the powder blenders
1.V cone blenders
2. Double cone blenders
3. Drum mixer
4. Ribbon blenders
5. Conical screw mixer
6. Tumble blender
Validation of Blenders
8. CONE BLENDER
Cone Blender is an efficient and versatile machine for mixing of dry powders and granules
homogeneously. All the contact parts are made of stainless steel. The effective volume for
optimum homogeneity is between 35-70% of gross volume.
Why is the validation of Cone blender essential?
The mixing of the API and excipients is the critical step in the solid dosage form preparations that
affect the content uniformity at great extent.
9. URSfor the powder Blender
Operating criteria must be adequate
Spares should be available
Easy maintenance
Equipment should not disseminate dust
Low cost
Non reactive surface
Capacity
10. INSTALLATION QUALIFICATION
Details of the Equipment
Equipment name, made by & model No. Shall be noted down.
Location for the installation equipment shall be checked.
Utilities required shall be listed down.
Any deviation observed while following above procedure should be inform ed for corrective
action.
11. Operational qualification
After completions of successful installation qualification initiate the
actual operation of to ensure that machine is operating within
specification.
Check the operation qualification parameters against their
specifications.
Document the deviation details.
The Quality head and the department head shall decide whether
deviation is acceptable or not.
13. BLEND UNIFORMITY
This parameter is perhaps the most important to measure. It is not
easy, to define as it is both a physical (size, shape), and chemical
(composition) property.
14. Performance qualification
Load the materials to be mixed in the cone.
Start the mixer and rotate it for the time as mentioned in the BMR.
After completion of mixing switch OFF the mixer and separate out
the sample.
Collect the sample as per sampling procedure.
Send the samples to Quality control dept. for content uniformity,
bulk density and sieve analysis.
V cone blender Double cone blender
15. Latest advancements in the Blend analysis
1.NIR spectroscopy
2.Raman spectroscopy
3.Microscopic FTIR mapping
16. In evaluating a mixing process it is important to consider the worst case in all measurable parameters.
These include maximum and minimum mixer load, maximum and minimum speed (rpm), maximum and
minimum mixing time.
17. Revalidation Qualification:
Re-validation process is carried out in pharmaceutical industry at
periodic intervals and it is mandatory especially when the company
made any change in the formulas, procedures, manufacturing
systems, packaging, and support system such as electricity/ power
supply, water supply, and steam.
Revalidation criteria
Location of the equipment is changed.
There is change of spare/ parts that have a direct effect on
the performance of the equipment
At normal revalidation schedule.
18. Granulation, the process of particle
enlargement by agglomeration technique, is
one of the most significant unit operations in
the production of pharmaceutical dosage
forms, mostly tablets and capsules. Granulation
process transforms fine powders into free-
flowing, dust-free granules that are easy to
compress.
Granulation process can be divided into two
types: wet granulation that utilize a liquid in the
process and dry granulation that requires no
liquid
GRANULATORS:
19. Dry granulator
Roller Compactor:
are used to force fine powders between two counter rotating
rolls and presses the raw materials into a solid compact (flakes,
sheets, strips).
Polygran roller compactor
22. WET GRANULATOR
Wet granulation is a process that involves combining different
particles of powder together using liquid solutions and adhesives.
RAPID MIXERGRANULATOR -Homogenous mixing of dry & wet
powders, deaglomeration of wet mass and fast dispersion of
binding agent.
23. The installation must meet the manufacturer's specified
guidelines, along with design changes at installation. Also the
supporting electrical utilities must meet all electrical codes.
Equipment identification: Record the equipment identification
number, with equipment manufacturer, purchase order, model
number, and equipment number.
Required Documentation: The manufacturers operation and
maintenance manual and SOPs that coverthe set up.
Utility requirements Power, Water, Compressed air, spraying,
impeller movement, pneumatic discharge port.
Installation Qualification:
24. Operational Qualification:
Regulators, discharge port opening, spraying button.
Calibration requirements for temp, timer, pressure gauges,
ammeter.
Equipment control functions: Impeller, timer, bowl on/off &
slow/fast buttons.
Emergency, discharge port on/off Alarm, wash down walls
on/off.
26. TABLETCOMPRESSION MACHINE
A 45-STATION TABLETPRESSThe press is
automatic, high speed rotary press. A motor
drives the press at speeds that vary from 410
to 1630 tablets per minute (rpm). The
material being tableted is fed from a hopper
by gravity through the feed frame into dies.
Regulating the weight adjusting cam
controls the weight of material in each tablet
can be adjusted.
(Fluid pack Tablet compression Machine
Acura brand)
27. The supporting electrical utilities must meet all electrical codes.The
information required for an IQ evaluation is
equipment identification
required documentation
equipment utility requirements
major component specifications
component material, lubricants
equipment safety features.
INSTALLATION QUALIFICATION
28. competitive, w
s
Operational Qualification:
An OQ evaluation should establish that the equipment can operate
within specified tolerances and limits. The mechanical ranges of the tablet
press are challenged, along with the basic tablet press operations.
Information required for the OQ evaluation is:
calibration of the instruments used to control the tablet press
equipment control functions (switches and push buttons)
equipment operation ( c a m tracks, upper punches, lower punches, feed
frames, take off bars, rotor head direction, tablet press speed).
A) Cam Tracks Test
Install the punches and verify that the cams
are contacting the punch head angles on the
both the sides of the double-sided cams.
Verify that the punches are contacting one
side of the single-sided came through a full
cam track, upper and lower.
C) Lower Punch Test
A dial indicator test is required. Measure the
height of the lower punch above the die with
a dial indicator and record the results and
the instrument used to measure the height
B) Upper Punch Test
A verniercaliper is required for this test, which is
performed as follows: Attach a piece of tape to
mark the depth of penetration of an upper
punch when it is set to a standard depth.
Remove the upper punch and use a calibrated
vernier calliper to measure the depth of
penetration into the die. Record the results and
instrument used to measure the depth
D) Feed Frame Test
Feeler gauge test:
Measure the clearance
between the feed frame
and the motor head with
a feeler gauge and record
the results and the
instrument used to
measure the clearance.
E) Take Off Bar Test
The objective of the take-off
bar test is to verify that the
take-off bars do not make
contact with the lower
punches. Turn the tablet press
by hand and verify that the
takeoff bars do not make
contact with the lower
punches.
G) Tablet Press Speed
The objective of the speed
test is to verify that the
measured speeds are within ±
10%
of the manufacturer's
specification of a minimum of
9 rpm and a maximum of 36
rpm
30. Acceptance Criteria:
Average weight variation of the tablet should not be m ore than ± 2% of
target weight and individual weight variation should not be m ore than
±5% of target weight.
Hardness of the tablets should not be less than 2.0kg/cm2.
Friability should not be more than 1%.
Relative standard Deviation between the results of any test param eters
should not be more then 5%.
31. Subpart D – Equipment Section 211.67Equipment Cleaning
and Maintenance
Cleaning and maintenance activities are to prevent
malfunctions which could lead to contamination of a drug
product
Written procedures for cleaning and maintenance of
equipment should be established and followed
Records SHALLbe kept for cleaning, sanitizing,
maintenance and inspection
32. Increased throughput
Reduction in rejections and reworking
Reduction in utility costs
Avoidance of capital expenditures
Fewer complaints about process-related failures
Reduced testing in-process and in finished goods
More rapid and reliable start-up of new equipment
Easier scale-up from development work
Easier maintenance of equipment
Improved employee awareness of processes
More rapid automation
Application of Validation of equipments
33. Validation is an important process to ensure the safety,
reproducibility and purity of a substance.
Equipment Validation helps in obtaining reproducible results
as well as optimisation.
Equipment validation mainly operates in 4 parts DESIGN
VALIDATION, INSTALLATION VALIDATION, OPERATIONAL
VALIDATION and PERFORMANCE VALIDATION.
SUMMARY