IN PROCESS QUALITY CONTROL (IPQC) means controlling the procedures involved in manufacturing of the dosage forms starting from raw materials purchase to dispatch of the quality product in ideal packaging
This guidance provides recommendations for holders of animal drug applications on reporting categories for changes to conditions established in approved applications. It describes changes to manufacturing sites, scales, equipment, specifications, and processes for synthetic drug substances and intermediates. The guidance recommends reporting categories of annual reports, supplements for changes being effected in 30 days, or prior approval supplements based on the type and potential impact of changes.
The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document provides information about in-process quality control (IPQC) for a student named Pournima Ashok guided by Mrs. M. Harde. It defines IPQC as checks performed during production to monitor and adjust the process to ensure the product meets specifications. This may include controlling the environment or equipment. IPQC is intended to minimize errors, provide accurate procedures, detect errors, allow for corrective actions, identify responsibilities, and enforce established manufacturing and packing operations. Examples of IPQC for tablets include testing for container content uniformity, active ingredient content, tablet thickness, hardness, friability, and disintegration. Friability testing evaluates the tendency of tablets to fragment or powder during storage and handling.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
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 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.
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
This guidance provides recommendations for holders of animal drug applications on reporting categories for changes to conditions established in approved applications. It describes changes to manufacturing sites, scales, equipment, specifications, and processes for synthetic drug substances and intermediates. The guidance recommends reporting categories of annual reports, supplements for changes being effected in 30 days, or prior approval supplements based on the type and potential impact of changes.
The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document provides information about in-process quality control (IPQC) for a student named Pournima Ashok guided by Mrs. M. Harde. It defines IPQC as checks performed during production to monitor and adjust the process to ensure the product meets specifications. This may include controlling the environment or equipment. IPQC is intended to minimize errors, provide accurate procedures, detect errors, allow for corrective actions, identify responsibilities, and enforce established manufacturing and packing operations. Examples of IPQC for tablets include testing for container content uniformity, active ingredient content, tablet thickness, hardness, friability, and disintegration. Friability testing evaluates the tendency of tablets to fragment or powder during storage and handling.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
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 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.
This document provides guidelines for developing specifications for new drug substances and products according to ICH Q6A. It discusses universal and specific tests/criteria that should be included for drug substances and products, such as identification, description, assay, impurities, dissolution, disintegration, content uniformity, and microbial limits. The document gives acceptance criteria and justification for key tests like dissolution, discussing how to set Q values and limits based on biobatch results and BCS classification. It also provides guidance on other tests for oral liquids, parenterals and solid dosage forms.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document discusses out-of-trend (OOT) results, which occur when a result does not follow the expected trend based on past data. It notes that identifying OOT results is becoming a regulatory issue and introduces some statistical approaches for doing so, like using a minimum of 25 batches to set a trend range of average ±3 standard deviations. Some challenges of implementing OOT identification for commercial batches are determining the appropriate statistical approach, data requirements, and investigation process. The conclusion states that identifying OOT results is important for regulators and industry, and the method should not be too complex.
This document discusses auditing of vendors that supply capsules and sterile products to pharmaceutical companies. It describes the benefits of conducting vendor audits such as cost savings, process improvements, and risk reduction. The document outlines the vendor selection process and procedures for auditing vendors. Key areas examined in a vendor audit include facilities, personnel, validation, documentation, and finished product quality controls. Manufacturing processes for capsules and sterile products are also summarized. The checklist covers auditing of vendors' premises, equipment, documentation, samples, and compliance with regulations.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
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.
Purchase specifications & Maintenance of stores For Raw materialsYash Menghani
This document discusses the purchase specifications and maintenance of stores for raw materials. It defines raw materials as all materials used in manufacturing finished products. Purchase specifications provide guidelines that define operational, physical and chemical characteristics and quality of items to be acquired. Maintaining proper stores is important, requiring inspection centers, storage at appropriate temperatures, and clear labeling of materials with names, batch numbers, and expiration/retesting dates.
Process validation establishes documented evidence that a manufacturing process will consistently produce products meeting specifications. It involves qualifying facilities and equipment, validating critical process parameters, and revalidating when changes occur. Validation includes prospective validation of new processes and retrospective validation of existing stable processes by statistical analysis of historical batch data. Documentation of the validation master plan, protocols, reports, and results provide assurance that processes are properly controlled.
The document discusses procedures for handling deviations and market complaints. It defines deviations as unexpected events that occur during operations, documentation, or testing. Deviations are categorized as critical, major, or minor depending on their potential impact. All deviations must be documented, investigated, and tracked. Market complaints regarding product quality must also be investigated. A cross-functional team investigates critical or major issues to identify root causes and preventive actions. Trend analysis of deviations is performed annually to monitor quality. Proper documentation and handling of deviations and complaints is required.
The document is a presentation on post-approval changes to bulk active chemicals. It discusses FDA guidance called BACPAC (Bulk Active Chemicals & Post Approval Changes) which provides recommendations for post-approval changes to drug substance synthesis, including site, scale and equipment changes as well as specification and manufacturing process changes. The guidance covers assessing equivalence after changes and determining the appropriate reporting category based on the potential effects of changes.
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.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
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.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document discusses in-process quality control (IPQC) tests for parenteral products. It describes several key IPQC tests including drug content assays, clarity testing to detect particulate matter using various methods, leakage testing of ampoules using dye bath or spark tests, sterility testing using membrane filtration or direct inoculation methods, and endotoxin/pyrogen testing. Maintaining strict quality controls during manufacturing is important for ensuring parenterals are sterile, pyrogen-free, and free of particulate matter when injected into the body.
Leakage tests are used to test package integrity and detect leaks that could allow contamination. There are four main types of leakage tests: visual inspection, bubble test, dye test, and vacuum ionization test. Visual inspection is the simplest but least sensitive method, while dye test is widely used in industry. Clarity and particulate contamination tests are also important to ensure parenteral products are free of visible particles and meet sub-visible particle limits. The light obscuration and microscopic particle count tests are commonly used to detect sub-visible particles.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document discusses out-of-trend (OOT) results, which occur when a result does not follow the expected trend based on past data. It notes that identifying OOT results is becoming a regulatory issue and introduces some statistical approaches for doing so, like using a minimum of 25 batches to set a trend range of average ±3 standard deviations. Some challenges of implementing OOT identification for commercial batches are determining the appropriate statistical approach, data requirements, and investigation process. The conclusion states that identifying OOT results is important for regulators and industry, and the method should not be too complex.
This document discusses auditing of vendors that supply capsules and sterile products to pharmaceutical companies. It describes the benefits of conducting vendor audits such as cost savings, process improvements, and risk reduction. The document outlines the vendor selection process and procedures for auditing vendors. Key areas examined in a vendor audit include facilities, personnel, validation, documentation, and finished product quality controls. Manufacturing processes for capsules and sterile products are also summarized. The checklist covers auditing of vendors' premises, equipment, documentation, samples, and compliance with regulations.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
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.
Purchase specifications & Maintenance of stores For Raw materialsYash Menghani
This document discusses the purchase specifications and maintenance of stores for raw materials. It defines raw materials as all materials used in manufacturing finished products. Purchase specifications provide guidelines that define operational, physical and chemical characteristics and quality of items to be acquired. Maintaining proper stores is important, requiring inspection centers, storage at appropriate temperatures, and clear labeling of materials with names, batch numbers, and expiration/retesting dates.
Process validation establishes documented evidence that a manufacturing process will consistently produce products meeting specifications. It involves qualifying facilities and equipment, validating critical process parameters, and revalidating when changes occur. Validation includes prospective validation of new processes and retrospective validation of existing stable processes by statistical analysis of historical batch data. Documentation of the validation master plan, protocols, reports, and results provide assurance that processes are properly controlled.
The document discusses procedures for handling deviations and market complaints. It defines deviations as unexpected events that occur during operations, documentation, or testing. Deviations are categorized as critical, major, or minor depending on their potential impact. All deviations must be documented, investigated, and tracked. Market complaints regarding product quality must also be investigated. A cross-functional team investigates critical or major issues to identify root causes and preventive actions. Trend analysis of deviations is performed annually to monitor quality. Proper documentation and handling of deviations and complaints is required.
The document is a presentation on post-approval changes to bulk active chemicals. It discusses FDA guidance called BACPAC (Bulk Active Chemicals & Post Approval Changes) which provides recommendations for post-approval changes to drug substance synthesis, including site, scale and equipment changes as well as specification and manufacturing process changes. The guidance covers assessing equivalence after changes and determining the appropriate reporting category based on the potential effects of changes.
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.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
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.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document discusses in-process quality control (IPQC) tests for parenteral products. It describes several key IPQC tests including drug content assays, clarity testing to detect particulate matter using various methods, leakage testing of ampoules using dye bath or spark tests, sterility testing using membrane filtration or direct inoculation methods, and endotoxin/pyrogen testing. Maintaining strict quality controls during manufacturing is important for ensuring parenterals are sterile, pyrogen-free, and free of particulate matter when injected into the body.
Leakage tests are used to test package integrity and detect leaks that could allow contamination. There are four main types of leakage tests: visual inspection, bubble test, dye test, and vacuum ionization test. Visual inspection is the simplest but least sensitive method, while dye test is widely used in industry. Clarity and particulate contamination tests are also important to ensure parenteral products are free of visible particles and meet sub-visible particle limits. The light obscuration and microscopic particle count tests are commonly used to detect sub-visible particles.
This document discusses quality control testing for parenteral products. It describes 8 types of tests: 1) clarity testing to check for particulate matter, 2) leakers testing to check package integrity, 3) fill volume testing, 4) pH testing, 5) pyrogen testing which can be done with the rabbit fever response test or LAL test, 6) assay for drug content, 7) sterility testing, and 8) testing of packing containers for glass and plastic. It provides details on procedures for particulate matter testing using visual, light obscuration, and membrane microscopy methods and discusses leaker testing methods like visual inspection, bubble testing, dye testing, and vacuum ionization testing.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
The document discusses in-process quality control (IPQC) tests for injections. It defines injections and describes the purpose of IPQC in ensuring quality from raw materials to finished product. The document outlines various IPQC tests conducted, including environmental monitoring, pH measurements, viscosity testing, osmolality testing, conductivity measurements, temperature monitoring during heat sterilization, volume filled checks, leakage testing, clarity testing, pyrogen testing, and sterility testing. Specific methods for many of the tests are described in detail.
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
IPQC FOR PARENTRALS AND OPTHALMIC PRODUCTSSaiBapat
The document discusses in-process quality control (IPQC) for parenteral and ophthalmic products. It describes the importance of IPQC in minimizing errors and ensuring quality. Key IPQC tests for parenterals and ophthalmics include leakage testing, sterility testing, pyrogen testing, clarity testing, and testing for content uniformity and weight. Specific methods are provided for each test, such as membrane filtration for sterility testing and the LAL test for pyrogen detection. Acceptance criteria are also outlined.
In process and finished products quality control forVidyaNani
In-process quality control (IPQC) and finished product quality control (FPQC) tests are important for ensuring the quality of parenteral and ophthalmic products. Key IPQC tests include leakage testing using dye bath tests and clarity testing to check for particulate matter. Key FPQC tests include sterility testing using membrane filtration or direct inoculation methods, pyrogen testing using the Limulus Amoebocyte Lysate test, and content uniformity and weight checks. For ophthalmics, important tests include sterility testing, clarity testing, leakage testing of tubes, and checking for metal particles. Regulatory pharmacopoeias provide specifications for limits according to the intended market.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
This document summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
This document discusses sterility testing methods according to various pharmacopoeias. It provides details on membrane filtration and direct inoculation methods for testing sterility of pharmaceutical products like injections and ophthalmic preparations. These methods are based on incubating the product samples in fluid thioglycollate medium and soybean-casein digest medium to check for microbial growth. Validation of sterility testing methods and interpretation of results are also covered.
Sterility test and modern microbiological methodsMohammed Fawzy
This document provides an overview of sterility testing and rapid microbiological methods. It discusses sterility testing, including definitions, common media used, methods for preparing different types of test products, incubation periods, growth promotion tests, and interpreting results. It also briefly introduces some rapid microbiological methods like ATP bioluminescence, colorimetric growth detection, and cytometry systems. The key purpose of sterility testing is to detect any viable microorganisms in pharmaceutical products or medical devices labeled as sterile.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the quality control tests of parenteral as referred in the pharmacopoeia.
Thank you for reading. Hope it was of help to you.
UIPS,PU team
This document discusses various methods for assessing the efficacy of disinfectants and sterilization processes, including physical, chemical, and biological indicators. The turbidimetric method uses turbidity measurements after a short incubation period to assess the ability of disinfectants and antibiotics to inhibit bacterial growth. Chemical indicators monitor sterilization processes by undergoing color changes in response to heat, steam, or radiation. Biological indicators use bacterial spores to validate the sterilization of equipment and facilities.
Preparation of large volume and small volume parenteralsangram maskar
Large volume parenterals are sterile aqueous drug products packaged in single-dose containers holding 100 mL or more. Small volume parenterals are packaged in containers holding 100 mL or less. Both are administered via intravenous, intramuscular, or subcutaneous routes. Key differences include that small volume parenterals may use preservatives and not require isotonicity, while large volume parenterals must be isotonic. Both undergo processes like cleaning, preparation, sterilization, filling, and packaging to ensure sterility. They are tested using methods like sterility testing, particulate testing, and pyrogen testing to ensure quality and safety.
This document discusses sterility testing procedures as per the Indian Pharmacopoeia. It describes that sterility testing is done on pharmaceutical products required to be sterile. The test is performed under aseptic conditions using appropriate culture media like fluid thioglycollate medium or soybean-casein digest media. The document outlines the membrane filtration and direct inoculation methods for sterility testing and provides details on procedures, quantities of sample used, incubation periods, and interpretation of results. A product passes sterility testing if no microbial growth is observed in the culture media after 14 days of incubation.
The document discusses quality control tests for parenterals. Parenterals are sterile products intended for injection or implantation into the body. They require higher care in preparation than oral or topical products and must be sterile, non-pyrogenic, and free of particles. Key quality control tests include: 1) content uniformity testing to ensure consistent active ingredient amounts, 2) package integrity testing to check for leaks, 3) clarity testing to detect particles, 4) pyrogen testing using the Limulus amebocyte lysate assay to detect endotoxins, and 5) sterility testing using membrane filtration or direct inoculation methods. These tests ensure parenterals meet strict quality standards for safety.
Defination,test method, steps, principle, designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
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Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Physiology and chemistry of skin and pigmentation, hairs, scalp, lips and nail, Cleansing cream, Lotions, Face powders, Face packs, Lipsticks, Bath products, soaps and baby product,
Preparation and standardization of the following : Tonic, Bleaches, Dentifrices and Mouth washes & Tooth Pastes, Cosmetics for Nails.
1. IPQC FOR PARENTERALS
Prepared by:
Mr. Petkar Kaleem Mazhar (Roll no: 27)
Ms. Patil Komal Dagadu (Roll no: 26)
M. Pharm – Quality Assurance.
2. PURPOSE OF IPQC:
To ensure detectable and significant human errors.
Equipment failure and idiosyncrasies.
Abnormal interpretation.
Adoption of given procedures.
IN PROCESS QUALITY CONTROL:
IPQC means controlling the procedures involved in manufacturing
of the dosage forms starting from raw materials purchase to
dispatch of the quality product in ideal packaging.
It monitors all the features of the product that may effect its quality
and prevents errors during processing.
It is the activity performed between QA and QC.
3. PARENTERALS
A parenteral dosage form can be defined as a sterile drug product
which is presented in the form of solutions, suspension, emulsion,
or reconstituted lyophilized powder, suitable for administration by
injection through skin or mucous membrane.
What are parenterals?
Greek para= “Beside” and enteron= “Intestine”, because it
bypasses the intestines.
.
4. FLOW CHART OF PARENTERALS FROM PRODUCTION
TO MARKET.
MANUFACTURING OF PRODUCTS.
STERILIZATION OF PRODUCTS.
ASEPTIC SUB-DIVISON AND SEALING.
ONLINE TESTING.
CAPPING / OUTER SEALING.
INSPECTION
QUARANTINE.
FINISHING LABELING AND PACKAGING.
WAREHOUSE
MARKET.
5. Types of parenterals
1. Small volume parenterals (SVPs): They are given as multiple
dose.
Small volume parenterals contains-
a. Ampoules,
b. Vials.
C. Dry powders.
a. Ampoules b. Vials c. Dry
powders
6. 2. Large volume parenterals (LVPs): They are designed to provide
fluid, calories and electrolytes. They are of 4 types.
a. Hyperalimentation solution.
b. Cardioplegic solution.
c. Peritoneal dialysis solution.
d. Irrigating solution.
9. IPQC FOR PARENTERAL PRODUCTS
Pyrogen testing.
➡Rabbit fever response test.
➡Limulus amoebocycte lysate test.
Sterility test.
➡Membrane filtration method.
➡Direct inoculation method.
Test for packaging containers.
1. For glass containers:
➡Water attack test.
➡Powder glass test.
2. For plastic containers:
➡Leakage test, collapsibility test, transparency test and
water vapor permeability test.
Assay for drug content.
10. CLARITY TEST
Visual method:
A. In visual inspection, each injectable is
inspected visually against white and black
backgrounds. The white background aids in
detection of dark colour particles.
B. The light or reflective particles will appear
against the black back ground.
C. A magnifying lens at 2.5 × magnification set
at the eye level facilitates the inspection.
Microscopic examination enhances detection
of particulate matter in injectable.
D. Acceptance Standards is that each container
checked must not contain any visible
particulate matter.
11. CLARITY TEST
Coulter counter counts the particles in a sample based on the
change in the electrical resistance. Particle size detection limit in
this instrument is from 0.1 to 1000 micrometer.
The powder sample requires pretreatment such as dispersion in
an electrolyte to form a very dilute suspension.
The suspension is usually subjected to ultrasonic agitation to
avoid particle agglomerates.
A dispersant may also be added to aid particle deagglomeration.
Particles below 0.2μm can also be detected.
This test is not recommended by FDA for parenteral.
Coulter counter method.
12. xdzdzd
Limits for detection of subvisible particulate matter as prescribed in USP.
Particle size SVP LVP
Less than equal to 10μm 3000/Container 12/ml
Less than equal to 25μm 300/Container 2/ml
13. Light obscuration method
Tungsten lamp produces a constant collimated beam of light that
pass through a small rectangular passageway and impinges onto a
photodiode.
Liquid can flow through the passageway between the light source
and photodiode.
If a single particle transverses the light beam there results a
reduction in normal amount of light received by the photodiode.
This reduction of light and the measurable decrease in the output
from the photodiode is proportional to the area of the particle
interrupting the light flow.
Thus light obscuration principle measures particle size based
diameter of circle having equivalent area.
14. Leakage test
Used to test package integrity.
Leakage test is employed to detect incompletely sealed
ampoule and vials so that they may be discarded.
WHAT IS THE NEED?
➡Presence of capillary pores or tiny cracks can cause
microbes or other contaminants to ender in the ampoules.
➡Change in temp during storage can cause expansion and
contraction of the ampoule and thereby causing interchange
of its contents if any opening exists.
➡Leakage test is done by visual inspection, bubble test and
dye bath test.
15. LEAKAGE TEST
A. DYE BATH:
The test container is immersed in a dye bath. Vacuum and
pressure is applied for some time.
The container is removed from the dye bath and washed. The
container is then inspected for the presence of dye either visually
or by means of UV spectroscopy.
The dye used may be of blue, green, yellowish-green color.
The dye test can be optimized by use of a surfactant and or a low
viscosity fluid in the dye solution to increase the capillary
migration through the pores.
The dye test is widely accepted in industry and is approved in drug
use. The test is inexpensive and is requires no special equipment
required for visual dye detection.
However, the test is qualitative, destructive and slow. The test is
used for ampoules and vials.
16. Leakage test
B. VISUAL INSPECTION:
Visual method is the easiest leak test method to perform. But this
method is least sensitive.
The method is used for the evaluation of large volume parenteral.
To increase the sensitivity of the method, the visual inspection of
the sample container may be coupled with the application of
vacuum to make leakage more readily observable.
This method is simple and inexpensive. However, the method is
insensitive, operator dependent, and qualitative.
Sometimes, the method is used in combination with pressure and
/or temperature cycling to accelerate leakage to improve
sensitivity.
17. C. BUBBLE TEST:
The test package is submerged in liquids. A differential pressure is
applied on the container. The container is observed for bubbles.
Sometimes, surfactant added liquid is used for immersion of test
package. Any leakage is evident after the application of differential
pressure as the generation of foaming in immersion liquid. The method
is simple and inexpensive.
The location of the leaks can be observed in this method. However, it is
relatively insensitive and the findings are operator dependent and are
qualitative.
The optimized conditions can be achieved using a surfactant immersion
fluid along with the dark background and High intensity lighting.
Generation of a differential positive pressure of 3 psi inside the vial and
observation of any leakage using magnifying glass within a maximum test
time of 15 minutes. Positive leak test result. Air bubbles
Leakage test
18. pH
Checking the bulk solution, before
filling for drug content, PH< color,
clarity and completeness of solution.
The pH of a formulation must be
considered from following
standpoints:
1. The effect on the body when the
solution is administered.
2. The effect on stability of the product.
3. The effect on container-closure system.
pH measurement:
1. pH is measured by using a pH meter.
2. pH meter is initially calibrated with
respective buffer capsule then the pH of
the preparation is measured.
19. STERILITY TEST
A. MEMBRANE FILTRATION METHOD:
Sterilization of filtration system and membrane filtration of
examined solution under aseptic conditions.
Filtration of the sample through a membrane filter having the
nominal size of 0.45µ and a diameter of 47mm.
After filtration the membrane is removed aseptically from the
metallic holder and divided into two halves.
The first half is transferred into 100 ml of culture media meant
for fungi and incubated at 20˚ to 25 ˚c for not less than seven
days.
The other half is transferred into 100ml of fluid thioglycolate
medium and incubated at 30 to 35 ˚c for not less than 7 days.
20. STERILITY TEST
➡DISADVANTAGES:
1. This method cannot differentiate
the extent of contamination between
units if present because all product
contents are combined and filtered
through a single filter and cultured in
single test tube.
2. There exists a higher probability of
inadvertent contamination in
manual operations .
21. B. Direct inoculation method:
Required quantities of liquid is
removed from the test containers
with a sterile pipette / sterile syringe.
Aseptically transfer the specified
volume of the material from each
container to vessel of culture medium
Mix the liquid with medium but
not aerate excessively
22. ➼Fluid thioglycolate medium(FTM):
FTM provides both aerobic and anaerobic environments
within the same medium. FTM is an excellent medium for
the detection of bacterial contamination.
Thioglycolate has the advantage of neutralizing the
bacteriostatic properties of mercurial preservatives
incubation of the media: 14 days at 30 -35°C
➼Soybean casein digest medium:
Soybean casein digest medium primarily intended for the
culture of both fungi and aerobic bacteria specific role of
some ingredients. incubation of the media: 14 days at 20 -
25°C
TYPES OF MEDIUM USED:
23. Pyrogen test
A. RABBIT FEVER RESPONSE TEST:
➡ Principle: The test involves measurement of rise in body temperature of
the rabbits following the intravenous injection of a sterile solution of the
substance to be tested. The body temperature of the rabbits increases if
pyrogens are present in the injected test solution.
➡Procedure: Preparation of the sample:
I. Warm the solution to About 37 ± 2 o c before the injection
II. In the case of lyophilized products dissolve it in normal saline solution.
24. ➡ Determination of initial temperature of rabbits:
I. Insert a clinical thermometer into the rectum of each rabbit
and normal readings of body temperature are taken prior to
the injection of test solution.
II. Two such readings are taken at an interval of 30 minutes
and the mean is calculated.
III. This mean reading is taken as the initial temperature of the
rabbits or as a control.
25. ➡Determination of the response of rabbits:
I. The test solution is injected into the ear vein of each rabbit.
II. The volume of injection is 10 ml/kg of the body weight.
III. This volume varies according to the test substance and is
prescribed in the individual monograph.
IV. Record the temperature of each rabbit at an interval of 30
minutes for 3 hours after the injection.
V. This is the maximum temperature recorded for that rabbit.
VI. The difference between maximum temperature and initial
temperature is taken as its response.
VII. If this difference is negative, it is taken as a zero response.
26.
27. ➡INTERPRETATION OF THE RESULTS:
The test is carried out on the first group of 3 rabbits; if necessary
on further groups of 3 rabbits to a total of 4 groups, depending on
the results obtained
Intervals of passing or failing of products are on the basis of
summed temperature response.
➡ The Result of pyrogen test:
If above tests not passes the sample is said to pyrogenic.
No, of rabbits Individual Temp,
Rise (°C )
Temp. rise in group
(°C )
Test
3 Rabbits 0.6 1.4 Passes
If above not passes
3+5=8 rabbits
0.6 3.7 Passes.
28. Limulus Amebocyte Lysate Test (LAL Test)
PRINCIPLE:
The addition of solution containing endotoxin to a solution of lysate produce
turbidity . The rate of reaction depends upon concentration of endotoxin , the pH and
the temperature.
The endotoxin reference standard is the freeze dried. The test is based on the
primitive blood- clotting mechanism of the horseshoe crab.
LAL Test is done by 3 methods:
1. Gel clot technique 2. Kinetic Turbidimetric 3. Chromagenic technique
29. If the solid remains intact the product is
considered to contain endotoxin.
I. Gel clot bacterial endotoxin
First of all, we have to prepare test
tubes of 4 samples dilutions.
Then LAL reagent is added to the
equal volume of the test tubes.
After that the test tubes are agitated and
then allowed to incubate for 1 hr at 37 C.
After incubation the tubes are
inverted
30. 2. Kinetic turbidimetric technique.
The sample is taken
LAL reagent is added to the
sample.
Produce gel-clot
This result in turbidity
It is a photometric assay
measuring the increase in
turbidity caused by the
reaction of endotoxin and
the lysate.
A spectrophotometer is
used in this regard.
In this method turbidity is
developed after cleavage of
an endogenous substrate.
31. 3. Chromogenic method
The chromogenic method is also
photometric assay measuring the
colour, developed by the
chromophore and released by the
chromogenic substrate by the
reaction with endotoxin lysate.
The resulting colour of the reaction is
measured using spectrophotometric
method to reveal the concentration of
the endotoxin in the sample.
The chromogenic reagent used in this
method is a peptide connected to p-
nitroaniline, a yellow clottable
coagulant.
Procedure:
First of all, the LAL reagent is
mixed with all chromogenic
reagent.
The mixture is then
added to the test sample
to create the test
solution.
The test solution is
then allowed to
incubate.
If endotoxin is
present, the
enzymatic rxn of the
LAL reagent break
the peptide bond
and releases yellow
colour
32. TEST FOR PACKAGING CONTAINERS
I. For glass containers:
a. Water attack test:
I. Rinse 3 or more containers with high purity water. Fill each
container to 90% of its capacity with high purity water.
II. Cap all the flasks with borosilicate glass beaker, place in the
autoclave at 121 C for 60 min
III. cool the flask, decant the water from the flask into a clean vessel
IV. add 5 drops methyl red solution, titrate immediately with 0.02 N
sulfuric acid .
V. Record the volume of 0.02N Sulfuric acid used to neutralize the
extract from 10 g of the prepared specimen of glass
33. b. Powder Glass test:
I. Use crushed glass containers in 250-ml conical flask, add 50 ml
high purity water, cap the flask with borosilicate glass beaker
II. Place the containers in the autoclave and close it securely hold
temperature at 1210c±2 0c for 30 min., counting from the time
this temperature is reached.
III. cool the flask, decant the water from the flask into a clean
vessel, and wash the residual powdered glass with high purity
water, add 5 drops methyl red solution, titrate immediately
with 0.02 N sulfuric acid .
IV. Record the volume of 0.02N Sulfuric acid used to neutralize
the extract from 10 g of the prepared specimen of glass.
34. II. For plastic containers:
a. Collapsibility test:
Container is checked weather it has enough durability to
hold the drug and does not collapse or break open.
b. Transparency test:
Fill five empty containers to their nominal capacity with
diluted suspension as described in IP 1966. The cloudiness
of the diluted suspension in each container is detectable
when viewed through the containers as compared with a
container of the same type filled with water.
35. C. Water vapor permeability test:
i. Fill five containers with nominal volume of water and
heat seal the bottles with an aluminium foil-poly ethylene
laminate or other suitable seal.
ii. Weigh accurately each container and allow to stand
(without any overwrap) for 14 days at a relative humidity of
60+5% and a temperature between 20 and 25 °C
iii. Reweigh the containers. The loss in weight in each
container is not more than 0.2%.
36. Assay for drug content.
Assay is performed according to method given In the
monograph of that parental preparation in the
pharmacopeia.
Assay is done to check the quantity of medicament present
in the parenteral preparation.
So we can know the exact amount of medicament present
such that it can perform its action.
We should follow the official monograph IP/BP/USP for
performing the assay.