This document discusses quality control in the pharmaceutical industry. It defines quality control and explains that it is essential to ensure pharmaceutical products are safe, pure, and effective. It describes various in-process quality control tests done at different stages of production for tablets, capsules, syrups, semisolids, and injectables. These tests evaluate attributes like drug content, hardness, dissolution, and sterility. Finally, it compares quality control tests for tablets specified in British, Indian, and US pharmacopeias.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
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.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
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.
Impurities in Drug Substance & in Drug ProductKamal Ambalia
The document provides guidance on impurities in drug substances and products. It discusses the classification of impurities into organic, inorganic, and residual solvents. It describes the rationale for reporting and controlling impurities and outlines identification thresholds, reporting thresholds, and qualification thresholds based on maximum daily dose. Analytical procedures for impurity detection and identification must be validated. Impurities above thresholds require identification and qualification. The new drug specification must include impurities above reporting thresholds. Residual solvent limits are based on ICH Q3C guidelines.
This document provides qualification procedures for an electronic balance, pH meter, and UV-visible spectrophotometer. It describes design qualification, installation qualification, and operational qualification tests. For the electronic balance, design qualification includes supplier certification. Installation qualification includes installation and operational tests using reference weights. Operational qualification includes daily measurement of reference weights. For the pH meter and spectrophotometer, design qualification includes selection criteria. Installation qualification includes installation and checks. Operational qualification includes calibration and performance verification tests using standards traceable to national references.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
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.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
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.
Impurities in Drug Substance & in Drug ProductKamal Ambalia
The document provides guidance on impurities in drug substances and products. It discusses the classification of impurities into organic, inorganic, and residual solvents. It describes the rationale for reporting and controlling impurities and outlines identification thresholds, reporting thresholds, and qualification thresholds based on maximum daily dose. Analytical procedures for impurity detection and identification must be validated. Impurities above thresholds require identification and qualification. The new drug specification must include impurities above reporting thresholds. Residual solvent limits are based on ICH Q3C guidelines.
This document provides qualification procedures for an electronic balance, pH meter, and UV-visible spectrophotometer. It describes design qualification, installation qualification, and operational qualification tests. For the electronic balance, design qualification includes supplier certification. Installation qualification includes installation and operational tests using reference weights. Operational qualification includes daily measurement of reference weights. For the pH meter and spectrophotometer, design qualification includes selection criteria. Installation qualification includes installation and checks. Operational qualification includes calibration and performance verification tests using standards traceable to national references.
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
The document discusses validation of critical utility systems used in pharmaceutical manufacturing facilities. It focuses on validation of HVAC, water, and steam systems. For HVAC validation, it provides details on DQ, IQ, OQ, and PQ protocols including objectives, responsibilities, tests performed. It discusses user requirements, specifications for HVAC control and monitoring. For water system validation, it discusses purification methods, grade of water, and protocols for IQ, OQ and PQ. It also discusses two types of steam systems - house steam and clean steam - and validation considerations for each.
This document discusses cleaning validation, which provides documented evidence that approved cleaning procedures will produce equipment suitable for processing pharmaceutical products. It defines different levels of cleaning validation based on risk. Key aspects covered include cleaning techniques, establishing acceptance criteria, sampling methods, analytical methods, and documentation requirements. The goal of cleaning validation is to achieve an appropriate level of cleanliness to avoid contamination between product batches.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
This document describes the bioassay of heparin sodium. It introduces heparin as an anticoagulant glycosaminoglycan used medically. The bioassay principle involves comparing the concentration of a test heparin solution to a standard solution needed to prevent clotting in plasma. The method prepares plasma by centrifuging citrated blood and adding calcium chloride. Known concentrations of a standard heparin and the test solution are added to plasma samples. Clotting is observed after one hour and the potency of the test solution is estimated by comparing its clotting effect to the standard. The results may require repeating the assay with new dilutions of the test solution if no correspondance is found.
IPQC checks are carried out during the manufacturing process to monitor critical variables that can impact product quality. In-process materials are tested for identity, strength, and purity, and any rejected materials are quarantined. The objectives are quality control, process control, and ensuring final product quality through continuous monitoring and implementation of good manufacturing practices. IPQC involves establishing and documenting controls to ensure output falls within acceptable standard ranges.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
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.
stability testing of phytopharmaceuticals.pdfKGNithyaLakshmi
Stability testing is necessary to ensure the product is of acceptablequality throughout its entire storage period.
An important part of quality control of herbal products is theevaluation of the chemical stability of a finished product during thestorage period.
Stability testing of herbal products is a challenging task because theentire herb or herbal product is regarded as the active substance,regardless of whether constituents with defined therapeutic activityare known.With the help of modern analytical techniques like HPLC,HPTLC and by employing proper guidelines it is possible toestablish sound stability data for herbal products and predicttheir shelf life which will help in global acceptabilityof herbalproducts.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
This document provides information on the preparation and potency determination of oxytocin and human antihaemophilic vaccine. It describes that oxytocin is obtained from pituitary glands and stimulates uterine contraction and milk ejection. Its potency is determined by comparing its activity to a standard preparation in assays measuring blood pressure depression in chickens. The document also describes that human antihaemophilic vaccine is prepared from human plasma to be rich in clotting factor VIII. Its potency is determined by comparing the amount needed to reduce clotting time to that of a standard preparation in an assay using citrated plasma.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses pharmaceutical validation including definitions of qualification and validation. It provides details on types of qualification including design, installation, operational and performance qualification. Validation types such as prospective, concurrent and retrospective validation are summarized. The importance of validation master plan and validation protocols are highlighted. Key aspects of streamlining validation operations are also covered such as the importance of parallel development of API, analytical methods and drug product.
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
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.
In process & finished products quality control test for pharmaceuticalsSuraj Ghorpade
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for pharmaceutical products. It defines IPQC and outlines its objectives to optimize processes, monitor operations, and inspect raw materials, equipment, environment and more. Key IPQC tests are described including physical/chemical tests (identity, quality, purity, potency), biological/microbiological tests. Specific IPQC parameters and checks are provided for tablets, including tests for size/shape, color, thickness, assay, dissolution and more. Acceptance criteria are defined according to pharmacopeial standards. The importance of IPQC for ensuring quality products is emphasized.
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
The document discusses validation of critical utility systems used in pharmaceutical manufacturing facilities. It focuses on validation of HVAC, water, and steam systems. For HVAC validation, it provides details on DQ, IQ, OQ, and PQ protocols including objectives, responsibilities, tests performed. It discusses user requirements, specifications for HVAC control and monitoring. For water system validation, it discusses purification methods, grade of water, and protocols for IQ, OQ and PQ. It also discusses two types of steam systems - house steam and clean steam - and validation considerations for each.
This document discusses cleaning validation, which provides documented evidence that approved cleaning procedures will produce equipment suitable for processing pharmaceutical products. It defines different levels of cleaning validation based on risk. Key aspects covered include cleaning techniques, establishing acceptance criteria, sampling methods, analytical methods, and documentation requirements. The goal of cleaning validation is to achieve an appropriate level of cleanliness to avoid contamination between product batches.
This document provides information on various qualification documents used in pharmaceutical industries, including:
- User Requirement Specification (URS) which documents the end user requirements and functionality.
- Design Qualification (DQ) which verifies that the design will meet the requirements in the URS.
- Installation Qualification (IQ) which verifies proper installation.
- Operational Qualification (OQ) which tests the operation of the equipment.
- Performance Qualification (PQ) which verifies the equipment can perform as intended based on approved processes and specifications.
Guidance and requirements for each qualification type are defined. Supporting documents required for each are also listed.
This document describes the bioassay of heparin sodium. It introduces heparin as an anticoagulant glycosaminoglycan used medically. The bioassay principle involves comparing the concentration of a test heparin solution to a standard solution needed to prevent clotting in plasma. The method prepares plasma by centrifuging citrated blood and adding calcium chloride. Known concentrations of a standard heparin and the test solution are added to plasma samples. Clotting is observed after one hour and the potency of the test solution is estimated by comparing its clotting effect to the standard. The results may require repeating the assay with new dilutions of the test solution if no correspondance is found.
IPQC checks are carried out during the manufacturing process to monitor critical variables that can impact product quality. In-process materials are tested for identity, strength, and purity, and any rejected materials are quarantined. The objectives are quality control, process control, and ensuring final product quality through continuous monitoring and implementation of good manufacturing practices. IPQC involves establishing and documenting controls to ensure output falls within acceptable standard ranges.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
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.
stability testing of phytopharmaceuticals.pdfKGNithyaLakshmi
Stability testing is necessary to ensure the product is of acceptablequality throughout its entire storage period.
An important part of quality control of herbal products is theevaluation of the chemical stability of a finished product during thestorage period.
Stability testing of herbal products is a challenging task because theentire herb or herbal product is regarded as the active substance,regardless of whether constituents with defined therapeutic activityare known.With the help of modern analytical techniques like HPLC,HPTLC and by employing proper guidelines it is possible toestablish sound stability data for herbal products and predicttheir shelf life which will help in global acceptabilityof herbalproducts.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
This document provides information on the preparation and potency determination of oxytocin and human antihaemophilic vaccine. It describes that oxytocin is obtained from pituitary glands and stimulates uterine contraction and milk ejection. Its potency is determined by comparing its activity to a standard preparation in assays measuring blood pressure depression in chickens. The document also describes that human antihaemophilic vaccine is prepared from human plasma to be rich in clotting factor VIII. Its potency is determined by comparing the amount needed to reduce clotting time to that of a standard preparation in an assay using citrated plasma.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses pharmaceutical validation including definitions of qualification and validation. It provides details on types of qualification including design, installation, operational and performance qualification. Validation types such as prospective, concurrent and retrospective validation are summarized. The importance of validation master plan and validation protocols are highlighted. Key aspects of streamlining validation operations are also covered such as the importance of parallel development of API, analytical methods and drug product.
This document discusses stability testing of pharmaceutical packaging. Stability testing ensures that packaging maintains the quality of drugs over time under various environmental conditions like temperature, humidity and light. It involves testing packaging for leakage, strength, impact of distribution processes, and compatibility with drugs. The document outlines guidelines for conducting stability tests, including storage conditions, timepoints for sampling, and parameters to evaluate like appearance, assay and degradation. The goal is to determine shelf life and ensure patient safety.
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
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.
In process & finished products quality control test for pharmaceuticalsSuraj Ghorpade
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for pharmaceutical products. It defines IPQC and outlines its objectives to optimize processes, monitor operations, and inspect raw materials, equipment, environment and more. Key IPQC tests are described including physical/chemical tests (identity, quality, purity, potency), biological/microbiological tests. Specific IPQC parameters and checks are provided for tablets, including tests for size/shape, color, thickness, assay, dissolution and more. Acceptance criteria are defined according to pharmacopeial standards. The importance of IPQC for ensuring quality products is emphasized.
Group No. 7 presented their topics for quality control. Yash Kokate chose Quality Circle, Aditya Kshirsagar chose Quality Management, and others chose related topics such as Quality Assurance and Quality Control, Objectives of Quality Control, Components of Quality Control, and Steps in Quality Control.
The document then discusses the importance of quality control in the pharmaceutical industry and defines quality assurance. It states that a high quality pharmaceutical product is one that is both safe and effective, of consistent composition, and free of contaminants. It impacts both the producer and consumer. The quality control department ensures patient health is not compromised and protects the company's reputation.
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
The document summarizes a product development review meeting discussing the drug Prucalopride for the treatment of chronic idiopathic constipation. The summary includes:
- Prucalopride is a serotonin type 4 receptor agonist proposed for the treatment of chronic idiopathic constipation.
- The drug substance and drug product manufacturing processes and controls were reviewed, including specifications and stability data.
- Potential risks from a quality perspective were evaluated and determined to be low to none, considering characterization of materials and controls during manufacturing and testing.
In Process And Final Product Quality Control Test For CapsulesAkshita Dholakiya
The document discusses in-process quality control testing that is performed on hard and soft gelatin capsules during the manufacturing process, including physical tests like disintegration testing and weight variation testing, and chemical tests like dissolution testing, assay testing, and content uniformity testing to ensure the quality of capsules meets specifications. It provides details on the types of tests, acceptance criteria for tests, and equipment used to perform various quality control tests at different stages of the capsule manufacturing process.
Quality control and quality assurance are important concepts for ensuring food safety. Quality control involves evaluating the final product to check that it meets standards, while quality assurance is a systematic approach to preventing issues and providing confidence that products will meet requirements. Food safety aims to ensure food will not harm consumers and differs from other quality attributes as safety issues can be difficult to observe. Proper quality control, assurance practices and attention to food hazards help protect public health.
This document discusses quality control of drugs and pharmaceuticals. It defines quality control as the inspection aspect of quality management that focuses on fulfilling quality requirements. Quality control ensures drugs are safe, effective, and consistent by testing raw materials, in-process materials, and finished products. It describes various analytical testing methods used in quality control like qualitative analysis, quantitative analysis, dissolution testing, disintegration testing, hardness testing, friability testing, and content uniformity testing. Sources of errors in pharmaceutical analysis and sources of impurities in drugs are also discussed.
The document summarizes the key aspects of in-process quality control (IPQC), release of finished products, and related quality control procedures. It defines IPQC and discusses the various tests involved at different stages of production. These include physical, chemical, biological, and microbiological testing. It also outlines the documentation required for batch release, including quality review, auditing, and maintaining distribution records. The presentation provides an overview of quality control measures from raw material receipt through finished product release.
Quality Control Assurance Management.pptxMuntasir18
Quality control, quality assurance, and food safety are important concepts. Quality control evaluates final products to assign quality categories, but has limited ability to improve quality. Quality assurance is a planned, systematic approach to provide confidence that products and services will meet requirements. It focuses on how processes are performed. Food safety ensures food will not harm consumers when prepared properly. Responsibilities of quality assurance include ensuring quality policies are followed and products meet specifications. Quality control conducts testing and inspection. Proper control of raw materials, in-process items, and manufacturing variation are important to maintain quality and safety.
Quality control, quality assurance, and food safety are important concepts. Quality control evaluates final products to assign quality categories, but has limited ability to improve quality. Quality assurance is a planned, systematic approach to providing confidence that products and services will meet requirements. It focuses on how processes are performed. Food safety provides assurance that food will not harm consumers when prepared and eaten as intended. Responsibilities of quality assurance include ensuring quality policies are followed and products meet specifications.
PST-392 Introduction to Quality Assurance (1).pptxYunesalsayadi
Introduction to Quality assurance.
According to U.S.F.D.A
“Quality should be built into the product, and testing alone cannot be relied on to ensure product quality”.
Building Quality into the product involves having controls at every stage of manufacturing and not only terminal controls.
These include controls on all input resources like:
people,
facilities,
equipment,
materials,
process
and testing etc.
The document discusses quality assurance (QA) and quality control (QC) in the pharmaceutical industry. It defines QA as the organized arrangements to ensure products meet quality requirements for intended use. GMP is part of QA focused on consistently manufacturing products to a quality appropriate for intended use. QC is the part of GMP concerned with sampling, specifications, testing, documentation, and release procedures to ensure necessary tests are performed and products meet quality standards before release. The document emphasizes that QA is company-based while QC is laboratory-based and operational. It provides guidelines for establishing acceptance criteria for various quality attributes like impurities, degradation products, particle size, and polymorphism in drug substances and drug products.
validation of tablet and capsule formulation8tanvikumbhar
This document discusses types of process validation for pharmaceutical manufacturing. It describes prospective, retrospective, and concurrent validation. Prospective validation involves validating a new process before use by following a validation protocol. Retrospective validation analyzes historical data from established stable processes. Concurrent validation monitors critical parameters during production. The document also discusses validation of tablet and capsule manufacturing processes. Key parameters include composition, mixing/blending, granulation, drying, milling, lubrication, compression/filling, and testing. Process validation ensures consistent quality and safety of dosage forms.
The document discusses the process of developing, optimizing, characterizing, and commercializing a pharmaceutical product. It involves designing a manufacturing process to consistently deliver the intended effects of the drug product. Process development includes determining facility, equipment, materials, procedures, and validation. Optimization compares lead compounds to select those with the greatest potential to be safe and effective medicines. Characterization tests understand the physical and chemical properties of materials. Commercialization requires approvals from regulators and establishing manufacturing, distribution, and marketing capabilities to introduce the product into markets. The goal is to produce a drug that is safe, effective, and affordable to improve patient health.
INDUSTRIAL TRAINING REPORT (B-pharmacy ) Zentiva pharmaceutical industry PrakashKumar721
Location:- GIDC Estate Ankleswar
393002, Dist. Bharuch ,Gujrat India
Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4,700 people and a network of production sites - including flagship sites in Prague, Bucharest and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better supportpeople’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators and governments to provide the everyday solutions that we all depend on.
About Zentiva’s Ankleshwar site
Established in 1987, the Ankleshwar manufacturing site has a chemistry and biotechnology development center, and manufactures both intermediates and pharmaceutical formulations. A large producer of tablets, the Ankleshwar site manufactures more than 6 billion tablets annually.
Mission &Values:-
Zentiva is a leading developer and supplier of high-quality affordable prescription medicines and consumer brands. As Zentiva grows more people get the medicine they need. Our business is built on trust and responsibility with the patient at the heart of everything we do. Zentiva has established 6 shared SuperpowerZ which frame the values and behaviours we expect of our team and how we will build a healthy business that we can all be proud of.
TABLET-SECTION
Tablet:-
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life.
Advantage
• Production aspect
Large scale production at lowest cost
Easiest and cheapest to package and ship
High stability
• User aspect (doctor, pharmacist, patient)
Easy to handling.
Lightest and most compact.
Greatest dose precision & least content variability.
Coating can mark unpleasant tastes & improve pt. acceptability.
PHARMACEUTICAL PRODUCT BY ZENTIVA PHARMACEUTICAL PVT.LTD:-
1. Avil -25 mg
2. Trental-400
3. Paracetamol-500mg
4. Ramilich-( 5, 25mg)
5. Ramipril-25mg
6. Zuglimate-500mg
7. Clopidogrel-75mg
8. Metformin-100mg
QUALITY CONTROL AND QUALITY ASSUARANCE
Quality control is the part of GMP that deals with sampling, specification, and testing, as well as organisation, documentation, and release procedures to ensure that necessary and
Similar to 3. Section-IN PROCESS QUALITY CONTROL and QUALITY CONTROL.pdf (20)
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2. 3. IN PROCESS QUALITY CONTROL
and QUALITY CONTROL MEASURES
IN PHARMACEUTICAL INDUSTRY
2
3. QUALITY CONTROL
Definition
Quality control refers to the sum of all
procedures undertaken to ensure the identity
and purity of a particular pharmaceutical
product.
quality control
4. QUALITY CONTROL
Quality control is an essential operation of
the pharmaceutical industry.
Drugs must be marketed as safe and
therapeutically active formulations
Quality is the result of intelligent effort.
The quality in the pharmaceutical industry has
become a very important and sensitive issue.
THE IMPortance of quality and control of
quality
5. QUALITY CONTROL
The goal of the pharmaceutical quality control
testing process is to produce satisfactory
results by investigating and monitoring the
quality of manufacturing pharmaceutical in
accordance with compendial standards and
specifications.
THE IMPortance of quality and control of
quality
6. QUALITY CONTROL
The quality of pharmaceutical products is essential to
assure the maximum level of patient’s satisfaction.
The most important criteria for quality of any drug in
dosage form are its safety, potency, efficacy, stability,
patient acceptability and regulatory compliance.
THE IMPortance of quality and control of
quality
7. QUALITY CONTROL
Counterfeit medicines;
The WHO defines a counterfeit drug as a product
that is with intent and illegally mislabelled with
respect to its identity and/or source.
Counterfeiting of medicinal products, active
pharmaceutical ingredients or product labels are
criminal offences, which may endanger patient
health.
THE IMPortance of quality and control of
quality
8. QUALITY CONTROL
Counterfeit medicines may:
► contain no active ingredient
► contain the wrong active ingredient
► contain an incorrect quantity of the active ingredient
► be in low–quality packaging
► be manufactured using low–quality active ingredient
or excipient
► be manufactured under poor standards of good
manufacturing practice compliance.
9. QUALITY CONTROL
Counterfeit medicines may:
► contain no active ingredient
► contain the wrong active ingredient
► contain an incorrect quantity of the active ingredient
► be in low–quality packaging
► be manufactured using low–quality active ingredient
or excipient
► be manufactured under poor standards of good
manufacturing practice compliance.
10. QUALITY CONTROL
Counterfeit medicines may:
► contain no active ingredient
► contain the wrong active ingredient
► contain an incorrect quantity of the active ingredient
► be in low–quality packaging
► be manufactured using low–quality active ingredient
or excipient
► be manufactured under poor standards of good
manufacturing practice compliance.
11. Quality control is an essential operation of
the pharmaceutical industry.
New and better medicinal agents are being
produced at an accelerated rate. At the same
time more exacting and sophisticated
analytical methods are being developed for
their evaluation.
11
12. Quality Control in the pharmaceutical
industry is required for :
Raw Materials and API:
Finished Products :
Packaging Components :
12
13. When the quality of any drug is given by industry, then
it is responsible for any variation from the standard.
Quality Variation may occur due to any mistake during
the whole process i.e. from the reception of raw
material up to the final product in the packaged form.
The risk of error increases as the material increases
and the method become very complicated..
13
14. Improvement of the quality of production and
reduction in the production cost.
Uniformity in the production and supply of standard
quality goods to consumers.
Offering full return of the price paid by the
consumers and giving convenience and satisfaction to
consumers .
14
15. Reduction in spoiled production and rejection from
consumers and dealers.
Promotion of exports due to superior and standard
quality production.
Reduction in inspection cost.
Making products popular in market.
15
17. Organoleptic tests:
are conducted to determine if the
pharmaceutical products can transfer tastes
or odors to the materials and components they
are packaged in
17
19. QUALITY CONTROL
To further enhance the effectiveness and
safety of the drug product after approval, many
regulatory agencies such as
the United States Food and Drug
Administration (FDA) also require that the drug
product be tested for its identity, strength,
quality, purity and stability before it can be
20. IN PROCESS QUALITY CONTROL
IPQC (in process
quality control)
These are checks that
are carried out before
the manufacturing
process is completed.
Rejected in-process
materials should be
identified and
controlled under a
quarantine system
21. IN PROCESS QUALITY CONTROL
IPQC (in process quality control)
In process Quality Control, IPQC tests are mostly
performed within the production area.
The control of the environment or equipment may also
be regarded as a part of in process control (IPC).
They should not carry any risk for the quality of
product.
In process testing enables easier identification of
problems.
Failure to meet In process control specification
indicates either that procedure were not followed or
some factor were out of control.
Standard operating procedures (SOPs) should be
established in the pharmaceutical industry and followed
that describe the IPQCs and tests
22. IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
I.P.Q.C TESTS FOR TABLETS
IPQC TESTS FOR COATED TABLET
IPQC TESTS FOR CAPSULES:
I.P.Q.C TESTS FOR SYRUPS AND SUSPENSION
I.P.Q.C TESTS FOR SEMI- SOLIDs
I.P.Q.C TESTS FOR INJECTABLES
23. IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
IPQC TESTS OF TABLETS
• Weight variation of tablets.
• Hardness of tablets.
• Thickness.
• Friability.
• Uniformity of content.
• Disintegration time.
• Dissolution test.
• Content of active ingredients.
24. IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
IPQC TESTS FOR COATED TABLET
• Moisture content of dried granulation
• Granulation particle size distribution
• Blend uniformity
• Individual tablet/capsule weight
• Hardness
• Thickness
• Disintegration
• Impurity profile
25. IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
IPQC TESTS FOR CAPSULES:
• Assay.
• Weight variation test.
• Disintegration time.
• Dissolution time.
• Moisture test.
• Iron test.
• Hardness and flexibility of shell.
• Loss on drying.
• Stability test at different temperature.
26. QUALITY CONTROL EQUIPMENTS
Drug Content Determination
A physically sound tablet may not produce the desired
effects. To evaluate a tablet potential for efficiacy, the
amount of drug per tablet needs to be monitored from
tablet to tablet and batch to batch, and a measure of
the tablets ability to release the drug needs to be
ascertained.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
27. QUALITY CONTROL EQUIPMENTS
Moisture Content of granules
Granules should possess sufficient strength to
withstand normal handling and mixing processes
without breaking down and producing large amounts of
fine powder.
On the other hand, some size reduction during
compaction into tablets is desirable to expose the areas
of clean surface necessary for optimum bonding to take
place so moisture content is the very important factor
for producing good pharmaceutical product.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
28. QUALITY CONTROL EQUIPMENTS
Assay of active ingredient
In a tablet an active ingredient is present which
is called active pharmaceutical ingredient
(A.P.I).
So to prepare the tablet assay has to be done
to produce good finished product.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
29. QUALITY CONTROL EQUIPMENTS
Hardness test
The monitoring of tablet hardness is especially
important for drug products that possess real
or potential bioavailability problems that are
sensitive to altered dissolution release profiles
as a function of the compressive force
employed .
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
30. QUALITY CONTROL EQUIPMENTS
Disintegration test
A generally accepted maximum is that drug to
be readily available to the body, it must be in
solution.
For most tablets, the first important step
towards solution is break down of the tablet
into smaller particles or granules, a process
known as disintegration.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
31. QUALITY CONTROL EQUIPMENTS
I.P.Q.C TEST FOR SYRUPS AND SUSPENSION
a) Drug contents determination.
b) Assay of active ingredients.
c) pH.
d) Weight per ml.
e) particle size
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
32. QUALITY CONTROL EQUIPMENTS
Drug content determination
Determination of drug content in suspension and
syrups are important because their
concentration has to be sufficient itself that it
produce the pharmacological action.
A suspension is much prescribed to pediatrics
so their concentration has to be sufficient not
to less not to large.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
33. QUALITY CONTROL EQUIPMENTS
Assay of active ingredient
Active ingredient means pure drug present in
the product .An assay of active ingredient must
be done because it is the only which is
responsible for pharmacological action and in
syrups and suspension a small and fine particles
are included in syrups and suspension
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
34. QUALITY CONTROL EQUIPMENTS
pH of the product
pH affects the stability of the product so
before filling and after filling of suspension and
syrups pH has to be checked out for
consistency of the product.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
35. QUALITY CONTROL EQUIPMENTS
Particle size
In suspension and syrups a solute particles is
dispersed in a suitable solvent so particle size
becomes the important factor for the
suitability of the product and all the particles
has to be of same size and shape for proper
dispersing in the solvent
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
36. QUALITY CONTROL EQUIPMENTS
I.P.Q.C TEST FOR SEMI- SOLIDs
a) Drug contents determination.
b) Assay of active ingredients.
c) Uniformity and homogeneity test.
d) Viscosity and specific gravity test.
e) Filling test.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
37. QUALITY CONTROL EQUIPMENTS
Homogenecity test
The semi-solid preparations require further
treatment are transferred or pumped to the
proper homogenizer, the selection of which is
governed by the degree and rate of shear
stress required.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
38. QUALITY CONTROL EQUIPMENTS
Viscosity and Specific gravity test
Once the desired semi-solid preparation have
been chosen, a consistency that provides the
desired stability and has appropriate flow
characterstics must be attained. For emulsion it
is routinely observed that the building up of
viscosity in a freshly prepared emulsion requires
some time.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
39. QUALITY CONTROL EQUIPMENTS
I.P.Q.C TEST FOR INJECTABLES
a) Drug contents determination.
b) Clarity test.
c) pH.
d) Pyrogen test.
e) Sterility test.
f) Leakage test.
g) Check up of particulate matters.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
40. QUALITY CONTROL EQUIPMENTS
Pyrogen test
The presence of pyrogenic substance in
parenterals is determined by a qualitative
biologic test based on the fever response of
the rabbits.
Rabbits are used as test animal because they
show a physiologic response to pyrogens similar
to that of human beings. If a pyrogenic
substance is injected into the vein of a rabbit,
an elevation of temperature occurs in a period
of three hours.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
41. QUALITY CONTROL EQUIPMENTS
Sterility test
All products labeled “sterile” must pass through
sterility test, having been subjected to an
effective process of sterilization
.
With a terminal methods of sterilization of a
parenteral product, particularly steam under
pressure, a probability of no more than one
sterile unit in a million is readily achievable.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
42. QUALITY CONTROL EQUIPMENTS
Leaking test
Ampules are intended to provide sealed
container for a single dose of a product,
thereby completely barring any interchange
between the contents of the sealed ampule and
its environment.
Should capillary pores or tiny cracks be
present, microorganisms or other dangerous
contaminants may enter the ampule or the
contents may leak to the outside and spoil the
appearance of the package.
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
43. QUALITY CONTROL EQUIPMENTS
Clarity test
Clarity is the relative term, the meaning of which is
markedly affected by the subjective evaluation of the
observer. Unquestionly a clean solution having a high
polish conveys to the observer that the product is of
exceptional quality and purity.
This clarity test is performed in industry by visual
inspection machine by the light baffles against
reflection into the eyes, and views against a black and
white background, with the contents set in motion with
a swirling action
IPQC TESTS FOR VARIOUS DOSAGE
FORMS:
45. According to BRITISH PHARMACOPOEIA QUALITY
CONTROL TEST
FOR ALL TABLETS:
• Content of active ingredients
• General Appearance
• Disintegration (coated, uncoated & effervescent
tablet)
• Uniformity of weight
• Uniformity of content
• Dissolution test
• Uniformity of dispersion (for dispersible tablet)
• Tablet diameter
PHARMACOPOEIAL QUALITY CONTROL TESTS:
46. QUALITY CONTROL EQUIPMENTS
General Appearance:
Size, shape, and thickness:
This is important to facilitate packaging and to decide
which tablet compressing machine to use.
Organoleptic properties:
include color and odor of the tablets.
Weight uniformity and content uniformity:
This test is to ensure that every dosage form contains
equal amount of drug substance i.e. active
pharmaceutical ingredient within a batch.
QUALITY CONTROL TESTS FOR TABLETS:
47. QUALITY CONTROL EQUIPMENTS
QUALITY CONTROL TESTS FOR TABLETS:
Dissolution test:
Drug should be released from tablet in a controlled and
reproducible way.
Weight variation, thickness & diameter:
The appearance of tablet should be elegant & its
weight, size & appearance should be consistent.
Hardness & friability: The tablet should show
sufficient mechanical strength to withstand fracture
& erosion during manufacture & handling.
PHARMACOPOEIAL QUALITY CONTROL
TESTS:
QUALITY CONTROL TESTS FOR TABLETS:
48. QUALITY CONTROL EQUIPMENTS
comparison of different pharmacopoeial quality control
tests :
BRITISH PHARMACOPOEIA:
FOR ALL TABLETS:
Content of active ingredients
Disintegration
Uniformity of content
Labeling
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
49. QUALITY CONTROL EQUIPMENTS
Uncoated tablet:
- Disintegration test
- Uniformity of weight
Effervescent tablet:
- Disintegration test
- Uniformity of weight
Coated tablet:
- Disintegration test
- Uniformity of weight
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
50. QUALITY CONTROL EQUIPMENTS
Gastro resistant tablet:
- Disintegration test
Modified release tablet:
- Uniformity of weight.
Dispersible tablet:
- -Disintegration test
- - Uniformity of dispersion
- - Uniformity of weight
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
51. QUALITY CONTROL EQUIPMENTS
INDIAN PHARMACOPOEIA :
Uncoated tablet:
-Uniformity of container content
-Content of active ingredient
-Uniformity of weight
-Uniformity of content
-Disintegration test
Enteric coated tablet:
- Disintegration test
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
52. QUALITY CONTROL EQUIPMENTS
Dispersible tablet:
-Uniformity of dispersion
-Disintegration
Soluble tablet:
-Disintegration test
Effervescent tablet:
-Disintegration/ Dissolution / Dispersion test
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
53. QUALITY CONTROL EQUIPMENTS
UNITED STATES PHARMACOPOEIA:
Physical tests applicable to tablet formulation:
-Bulk density /Tapped density of powder
-Powder fineness
-Loss on drying
-Disintegration test
-Tablet friability
-Dissolution test
-Drug release testing
-Uniformity of dosage form
-Container permeation test
-Labeling of inactive ingredients
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
54. QUALITY CONTROL EQUIPMENTS
OFFICIAL AND UNOFFICIAL TESTS:
Official Tests:
uniformity of active ingredient,
disintegration,
dissolution.
Non-Official Tests:
Hardness,
friability.
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
55. QUALITY CONTROL EQUIPMENTS
1-NON OFFICIAL TESTS:
HARDNESS (CRUSHING STRENGTH):
It measures crushing strength property defined as
compressional force applied diametrically to a tablet
which just fracture it.
Why do we measure hardness?
To determine the need for pressure adjustments on
the tableting machine.
Hardness can affect the disintegration.
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
56. QUALITY CONTROL EQUIPMENTS
Results:
In general, if the tablet hardness is too high, we first
check its disintegration before rejecting the patch.
And if the disintegration is within limit, we accept the
patch.
If hardness is high + disintegration is within time we
accept the batch .
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
57. QUALITY CONTROL EQUIPMENTS
FRIABILITY:
The tablet may well be subjected to a tumbling motion.
For e.g: Coating, packaging, transport, which are not
severe enough to break the tablet, but may abrade the
small particle from tablet surface.
To examine this, tablets are subjected to a uniform
tumbling motion for specified time and weight loss is
measured.
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
58. QUALITY CONTROL EQUIPMENTS
OFFICIAL TESTS:
DISINTEGRATION:
It is the time required for the tablet to break into
particles, the disintegration test is a measure only of
the time required under a given set of conditions for a
group of tablets to disintegrate into particles
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
59. QUALITY CONTROL EQUIPMENTS
Uniformity of Active Ingredients:
It is measured to ensure a constant dose of drug
between individual drugs
Traditionally, dose variation between tablet is tested
in two separate tests namely
A) Weight variation
B) Content uniformity
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
60. QUALITY CONTROL EQUIPMENTS
DISSOLUTION TEST:
The release of drug from the tablet into solution per
unit time under standardize condition is called
dissolution test.
Media used in dissolution testing may be purified
water, simulated gastric fluid, simulated intestinal
fluid or others. Organic solvents are not
recommended.
The most commonly used are USP apparatus I
(basket) and USP apparatus II (paddle).
OFFICIAL STANDARDS AS PER B.P. /I.P./
U.S.P.:
62. Whether capsules are produced on a small scale or
large scale all of them are required to pass through
certain tests i.e., quality control tests to test the quality
of the finished product.
Quality control of capsules
63. Quality control tests are
divided into
PHYSICAL TEST
• Disintegration test
• Weight variation
CHEMICAL TEST
• Dissolution test
• Assay
• Content uniformity
• Moisture permeation test
Quality control of capsules
65. Quality control tests for
parenterals
Uniformity of content
Test for volume of liquid
Test for pyrogen
Test for sterility
Clarity of solution
Uniformity of weight
Test for bacterial endotoxin
Leakage test
66. Uniformity of content
30 sterile units are selected from each batch.
• The weight of 10 individual sterile units is noted and the content is removed
from them and empty individual sterile unit is weighed accurately again.
• Then net weight is calculated by subtracting empty sterile unit weight from
gross weight.
• The dose uniformity is met if the amount of active ingredient is within the range
of 85-115.0% of label claim. UNIFORMITY OF CONTENT
67. Quality control tests for
parenterals
Relative standard deviation is equal to or less than
6.0%.
If one unit is outside the range of 85-115.0%, and none
of the sterile unit is outside the range of 75-125.0% or
if the relative standard deviation of the resultant is
greater than 6.0% ,or if both condition prevail, an
additional 20 sterile unit should be tested.
The sterile units meet the requirements if not more
than one unit is out side the range of 85-115%, no unit
is outside the range of 75-125.0% and the calculated
relative standard deviation is 7.8%.
Uniformity of content
68. TEST FOR VOLUME OF LIQUID
Test applies to liquid supplied in single dose ,
only part of the content is used
Empty the contents of one container&
determine the volume of contents
Emulsions & suspensions shake the container
before the determination
The volume is not less than the amount stated
on the label.
70. Leakage test
Leakage test is employed to test the package
integrity.
Package integrity reflects its ability to keep the
product in and to keep potential contamination
out.
Which is the flow of matter through the barrier
itself.
1. using methylene blue solution
2. spark test
71. Leakage test
Leakage Test (with methylene blue solution):
The ampoules are immersed in vacuum chamber
consisting of 1% methylene blue solution
A vacuum of about 27 inch Hg is created for about 15
to 30 min.
This causes the solution to enter the ampoules with
defective sealing.
The vacuum is released and ampoules are observed.
If a leakage is present, the solution in the ampoules
appear blue color.
73. Leakage test
Spark Test:
The machine uses high precision electrodes to inspect
the full circumference of the containers, including the
closure zone.
All containers are presented individually to the
electrodes.
Any moisture that has penetrated through capillary
forces in a crack, pinhole or just weak glass is
registered as a change in resistance.
All products with a measured voltage higher than a
defined maximum value are separated from the good
products.