To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
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 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 Parenterals - By Kaleem PetkarKaleem Petkar
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
The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product.
The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by micro-organisms that may be introduced inadvertently during or subsequent
to the manufacturing process.
However, antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing procedures.
There may be situations where a preservative system may have to be used to minimise proliferation of micro-organisms in preparations that are not required to be sterile.
NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP A...roshan telrandhe
Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to the eyes in the space between eye lids and eye ball .
These product must be sterile and are prepare under the same condition as that of parenteral preparation
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.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
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 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 Parenterals - By Kaleem PetkarKaleem Petkar
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
The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product.
The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by micro-organisms that may be introduced inadvertently during or subsequent
to the manufacturing process.
However, antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing procedures.
There may be situations where a preservative system may have to be used to minimise proliferation of micro-organisms in preparations that are not required to be sterile.
NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP A...roshan telrandhe
Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to the eyes in the space between eye lids and eye ball .
These product must be sterile and are prepare under the same condition as that of parenteral preparation
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.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
This document discusses in-process quality control (IPQC) for various dosage forms including tablets, capsules, liquids, ointments, and parenterals. It provides details on common IPQC tests for each dosage form, such as hardness testing, friability testing, weight variation, disintegration, and dissolution for tablets. Specific steps in sterility testing and leak testing are also outlined for ensuring the quality of sterile parenteral products during manufacturing. The document emphasizes that IPQC is important to monitor processes, make adjustments to ensure product quality meets specifications, and avoid wasted efforts from non-compliant batches.
Evaluation Of Ocular Drug Delivery SystemAnal Mondal
This document discusses evaluation methods for ocular drug delivery systems. It describes various techniques to test the thickness, drug content uniformity, weight uniformity, and moisture absorption of ocular films. Dissolution testing methods are also summarized, including bottle, diffusion, rotating basket, and rotating paddle methods. In vivo testing in animal eyes is described. Accelerated stability testing aims to predict stability over prolonged storage. Additional tests include checking for metal particles in ointments and performing sterility testing and leakage testing of ointment tubes.
IPQC Tests for Opthalmic Preparations.pptxSohailSheikh62
The document discusses quality control testing for ophthalmic pharmaceutical preparations. It outlines 8 key tests: 1) pH, 2) isotonicity, 3) therapeutic efficacy, 4) compatibility with the eye, 5) clarity, 6) particulate matter, 7) bacterial endotoxins, and 8) sterility. Each test is important to ensure the safety, stability and effectiveness of ophthalmic drugs. The document provides details on acceptable ranges and testing methods for each quality control parameter based on pharmacopoeial standards.
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
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.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
IPQC and FPQC tests are important for ensuring quality of creams, parenterals, and ophthalmic products.
Key IPQC tests for these products include physical tests like rate of absorption and irritancy tests, as well as microbiological tests like testing for microbial growth. FPQC tests focus on sterility, clarity, content uniformity, and ensuring the products meet specifications.
Stability studies per ICH guidelines are also important to test products under different storage conditions and ensure quality is maintained throughout shelf life. Proper IPQC and FPQC help guarantee patient safety and product efficacy.
Development of analytical method by RP-HPLC for marketed drug formulation in ...Ashish Chaudhari
The document describes the development of an analytical method using RP-HPLC to quantify a drug in rat plasma. It discusses literature searching for similar methods, selecting the drug and analytical technique, optimizing the method, and validating the method parameters like accuracy, precision, selectivity and stability. The goal is to develop a sensitive, reproducible and accurate bioanalytical method that can be used to determine drug concentration in plasma samples for pharmacokinetic studies.
The document describes procedures for testing the sterility of pharmaceutical products. It provides details on culture media, incubation temperatures, strains of test microorganisms, and the sterility test method. The key points are:
- Two common culture media are described for detecting bacteria (Fluid Thioglycollate Medium) and fungi/bacteria (Soybean-Casein Digest Medium).
- Samples are inoculated into media and incubated at specified temperatures, then examined for microbial growth which would indicate a failed sterility test.
- The sterility test method and number of samples tested depends on the type and amount of product available for testing.
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.
1. The document discusses in-process quality control (IPQC) and finished product quality control (FPQC) tests for pharmaceutical capsules according to various pharmacopoeias. It describes 12 key tests including appearance, size, assay, content uniformity, dissolution, and stability testing.
2. The tests evaluate physical parameters like temperature, humidity, weight, and disintegration time. They also assess the content of active ingredients and whether capsules meet specifications for content uniformity, dissolution rate, and stability over time.
3. Ensuring quality through comprehensive testing during and after production is important for regulatory compliance and producing safe, effective pharmaceuticals. The various pharmacopoeias have different standards and requirements but collectively
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.
This document outlines preformulation studies conducted on the drug metronidazole, including characterization of its physical properties, solubility, stability, and compatibility with excipients. Key aspects that were evaluated include particle size, bulk density, angle of repose, pH, partition coefficient, stability under various conditions like temperature, humidity and light. Drug-excipient compatibility was also studied by storing mixtures at elevated temperature and observing for physical or chemical changes. The goal of these studies is to understand the drug's characteristics and behavior to aid in rational formulation design and selection of appropriate excipients and storage conditions.
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.
This document discusses the scale-up considerations for producing parenteral drugs on a pilot plant scale. It describes the key unit operations in parenteral production as mixing, sterilization, filtration, filling and sealing. For each unit operation, parameters that must be considered for scale-up are identified, such as tank size and type, impeller design, membrane size, filling rate and container size. Maintaining sterility and avoiding issues like precipitation or clogging are important challenges addressed during scale-up. Quality control tests are used to evaluate the scaled processes. Proper scale-up allows efficient transition from laboratory to commercial production of injectable drug products.
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.
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.
Modified resazurin microtiter assay for in vitro assessment of different anti...VRUSHALI KALEKAR
1) The document describes developing a microtiter plate-based assay using resazurin dye to test the susceptibility of pathogens to different antimicrobials.
2) Standardization experiments were conducted to determine the optimal bacterial concentration, dye concentration, and incubation times for common pathogens. A concentration of 106 cfu/ml bacteria and 0.5mM resazurin dye were found to give reliable results within 4-16 hours.
3) The developed assay was validated by testing 20 E. coli clinical isolates against various antibiotics and comparing results to standard disc diffusion testing. Most results matched between the two methods.
2.6.12. microbiological examination of non sterile products (total viable aer...Guide_Consulting
This document provides instructions for performing a total viable aerobic count test to quantify bacteria and fungi that may be present in non-sterile pharmaceutical products. The test involves preparing samples from the product, then examining the samples using membrane filtration or plate counting methods to determine the number of colony forming units per gram or milliliter of product. Specific steps are outlined for preparing water-soluble products, non-fatty insoluble products, fatty products, and transdermal patches. The document also provides details on conducting membrane filtration, pour plate, surface spread, and most probable number examination methods and calculating results.
This document summarizes quality control tests for various pharmaceutical products including parenterals, ophthalmic products, and surgical products. For parenterals, key tests discussed include sterility testing using direct transfer and membrane filtration methods, pyrogen testing using rabbit and LAL methods, leaker testing, and particulate matter testing. For ophthalmic products, tests outlined are for ocular toxicity/irritancy, preservative efficacy, particle size, sterility, and metal particles. Quality control of surgical products involves testing for acceptable materials and freedom from defects.
This document discusses in-process quality control (IPQC) for various dosage forms including tablets, capsules, liquids, ointments, and parenterals. It provides details on common IPQC tests for each dosage form, such as hardness testing, friability testing, weight variation, disintegration, and dissolution for tablets. Specific steps in sterility testing and leak testing are also outlined for ensuring the quality of sterile parenteral products during manufacturing. The document emphasizes that IPQC is important to monitor processes, make adjustments to ensure product quality meets specifications, and avoid wasted efforts from non-compliant batches.
Evaluation Of Ocular Drug Delivery SystemAnal Mondal
This document discusses evaluation methods for ocular drug delivery systems. It describes various techniques to test the thickness, drug content uniformity, weight uniformity, and moisture absorption of ocular films. Dissolution testing methods are also summarized, including bottle, diffusion, rotating basket, and rotating paddle methods. In vivo testing in animal eyes is described. Accelerated stability testing aims to predict stability over prolonged storage. Additional tests include checking for metal particles in ointments and performing sterility testing and leakage testing of ointment tubes.
IPQC Tests for Opthalmic Preparations.pptxSohailSheikh62
The document discusses quality control testing for ophthalmic pharmaceutical preparations. It outlines 8 key tests: 1) pH, 2) isotonicity, 3) therapeutic efficacy, 4) compatibility with the eye, 5) clarity, 6) particulate matter, 7) bacterial endotoxins, and 8) sterility. Each test is important to ensure the safety, stability and effectiveness of ophthalmic drugs. The document provides details on acceptable ranges and testing methods for each quality control parameter based on pharmacopoeial standards.
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
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.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
IPQC and FPQC tests are important for ensuring quality of creams, parenterals, and ophthalmic products.
Key IPQC tests for these products include physical tests like rate of absorption and irritancy tests, as well as microbiological tests like testing for microbial growth. FPQC tests focus on sterility, clarity, content uniformity, and ensuring the products meet specifications.
Stability studies per ICH guidelines are also important to test products under different storage conditions and ensure quality is maintained throughout shelf life. Proper IPQC and FPQC help guarantee patient safety and product efficacy.
Development of analytical method by RP-HPLC for marketed drug formulation in ...Ashish Chaudhari
The document describes the development of an analytical method using RP-HPLC to quantify a drug in rat plasma. It discusses literature searching for similar methods, selecting the drug and analytical technique, optimizing the method, and validating the method parameters like accuracy, precision, selectivity and stability. The goal is to develop a sensitive, reproducible and accurate bioanalytical method that can be used to determine drug concentration in plasma samples for pharmacokinetic studies.
The document describes procedures for testing the sterility of pharmaceutical products. It provides details on culture media, incubation temperatures, strains of test microorganisms, and the sterility test method. The key points are:
- Two common culture media are described for detecting bacteria (Fluid Thioglycollate Medium) and fungi/bacteria (Soybean-Casein Digest Medium).
- Samples are inoculated into media and incubated at specified temperatures, then examined for microbial growth which would indicate a failed sterility test.
- The sterility test method and number of samples tested depends on the type and amount of product available for testing.
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.
1. The document discusses in-process quality control (IPQC) and finished product quality control (FPQC) tests for pharmaceutical capsules according to various pharmacopoeias. It describes 12 key tests including appearance, size, assay, content uniformity, dissolution, and stability testing.
2. The tests evaluate physical parameters like temperature, humidity, weight, and disintegration time. They also assess the content of active ingredients and whether capsules meet specifications for content uniformity, dissolution rate, and stability over time.
3. Ensuring quality through comprehensive testing during and after production is important for regulatory compliance and producing safe, effective pharmaceuticals. The various pharmacopoeias have different standards and requirements but collectively
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.
This document outlines preformulation studies conducted on the drug metronidazole, including characterization of its physical properties, solubility, stability, and compatibility with excipients. Key aspects that were evaluated include particle size, bulk density, angle of repose, pH, partition coefficient, stability under various conditions like temperature, humidity and light. Drug-excipient compatibility was also studied by storing mixtures at elevated temperature and observing for physical or chemical changes. The goal of these studies is to understand the drug's characteristics and behavior to aid in rational formulation design and selection of appropriate excipients and storage conditions.
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.
This document discusses the scale-up considerations for producing parenteral drugs on a pilot plant scale. It describes the key unit operations in parenteral production as mixing, sterilization, filtration, filling and sealing. For each unit operation, parameters that must be considered for scale-up are identified, such as tank size and type, impeller design, membrane size, filling rate and container size. Maintaining sterility and avoiding issues like precipitation or clogging are important challenges addressed during scale-up. Quality control tests are used to evaluate the scaled processes. Proper scale-up allows efficient transition from laboratory to commercial production of injectable drug products.
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.
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.
Modified resazurin microtiter assay for in vitro assessment of different anti...VRUSHALI KALEKAR
1) The document describes developing a microtiter plate-based assay using resazurin dye to test the susceptibility of pathogens to different antimicrobials.
2) Standardization experiments were conducted to determine the optimal bacterial concentration, dye concentration, and incubation times for common pathogens. A concentration of 106 cfu/ml bacteria and 0.5mM resazurin dye were found to give reliable results within 4-16 hours.
3) The developed assay was validated by testing 20 E. coli clinical isolates against various antibiotics and comparing results to standard disc diffusion testing. Most results matched between the two methods.
2.6.12. microbiological examination of non sterile products (total viable aer...Guide_Consulting
This document provides instructions for performing a total viable aerobic count test to quantify bacteria and fungi that may be present in non-sterile pharmaceutical products. The test involves preparing samples from the product, then examining the samples using membrane filtration or plate counting methods to determine the number of colony forming units per gram or milliliter of product. Specific steps are outlined for preparing water-soluble products, non-fatty insoluble products, fatty products, and transdermal patches. The document also provides details on conducting membrane filtration, pour plate, surface spread, and most probable number examination methods and calculating results.
This document summarizes quality control tests for various pharmaceutical products including parenterals, ophthalmic products, and surgical products. For parenterals, key tests discussed include sterility testing using direct transfer and membrane filtration methods, pyrogen testing using rabbit and LAL methods, leaker testing, and particulate matter testing. For ophthalmic products, tests outlined are for ocular toxicity/irritancy, preservative efficacy, particle size, sterility, and metal particles. Quality control of surgical products involves testing for acceptable materials and freedom from defects.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
Communicating effectively and consistently with students can help them feel at ease during their learning experience and provide the instructor with a communication trail to track the course's progress. This workshop will take you through constructing an engaging course container to facilitate effective communication.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
1. MAHATMA GANDHI VIDYAMANDIR’S
PHARMACY COLLEGE, PANCHAVATI, NASHIK 422003
Sub: Quality Control & Quality Assurance
A SEMINAR ON IPQC TEST OF
OPHTHALMIC PRODUCT
Presented By
Mr. Hemraj Dinkar Mahale
First Year M.Pharm.Sem I (2019 Pattern)
Roll No:- 40
Under The Guidance Of
Dr. K.V. Bhambar Sir
Department of pharmaceutical
Quality Assurance
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
1
2. MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
2
Vision:
To be a centre of professional excellence by contributing honestly to the pharmacist
moulding process.
Mission:
Impart high quality education to graduates
Contribute to all spheres to professional activities
Up hold human values and ethics
Nature them into globally competent professional
3. CONTENT:-
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
3
Ophthalmic Product
Types Of Ophthalmic Product
In Process Quality control test
4. What is OPHATHALMIC PRODUCT ……….?
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
4
Ophathalmic product is sterile,liquid,semi-solid product that may contain one or more active
pharmaceutical ingredient intended for application to the conjunctive,the conjunctival sac or the
eyelids
5. Types Of Ophthalmic Product
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
5
EYE DROP:- Eye drops are sterile aqueous or oily solutions or suspensions of drug for instilling
into conjunctiva sac with dropper
Used for anesthetic, anti – inflammatory , antiseptic , miotic , mydriatic
EYE OINTMENT :-Semisolid preparations based on oleaginous/ water washable bases packed
in collapsible tubes for easy transfer in to eye cavity by pressure.
LOTION :- These are sterile aqueous solutions intended for washing the eyes to remove irritant
or foreign body
6. In Process Quality control test for ophthalmic preparation
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
6
pH
Isotonicity
Uniformity of volume
Partical size
Sterility test
Clarity test
Leakage test
Presence of metal particles
7. 1) Ph :-
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
7
The pH of the ophthalmic pharmaceuticals is very important. Normal tears have a pH of about
7.4 and possess some buffer capacity.
In some cases pH may vary between 3.5 and 8.5. Some drugs, notably pilocarpine hydrochloride
and epinephrine bitartrate, are more acid and overtax the buffer capacity of the lacrimal fluid.
Ideally the pH of all the ophthalmic preparations should be same i.e. 7.4.
But practically it is not possible to maintain 7.4 pH and most drugs are chemically unstable at pH
levels approaching 7.4.
The final pH of the solution is often a compromise, because many ophthalmic drugs have limited
solubility and stability at the desired pH of 7.4.
Buffers or pH adjusting agents or vehicles can be added to adjust and stabilize the pH at a desired
level.
8. 2) Isotonicity :-
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
8
A solution is said to be isotonic when its effective osmole concentration is the same as that of
another solution.
In biology, the solutions on either side of a cell membrane are isotonic if the concentration of
solutes outside the cell is equal to the concentration of solutes inside the cell.
An amount equivalent to 0.9% sodium chloride (NaCl) is ideal for comfort and should be used
when possible.
The eye can tolerate tonicities within the equivalent range of 0.6 to 2% NaCl without discomfort.
A hypotonic ophthalmic solution will require the addition of a substance (tonicity adjusting
agent) to attain the proper tonicity range.
Sodium chloride, sodium nitrate, sodium sulfate, and dextrose are common neutral tonicity
adjustors.
9. 3) Uniformity of volume :-
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
9
This complies with the tests for contents of packaged dosage forms. Select a sample of 10 filled
containers, Clean and dry the outer of surfaces of the containers and weigh each container.
Specification for eye drops
TEST IP BP USP
Uniformity of volume 91-109%(labelled amount is
50gm or less)
95.5-104.5% ( labelled amount
is 50gm -100 gm )
NS NS
10. 4) Particle size :-
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
10
This test is applicable only to eye drops that are suspensions. Introduce a suitable volume of
sample into a counting cell or onto a microscope slide, as appropriate. Scan under a microscope
an area corresponding to 10 ug of the solid phase. Scan at least 50 representative fields.
Test IP BP USP
Particle
Size
NMT 20 particles
> 25 dimension,
NMT 10 Particle >
50 um dimension
and none > 100
um dimension (
for 10 um of solid
phase)
NMT 20 particles >
25 um dimension,
and NMT 2>50 ug
dimension
None > 90 um
dimension . (for 10
um of solid phase)
NS
11. 5) Sterility test :-
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The test must be carried out under aseptic conditions designed to avoid accidental
contamination of the product during testing.
The test is designed to reveal the presence of microorganisms in the samples used in the test .
• Two basic method for sterility testing:
I. direct inoculation method
II. membrane filtration method
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1) Direct inoculation method :-
a small volume of sample is removed aseptically from the sample unit and inoculated directly
into a suitable volume of growth medium before inculcation .
2) Membrane filtration method :-
Filtering of test sample using membrane filter Wash the membrane filter (wash to remove
inhibitory property) Transfer the membrane aseptically to the appropriate cutler media.
Detection of contamination used to two culture media:
a. Soyabean-casein digest media:- incubated at 20 to 25 C
b. Fluid thioglycollate medium:- incubated at 30 to 35 C
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Test IP BP USP
Sterility Test If no evidence of
microbial growth is found
in 14 days, the product to
be examined complies
with the test for sterility
If no evidence of
microbial growth is found
in 14 days, the product to
be examined complies
with the test for sterility
NS
14. 4.Clarity
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Ophthalmic preparations have to be free from foreign particles.
This is carried out by visual inspection under right light or with the aid of using Instruments
which include light scattering or video image projection
a. Visual inspection: - The preparation is tested under proper light, and viewed against a black and
white background with content set in movement with a swirling action
b. Instrumental method: -This technique makes use of the precept of light scattering, light
absorption, and electric resistance to gain particle count and size distribution-destruction of
product units An instrumental technique making use of video image projection detects
moving particles without destruction of product units-used for inline detection.
15. 6) leakage test :-
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This test is carried out for an ophthalmic ointment with seal
10 sealed containers are chosen and exterior surfaces of each tube should be clean and dry
They are horizontally located over absorbent blotting paper in an oven saved at temperature 60
± 3 for eight hours.
If leakage is determined the test is repeated with extra 20 tubes. The test passes if not greater
than l tube indicates leakage out of 30 tube
16. 7) Presence of metal particles:-
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Extrude, as completely as practicable, the contents of 10 tubes individually into
separate,clear,flat-bottom,60-mm Petri dishes that are free from scratches
Cover the dishes, and heat at 85 for 2 hours, increasing the temperature slightly if necessary to
ensure that a fully fluid state is obtained.
Taking precautions against disturbing the melted sample, allow each to cool to room temperature
and to solidify
Remove the covers, and invert each Petri dish on the stage of a suitable microscope adjusted to
furnish 30 times magnification and equipped with an eye-piece micrometer disk that has been
calibrated at the magnification being used
17. References
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1. THE INDIAN PHARMACOPΟΕΙΑ, GOVT. OF INDIA, MINISTRY OF HEALTH & FAMILY
WELFARE, "Monograph of parenteral", Volume 2, 2007, Pg no,39-42
2. USP. USP 36-NF 31, Ophthalmic Ointments 771. Rockville, MD: USP; 2013.
3. Gupta NV, Reddy GV. A Comparative study of quality control tests for eye preparations as per
IP, BP and USP. Int J Drug Dev Res. 2015;7(1):61-68.
Journal
4. Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;
12(3):348-360.
5. Gaudana R, Jwala j, Boddu SHS, Mitra AK. Recent perspectives in ocular drug delivery.
Pharm Res. 2009; 26(5):1197-1216.