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.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
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.
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.
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.
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 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.
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
The document discusses quality control of parenteral products. It introduces parenterals and describes that they must be sterile, pyrogen-free, clear and stable. It outlines various quality control tests performed on parenterals like leaker tests, pyrogen tests and sterility tests. Leaker tests include visual inspection, dye tests and bubble tests to check for leaks. Pyrogen tests are conducted using in-vivo rabbit tests and in-vitro LAL tests. Sterility testing aims to detect microorganisms using direct inoculation of samples in fluid thioglycolate medium or soybean casein digest medium followed by incubation.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
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.
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.
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.
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 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.
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
The document discusses quality control of parenteral products. It introduces parenterals and describes that they must be sterile, pyrogen-free, clear and stable. It outlines various quality control tests performed on parenterals like leaker tests, pyrogen tests and sterility tests. Leaker tests include visual inspection, dye tests and bubble tests to check for leaks. Pyrogen tests are conducted using in-vivo rabbit tests and in-vitro LAL tests. Sterility testing aims to detect microorganisms using direct inoculation of samples in fluid thioglycolate medium or soybean casein digest medium followed by incubation.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
This document summarizes various quality control tests conducted on parenterals. Key tests include:
- Content uniformity testing to ensure accurate dosing between units
- Leaker testing to identify improperly sealed ampoules
- Pyrogen testing using rabbits to detect fever-causing contaminants
- Bacterial endotoxin testing to quantify potential endotoxin contamination
- Sterility testing using membrane filtration or direct transfer methods to confirm absence of microbes.
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.
This document provides an evaluation of quality control tests performed on parenteral products. It describes in-process quality control tests such as conductivity measurement, volume filled, temperature monitoring, and pH measurement. It also describes finished product quality control tests including content uniformity testing, leaker testing, pyrogen testing using both LAL and rabbit methods, sterility testing, and particulate testing using light obscuration and microscopic methods. The document provides detailed procedures for each quality control test performed on parenteral products.
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.
Sterility test and modern microbiological methodsMohammed Fawzy
This document provides an overview of sterility testing and rapid microbiological methods. It discusses sterility testing, including definitions, common media used, methods for preparing different types of test products, incubation periods, growth promotion tests, and interpreting results. It also briefly introduces some rapid microbiological methods like ATP bioluminescence, colorimetric growth detection, and cytometry systems. The key purpose of sterility testing is to detect any viable microorganisms in pharmaceutical products or medical devices labeled as sterile.
To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
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.
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
Quality control tests for parenterals pptsuraj p rajan
This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
The document discusses quality control tests for parenterals. Parenterals are sterile products intended for injection or implantation into the body. They require higher care in preparation than oral or topical products and must be sterile, non-pyrogenic, and free of particles. Key quality control tests include: 1) content uniformity testing to ensure consistent active ingredient amounts, 2) package integrity testing to check for leaks, 3) clarity testing to detect particles, 4) pyrogen testing using the Limulus amebocyte lysate assay to detect endotoxins, and 5) sterility testing using membrane filtration or direct inoculation methods. These tests ensure parenterals meet strict quality standards for safety.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the quality control tests of parenteral as referred in the pharmacopoeia.
Thank you for reading. Hope it was of help to you.
UIPS,PU team
The document discusses in-process quality control (IPQC) and final product quality control (FPQC) tests for parenteral pharmaceuticals. It defines parenterals as sterile dosage forms intended for administration other than orally to directly enter systemic circulation. The types of parenterals are described based on volume and packaging. Important IPQC tests are outlined including conductivity, pH, temperature monitoring and volume filled verification. Key FPQC tests for parenterals involve sterility testing, pyrogen testing, clarity evaluation, leakage assessment, uniformity of content and weight tests, and extractable volume determination. Methods for each test are concisely explained.
The presentation describes evaluation of sterility of parenteral products. It contains principle, methods, media selection and result interpretation of sterility test. carried out for pharmaceutical sterile products.
This document discusses various methods for assessing the efficacy of disinfectants and sterilization processes, including physical, chemical, and biological indicators. The turbidimetric method uses turbidity measurements after a short incubation period to assess the ability of disinfectants and antibiotics to inhibit bacterial growth. Chemical indicators monitor sterilization processes by undergoing color changes in response to heat, steam, or radiation. Biological indicators use bacterial spores to validate the sterilization of equipment and facilities.
The document discusses various evaluation tests performed on parenteral products, including sterility testing, clarity testing, leakage testing, pyrogen testing, and assay. Sterility testing involves incubating samples in culture media to check for microbial growth. Clarity testing examines products for visible particles. Leakage testing checks for cracks in ampoules. Pyrogen testing involves injecting products into rabbits to monitor for fever responses. Assay is performed to quantify the active ingredient in the parenteral preparation according to pharmacopeia methods. Proper testing helps ensure parenteral products are free of contaminants and contain the correct amount of active pharmaceutical ingredient.
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.
Sterility testing is required for all products labeled as sterile to ensure they have been effectively sterilized. Tests are conducted using specific culture media and procedures to detect any viable bacteria, fungi, or yeasts. The USP outlines sterility testing methods for various pharmaceutical products and devices, including membrane filtration and direct inoculation. Interpretation of results involves incubating samples and checking for any microbial growth over time, with growth indicating test failure.
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
This document summarizes various quality control tests conducted on parenterals. Key tests include:
- Content uniformity testing to ensure accurate dosing between units
- Leaker testing to identify improperly sealed ampoules
- Pyrogen testing using rabbits to detect fever-causing contaminants
- Bacterial endotoxin testing to quantify potential endotoxin contamination
- Sterility testing using membrane filtration or direct transfer methods to confirm absence of microbes.
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.
This document provides an evaluation of quality control tests performed on parenteral products. It describes in-process quality control tests such as conductivity measurement, volume filled, temperature monitoring, and pH measurement. It also describes finished product quality control tests including content uniformity testing, leaker testing, pyrogen testing using both LAL and rabbit methods, sterility testing, and particulate testing using light obscuration and microscopic methods. The document provides detailed procedures for each quality control test performed on parenteral products.
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.
Sterility test and modern microbiological methodsMohammed Fawzy
This document provides an overview of sterility testing and rapid microbiological methods. It discusses sterility testing, including definitions, common media used, methods for preparing different types of test products, incubation periods, growth promotion tests, and interpreting results. It also briefly introduces some rapid microbiological methods like ATP bioluminescence, colorimetric growth detection, and cytometry systems. The key purpose of sterility testing is to detect any viable microorganisms in pharmaceutical products or medical devices labeled as sterile.
To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
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.
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
Quality control tests for parenterals pptsuraj p rajan
This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
The document discusses quality control tests for parenterals. Parenterals are sterile products intended for injection or implantation into the body. They require higher care in preparation than oral or topical products and must be sterile, non-pyrogenic, and free of particles. Key quality control tests include: 1) content uniformity testing to ensure consistent active ingredient amounts, 2) package integrity testing to check for leaks, 3) clarity testing to detect particles, 4) pyrogen testing using the Limulus amebocyte lysate assay to detect endotoxins, and 5) sterility testing using membrane filtration or direct inoculation methods. These tests ensure parenterals meet strict quality standards for safety.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the quality control tests of parenteral as referred in the pharmacopoeia.
Thank you for reading. Hope it was of help to you.
UIPS,PU team
The document discusses in-process quality control (IPQC) and final product quality control (FPQC) tests for parenteral pharmaceuticals. It defines parenterals as sterile dosage forms intended for administration other than orally to directly enter systemic circulation. The types of parenterals are described based on volume and packaging. Important IPQC tests are outlined including conductivity, pH, temperature monitoring and volume filled verification. Key FPQC tests for parenterals involve sterility testing, pyrogen testing, clarity evaluation, leakage assessment, uniformity of content and weight tests, and extractable volume determination. Methods for each test are concisely explained.
The presentation describes evaluation of sterility of parenteral products. It contains principle, methods, media selection and result interpretation of sterility test. carried out for pharmaceutical sterile products.
This document discusses various methods for assessing the efficacy of disinfectants and sterilization processes, including physical, chemical, and biological indicators. The turbidimetric method uses turbidity measurements after a short incubation period to assess the ability of disinfectants and antibiotics to inhibit bacterial growth. Chemical indicators monitor sterilization processes by undergoing color changes in response to heat, steam, or radiation. Biological indicators use bacterial spores to validate the sterilization of equipment and facilities.
The document discusses various evaluation tests performed on parenteral products, including sterility testing, clarity testing, leakage testing, pyrogen testing, and assay. Sterility testing involves incubating samples in culture media to check for microbial growth. Clarity testing examines products for visible particles. Leakage testing checks for cracks in ampoules. Pyrogen testing involves injecting products into rabbits to monitor for fever responses. Assay is performed to quantify the active ingredient in the parenteral preparation according to pharmacopeia methods. Proper testing helps ensure parenteral products are free of contaminants and contain the correct amount of active pharmaceutical ingredient.
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.
Sterility testing is required for all products labeled as sterile to ensure they have been effectively sterilized. Tests are conducted using specific culture media and procedures to detect any viable bacteria, fungi, or yeasts. The USP outlines sterility testing methods for various pharmaceutical products and devices, including membrane filtration and direct inoculation. Interpretation of results involves incubating samples and checking for any microbial growth over time, with growth indicating test failure.
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
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A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
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Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
1. IPQC FOR PARENTRALS
AND OPTHALMIC
PRODUCTS
Guided by:
Dr. (Mrs.)S. P. Mahaparale.
Presented by:
Ms. Sai Shrikant Bapat.
M.Pharm Quality Assurance
2. IPQC - In Process Quality Control
IPQC means controlling the procedures involved in manufacturing of dosage forms
starting from raw material purchase to dispatch of the quality product in ideal
packaging.
IPQC gives an assurance to the manufacturer that the finished pharmaceutical
product fulfills all the quality requirements.
IMPORTANCE:
To minimize human errors.
Provide accurate, specific and definite description of procedure to be employed.
Its planned system to identify materials, equipments processed and operations.
Inspection of raw material, equipment, environment, process, testing with respect
to specification, packing and so on.
3. STEPS INVOLVED IN IPQC-:
1) Identify types of formulations manufacturing or going to manufacture,
e.g. Parentrals, ointments.
2) Identify which are the critical steps in the manufacturing of product,
where it will be necessary to check certain parameters to confirm that
the process is in control.
3) Identify specification of parameters which will confirm parameters are
within control.
4) Define frequency of checking of parameters.
5) Create monitoring and control records for all IPQC process.
6) Keep provision for modification of process if required.
7) The entire process is described and explained to IPQC workers and
supervisors before implementing. Records of such IPQC training may be
kept.
4. IPQC FOR PARENTRALS AND OPTHALMICS
Leakage test
Sterility test
Pyrogen test
Clarity test
Content uniformity and weight
5. Leakage Test-:
It is employed to check pakage integrity.
Package integrity reflects its ability to keep the product in and to keep potential
contamination out.
It is because leakage occurs when a discontinuity exists in the wall of a package
that can allow the passage of gas under pressure or concentration differential
existing across the wall.
Visual inspection-:
It is easiest leak test to perform and use for evaluation of large volume parentrals.
To increase the sensitivity of method the visual inspection of the sample container
may be coupled with the application of vaccum to make leakage more readily
observable.
This method is simple and inexpensive.
6. Dye Bath Test –: For parentrals
1. The test container immersed in vaccum chamber consisting of 1%
methylene blue solution.
2. A vacuum of about 27” inches Hg is created for 15-30 mins.
3. This causes the solution to enter the container with defective sealing.
4. The vacuum is released and ampoules are observed.
5. If a leakage is present , solution in container appear blue in colour.
The test is qualitative, destructive and slow. It is used for
ampoules and vials.
This test is widely accepted in industry and is approved
in drug use.
7. 1) Select 10 tubes of the ointment with seals applied when specified.
2) Thoroughly clean and dry the exterior surfaces of each tube with an
absorbent cloth.
3) Place the tubes in horizontal position on a sheet of absorbent blotting
paper in an oven maintained at temperature of 60 for 8 hours.
4) No significant leakage occurs during or at the completion of test.
5)If leakage is observed from one, but more than one of the tubes repeat the
test with additional 20 tubes of ointments.
6)The requirement is met if no leakage is observed from the first 10 tubes
tested or if leakage is observed from not more than one of 30 tubes tested.
Leaker test -: For ophthalmic
8. Opthalmic Preparations
Opthalmic products are the sterile products meant to instillation in
to the eye in the space between eye lid and the eye ball.
These products must be sterile and are prepared under the same
condition and by the same methods as other parentral
preparations.
Opthalmic products includes-:
Eye drops
Eye lotions
Eye ointment
Eye suspension
Contact lens solution
9. Sterility Test-:
The test for sterility are intended for detecting the presence of viable
micro-organism in sterile preparation.
It is based on principle that if micro-organism are placed in a medium
that provide optimum condition of nutrition, moisture, pH, aeration,
temperature, they can grow and their presence will be indicated by
presence of turbidity in clear medium.
It is done by two methods-
1. Membrane filtration method
2. Direct inoculation method
10. Membrane Filtration Method –
Use membrane filters having a nominal pore size not greater than 0.4μm whose
effectiveness to retain microorganisms has been established.
Cellulose nitrate filters, are used for aqueous, oily, and weakly alcoholic solutions;
and cellulose acetate filters, are used for strongly alcoholic solutions.
Specially adapted filters may be needed for certain products (e.g., for antibiotics).
The technique described below assumes that membranes about 50 mm in diameter
will be used.
If filters of a different diameter are used, the volumes of the dilutions and the
washings should be adjusted accordingly. The filtration apparatus and membrane
are sterilized by appropriate means.
The apparatus is designed so that the solution to be examined can be introduced
and filtered under aseptic conditions: it permits the aseptic removal of the
membrane for transfer to the culture medium, or it is suitable for carrying out the
incubation after adding the medium to the apparatus itself.
11. After filtration the preparation membrane is cut into two halves. One halve is
transferred in to 100ml of culture medium meant for the growth of the bacteria
and incubated at 30 to 35°C for not less than 7 days. The another halve is
transferred to 100 ml of culture medium meant for fungi and incubated at 20 -
25 o C for not less than 7 days.
Detection of contamination used two culture media-:
A) Soyabean-Casein digest medium -: incubate at 20-25 degree C
B) Fluid thioglycollate medium -: incubated at 30- 35 degree
C on 7 days.
12. Direct Inoculation Method –
Although international pharmacopoeias recommend using standard membrane
filtration for sterility testing, there are certain products that are not filterable or
deformable.
These products are normally tested using direct inoculation.
In this method, the test sample is added directly into the required media, ensuring
that the amount of sample is below 10%.
To comply with your different direct inoculation method requirements, sterility
test media in various volumes, from 9mL tubes up to 75 mL bottles are available.
In this method an aliquot quantity of the material being tested is drawn
aseptically from the container and transferred to a vessel containing a measured
quantity of a suitable culture medium.
The culture is incubated at appropriate temperature for not less than 14 days.
The culture medium is observed at periodic intervals during the incubation period
and at the end to detect presence of any microbial growth.
13. Membrane Filtration Direct Inoculation
It requires the membrane filter unit. Does not require membrane filter
unit.
Sample is not directly inoculated into
media.
Samples are directly inoculated
into media.
Passes through a 0.45 mm
membrane filter
-
Product to be analyzed should be
aqueous solution, soluble solid, oil
or oily solutions, semisolids.
Product to be analyzed should be
oily liquids, semisolids,
14. Pyrogen test-:
Pyrogens are products of metabolism in microorganism gram –ve bacteria
produces most potent pyrogens.
When these pyrogens are introduced into a body they produce a mark response of
fever with body ache and vasoconstriction within onset of 1 hour. Basically these test
performed to detect presence of pyrogens in sterile parentral products.
LAL Test
Rabbit Test
15. Limulus Amebocyte Lysate (LAL) Test-
The LAL Assay is an in vitro assay used to detect the presence and
concentration of bacterial endotoxins in drugs and biological products.
This test is based upon the gelling property of an enzyme, the limulus
amebocyte lysate extracted from the horse shoe crab, limulus polyphormus.
The enzyme gels in the presence of bacterial endotoxin and the degree of
gelling is related to the amount of endotoxin present.
A no. of instrument is available for measuring the degree of gelling of
enzyme. The test can be used for quantifying the amount bacterial
endotoxin present and provide a better information regarding the quality of
a product than rabbit pyrogen test which is more of a qualitative test.
16. Rabbit Test-:
Preliminary Test (SHAM test)-
If animals are used for the first time in a pyrogen test or have not been used
during the two previous weeks, condition them one to three days before
testing the substance being examined, by injecting I.V. 10 mL of pyrogen-free
saline solution per kilogram of body weight.
Carry out the test in a room with no risk of disturbing or exciting the animals,
and a room temperature that is within 3 degrees of the area where the
animals are housed, or in which the animals have been maintained for at least
18 hours before the test.
Food and drink should be withheld from the animals overnight and until the
test is completed.
Record the temperature of the animals beginning at least 90 min. before
injection and for 3 hours following injection of the solution under
investigation.
Any animal showing a temp. In the main test, any change of 0.6 or greater
must be avoided.
17. Main Test-
Inject the solution under examination slowly into the marginal vein of the ear
of each rabbit over a period not exceeding 4 minutes, unless otherwise
prescribed in the monograph.
Record the temperature of each animal at half-hourly intervals for 3 hours
after the injection.
The difference between the “starting temperature” and the “maximum
temperature,” which is the greatest temperature a rabbit has ever been
measured at, is considered its response.
Interpretation of results -
If the sum of the responses of the group of three rabbits does not exceed
1.4°C and if the response of individual rabbits is less than 0.6°C, the
preparation under examination passes the test.
If it exceeds, repeat the test with five more rabbits.
18. Clarity Test-:
It is carried out to check the particulate matter in the sample.
It’s practically impossible that every unit of lost is perfectly free from visible
particulate matter.
There are 2 methods-
1) Visual inspection by naked eye
2) Instrumental method
USP limit for LVP-
Particle size Particle limit
10mm or larger/ml 50
25mm or larger/ml 5
19. Visual inspection by naked eyes-:
Each injectable is inspected visually against white and black backgrounds.
The white background aids in detection of dark coloured particles.
The light or reflective particles will appear against the black background.
Instrumentation method-:
This is also called As the particle count method.
Particle counting may be based on any on eof the following principles;
change in
• Electrical resistance
• Light absorption
• Light scattering
20. Metal particles in ophthalmic ointment-:
Extrude as completely as practicable the content of 10 tubes individually into
separate, clear, flat-bottom, 60 mm petridishes that are free from scratches.
Cover the dishes and heat at 85 degree C 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 petridish on the stage of suitable
microscope adjusted to furnish 30 times magnification and equipped with an
eye pieces mm disk that has been calibrated at the magnification being used.
Examine the entire bottom of petridish for metal particles.
Count number of metals particles that are 50um on larger in any dimension.
The requirements are met if total no. of particles in all 10 tubes does not
exceeds 50 an dif not more than 1 tube is found to contain more than 8 such
particles.
If these results are not obtained, repeat the test on 20 additional tubes.
21. Content Uniformity & Weight
Determine the content of the active ingredient of each of 10 containers taken at
random. The preparation under examination complies with the test if the
individual values thus obtained are all between 85 and 115 percent of the
average value.
The preparation under the examination fails to comply with the test if more than
one individual value is outside the limits 85 to 115 percent of the average value
or if any one individual value is outside the limits 75 to 125 percent of the
average value.
If one individual value is outside the limits 85 to 115 percent but within the limits
75 to 125 percent of the average value, repeat the determination using another
20 containers taken at random.
The preparation under examination complies with the test if in the total sample
of 30 containers not more than one individual value is outside the limits 85 to
115 percent and none is outside the limits 75 to 125 percent of the average
value.
22. Limits for uniformity of weight is given in Table –
Pharmaceutical
Formulation
Average Mass Percentage
Deviation (%)
Powders for
parenteral use
More than 40 mg 10
Powders for eye drops Less than 300mg 10
Powders for eye
lotions
300mg or more 7.5