This document provides an overview of in-process quality control (IPQC) tests for tablets and capsules during the manufacturing process. It discusses the importance and scope of IPQC, as well as general IPQC tests such as identity, quality, purity, and potency tests. Specific IPQC tests covered for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, content of active ingredients, weight variation, content uniformity, disintegration, dissolution, and moisture permeation are discussed. Various apparatus used to perform these tests are also described.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
Process Automation in Pharmaceutical Industry.pptxShalakaDhikale
With automation in place, pharmacies can now spend less on hiring and training employees while also reducing workplace manual errors. Automated systems operate with a better level of regulation and efficacy than people, whether it be when labeling, distributing medication, or performing any other daily task. Automation is the employment of tools and machinery in lieu of people to carry out physical and mental tasks during the production process.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
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)
Process Automation in Pharmaceutical Industry with specific reference to Man...vaidehishah25
PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MQA204T): Overview of Process Automation in Pharmaceutical Industry with specific reference to Manufacturing of Tablets and Coated Products, Improved Tablet Production
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Qualification of Friability Test Apparatus.pptxGNIPST
Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus.
share it with your friends also if they faced problem about this topic.
Thank you
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
Process Automation in Pharmaceutical Industry.pptxShalakaDhikale
With automation in place, pharmacies can now spend less on hiring and training employees while also reducing workplace manual errors. Automated systems operate with a better level of regulation and efficacy than people, whether it be when labeling, distributing medication, or performing any other daily task. Automation is the employment of tools and machinery in lieu of people to carry out physical and mental tasks during the production process.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
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)
Process Automation in Pharmaceutical Industry with specific reference to Man...vaidehishah25
PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MQA204T): Overview of Process Automation in Pharmaceutical Industry with specific reference to Manufacturing of Tablets and Coated Products, Improved Tablet Production
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
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Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
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Non sterile manufacturing process technology
1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
IN PROCESS-QUALITY CONTROL
TESTS FOR TABLET AND CAPSULE
4. What is Manufacturing?
1. Manufacturing is the making of goods by hand or by machine that
upon completion the business sells to a customer.
2. Items used in manufacture may be raw materials or component
parts of a larger product.
4
5. Manufacturing flowchart of non sterile product
Dispensing
Shifting
granulation
Drying and sieving
Lubrication
Compression
In process checking
Packging
Final product analysis and release
6. What is IPQC :
1. IPQC is concerned with providing accurate, specific, and definite
description of procedures to be employed from the receipt of raw
materials to the release of finished dosage forms.
2. IPQC procedures are generally quick, simple and rapid tests or
inspection that carried out at on going manufacturing.
3. In process quality control, IPQC tests are performed within the
production area.
6
7. 1.To detect the errors
2.To minimize the human errors.
3. Provides accurate, specific, and definite description of the
procedure to be employed.
4.To enforce the flow of manufacturing and packing
operations according to established routes and practice.
Why we need IPQC?
7
8. In process quality control are particularly important where
a process may be vary with time such as tablet weights,
fill volume, etc
Scope :
8
9. • Disintegration apparatus
• Dissolution apparatus
• Friability testing apparatus
• Bulk density apparatus
• Tablet hardness tester
• Infra- red moisture content measuring apparatus
• U.V Spectroscopy
Instrument used in IPQC department :
9
10. a) Identity tests:
These tests are qualitative chemical methods used to confirm the actual
presence of compound For example: colour formulation.
b) Quality tests:
These tests are the physical methods used to measure accurately the
characteristics properties of drug. For example: Absorbance
General IPQC tests:
10
11. c)Purity tests:
Purity tests are designed to estimate the levels of all known and significant
impurities and contaminants in the drug substance under evaluation.
For example clarity test for the solution.
d) Potency tests:
Potency tests are assays that estimate the quantity of active ingredient in
drug.
11
12. • Official Pharmacopeial Tests:
• Uniformity of weight
• Uniformity of Drug Content
• Disintegration test
• Dissolution test
• Non-Official (Non- Pharmacopeial )Tests:
• Hardness test
• Friability test
• Uniformity of Thickness
IPQC TESTS FOR TABLET :
12
13. 1. The volumetric fill of the die cavity determines the weight of the
compressed tablet.
2. The weight of the tablet is the quantity of the granulation that contains
the labeled amount of the therapeutic ingredient.
3. After the tablet machine in operation the weights of the tablets are routing
checked to ensure that proper tablet weights are made.
Weight variation :
13
14. 1. Randomly select 30 tablets. 10 of these assayed individually.
2. According to USP, content uniformity test is done for uncoated & film-
coated tablets containing less than 25% of the total weight and for all
sugar coated tablets.
3. The tablet pass the test if 9 of the 10 tablets must contain not less than
85% and not more than 115% of the labelled drug content and the 10th
tablet may not contain less than 75% and more than 125% of the labelled
content.
Content Uniformity Test:
14
15. 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.
Disintegration:
15
17. 1. The USP disintegration apparatus consist of 6 glass tubes that are 3
inches long, open at the top, and held against a 10-mesh screen at the
bottom end of the basket rack assembly.
2. Frequency of tablet is 28-32 cycles/min.
3. This test is done on 6 tablets and the test is passed when all the 6 tablets
disintegrate.
Liquid used in disintegration:
Water, simulated gastric fluid (PH=1.2) or simulated intestinal fluid(PH=7.5)
Disintegration test:
17
18. 1. Dissolution is performed to check the percentage release from the dosage
forms. i.e. Tablet.
2. Tablet breaks down into small particles which offers a greater surface area to
the dissolving media.
3. Disintegration test does not give assurance that particles will release drug in
solution at an appropriate rate, that’s why dissolution tests and its
specifications developed for all tablet products.
Dissolution test:
18
19. • IP apparatus
• Type 1 Paddle Apparatus
• Type 2 Basket Apparatus
• USP apparatus
• Apparatus1(rotating basket)
• Apparatus2(paddle assembly)
• Apparatus3(reciprocating cylinder)
• Apparatus4(flow-through cell)
• Apparatus5(paddle over disk)
• Apparatus6(cylinder)
• Apparatus7(reciprocating holder)
Dissolution test apparatus:
19
20. Apparatus‐1:
A single tablet is placed in a small wire mesh basket attached to the
bottom of the shaft connected to a variable speed motor.
The basket is immersed in a dissolution medium
contained in a 100 ml flask.
The flask is cylindrical with a hemispherical bottom.
The flask is maintained at 37±0.50C by a constant temperature bath.
20
21. Apparatus‐2
It is same as apparatus‐1, except the basket is replaced by a paddle.
The dosage form is allowed to sink to the bottom of the flask before
stirring.
For dissolution test U.S.P. specifies the dissolution test medium and
volume, type of apparatus to be used, rpm of the shaft, time limit of
the test and assay procedure for.
The test tolerance is expressed as a % of the labelled amount of drug
dissolved in the time limit.
21
22. Friabilator is the instrument which is used to detect the friability of the tablets .
Friability is the combined effects of shock and abrasions. So to resist shock and
abrasions friability test is done for the tablets.
In this a no. of tablets are put in the friabilator and revolves at 25rpm,
dropping the tablets a distance of six inches with each revolutions.
Friability is a property that is related to the hardness of the tablet.
Friability test:
22
23. 1. The amount of moisture present in the granule is called moisture content.
2. Generally the granules contain 2% moisture. It is required for the binding
of the powder or granules during compression in die cavity.
3. Percentages of moisture is calculated by using “moisture balance ”or
“IR Balance”.
4. The small amount of sample taken from oven to measure moisture content
& place in the moisture balance.
Moisture content:
23
24. 1. The test measures crushing strength property defined as the
compressional force applied diametrically to a tablet which just
fractures it.
2. Among a large number of measuring devices, the most favored
ones are Monsanto tester, Pfizer tester, and Strong Cobb
hardness tester.
3. All are manually used. So, strain rate depends on the operator.
4. using the hardness tester, measure the hardness for 10 tablets.
Tablet Hardness :
24
26. 1. The thickness of a tablet depends on the upper and lower
punches at the moment of compression.
2. Tablet thickness is an important QC test for tablet packaging.
3. Very thick tablet affects packaging either in blister or plastic
container.
4. The thickness of the tablet may be measured manually or by
automatic equipment.
Tablet Thickness:
26
28. Content of Active Ingredients
Weight variation
Content uniformity
Disintegration test
Dissolution test
Moisture permeation test
IPQC TEST FOR CAPSULE:
28
29. This test a sample of the contents is assayed as described in individual
monographs and calculates the amount of active ingredient in each
capsule.
According to IP the range for the content of active ingredient stated in
the monograph is based on the requirement that 20 capsules, or such other
number may be indicated in the monograph are used in the assay.
Content of Active Ingredients:
29
30. Weigh the emptied shell individually
Remove the contents of each capsule with the aid of a small brush
Weigh the 20 capsules individually
If not all of the capsule fall within the limits,
The individual weights should be within the limits of 90٪ and
110٪ of the average weight.
Weigh 20 capsule individually and determine the average weight.
Weight variation : 1)For hard capsules:
30
31. 2)For soft capsules:
Weigh the capsules individually then cut and open the capsules
Remove the contents by washing with the suitable solvent
Allow the solvents to evaporate from the shells at room temp.
Weigh the individual shells
Calculate the contents
31
32. Hard capsules containing 25 mg or more of the drug contents
should meet content uniformity requirements.
The requirement is met, if the acceptance value of 10 capsules is
less than or equal to 15%. If acceptance value is greater than 15%
or is about 25 % then, test the next 20 capsules and calculate the
acceptance value.
Assay 10 capsules individually and calculate the acceptance value.
Content uniformity:
32
33. Disintegration test:
The disintegration test determines the capsule disintegrate with a prescribed
time when placed in a liquid medium under the prescribed integral
conditions.
Method-
According to B.P. and which applies to both hard and soft capsules
1.introduce one capsule in each tube and suspend the apparatus in a beaker
containing 60ml water at 37°C,
- If hard capsule float on surface of water, the disc may be added.
33
34. Dissolution test:
The dissolution test is carried out using the dissolution apparatus official
in both U.S.P and I.P.
The capsule is placed in a basket, and the basket is immersed in the
dissolution medium and caused to rotate at a specified speed.
The dissolution medium is held in a covered 1000ml glass vessel and
maintained at 37 °C. ±0.5°C by means of a constant temperature suitable
water bath.
34
35. By measuring pre test & protest weights of pellet, amount can be calculated
Any change in color indicates absorption of moisture
Observe the dessicant pellet for color change
Expose the packaged unit to known relative humidity over a specified time.
The degree and rate of moisture penetration is determined by packaging the dosage unit
together with a colour revealing desiccant pellet
Moisture Permeation Test:
35
36. 1.Leon Lachman Herbert A. Lieberman, The Theory
and practice of industrial pharmacy, Special Indian
Edition:2009 page no:296-302
2.N.K Jain, Pharmaceutical Product Development
Second Edition page no:105
Reference :
36