The document discusses in-process quality control testing that is performed on hard and soft gelatin capsules during the manufacturing process, including physical tests like disintegration testing and weight variation testing, and chemical tests like dissolution testing, assay testing, and content uniformity testing to ensure the quality of capsules meets specifications. It provides details on the types of tests, acceptance criteria for tests, and equipment used to perform various quality control tests at different stages of the capsule manufacturing process.
These defects can cause serious injury and harm. When this occurs, you should speak with our product liability attorneys in Denver. You may have a viable claim to file a product liability lawsuit against the negligent manufacturer.Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, as may be required for tablets.Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
These defects can cause serious injury and harm. When this occurs, you should speak with our product liability attorneys in Denver. You may have a viable claim to file a product liability lawsuit against the negligent manufacturer.Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, as may be required for tablets.Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
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.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
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.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
Quality control test for capsule and finish product of capsule are
■ weight variation test
■ Dissolution test
■ Disintegration test
■ moisture permeation test
■ contents uniformity test
■ blooms gelatin strength .
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 cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
IPQC of Pharmaceutical Dosage Form at Pharmaceutical Industry mahbub tanim
This slides contents some details on In Process Quality Control (IPQC) of pharmaceutical dosage form (tablet, capsule, syrups, sterile etc.) at pharmaceuticals before sent them to Quality Control (QC) department.
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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In Process And Final Product Quality Control Test For Capsules
1. SMT R.D Gardi B.Pharmacy College Nyara ,Rajkot
Presented By- Akshita Dholakiya
B.Pharm
Guided By- Kajal Pradhan
Assistant professor
M.Pharm(pharmaceutics)
In Process And Final Product Quality Control
Test For Capsules
(Soft And Hard Gelatin)
3. Introduction
Definition: According to IP the In process quality
control is a process of monitoring critical variables
of manufacturing process to ensure a quality of the
final product.
• IQPC test are performed at regular intervals
(generally each 1hr later) during the manufacturing
process.
• These tests are vary from dosage form to dosage
form.
3
4. Why we perform In-Process Quality Control?
To optimize the technological procedure used in
manufacturing process.
To monitor, control and improve effectively the whole
applied operations at every stage of the finished
pharmaceutical products.
Inspection of raw material, equipment, environment,
process, testing with respect to specification, packing,
etc.
Quality and process control.
4
6. Hard gelatin capsule: It is a type of capsule
consist of dry powder,granules or very
small pellets. Also called as hardgel shells.
• It consist of two parts capsule body and
capsule cap.
Eg:Ampicillin capsule,omeprazole capsule.
Soft gelatin capsule: It consist of a gelatin
based shell surrounding a liquid or
semisolid fill. Also called as softgel shells.
Eg: vitamins And mineral capsules
6
7. IPQC Test
Physical Test
1) Disintegration test
2) Weight variation test
Chemical Test
1) Dissolution test
2) Assay
3) Content uniformity test
4) Content of Active Ingredients
5) Stability testing
6) Moisture permeation test
7
8. Chemical test
1.Dissolution test
8
• Dissolution testing measure the extent and rate of solution
formation from a dosage form, such as
tablet,capsule,ointment etc .
• The dissolution of a drug is important for its bioavailability
and therapeutic effectiveness.
Dissolution test apparatus by s.v
scientific technologies
9. stage Number of capsule tested Acceptance criteria
S1 6 Each unit is not less than Q+5%
S2 6 Average of 12 units (S1+S2) is equal to or
greater than Q and no unit is less than Q-15%
S3 12 average of 24 units(S1+S2+S3) is equal to or
greater than Q not more than 2 units are less
than Q-15% and no unit is less than Q-15%.
Acceptance criteria for dissolution test of capsule
9
10. • Identification : this test identifies the API in the pharmaceutical
capsule. This test should be able to identify the compounds of closely
related structure that are likely to be present.
• Assay:This test determines the strength or content of the API in the
pharmaceutical capsule and it s also called as content test
.
• Impurities: This test determines the presence of any component that
is not the API or excipients of pharmaceutical tablet. The process
impurities is the most common type of impurities. That are arises from
the new drug substance synthesis, degradation products of the API.
• Appearance: Appearance of capsule must be uniform. For detect of
any flaws in the integrity and appearance of the capsule, visual or
electronic inspection should be undertaken
10
11. • Content of Active Ingredients: For this test a sample of the contents is assayed as
described in individual monographs and calculates the amount of active ingredient in each
capsule.
20 capsules, or such other number as may be indicated in the monograph, are used in the
assay. In the circumstances where 20 capsules cannot be obtained, a smaller number, which
must not be less than 5
• Size and Shape: Hard capsules- made in a range of sizes, the standard industrial range of size
for capsule is from 000 (the largest, 1.40 ml) to 5 (the smallest, 0.13 ml) are commercially
available
Soft gel capsules-available in variety of shapes and size such as spherical (0.05–5 ml), ovoid
(0.05–7 ml), cylindrical (0.15– 25 ml), tubes (0.5–0 ml), pear (0.3–5 ml) etc
.
11
13. Content Uniformity Test
• Uniformity of content is a pharmaceutical analysis parameter for the quality
control of capsule
• Multiple capsules are selected at random and suitable analytical method is
applied to assay the individual content of active ingredient in each capsule
14
15. Stability testing
Stability testing of capsules is performed to determine the
physicochemical stability of the drug substance in the finished
drug product under specified package
In recommended storage conditions intrinsic stability of the
active drug molecule and the influence of environmental factors
(e.g., temperature, humidity, light), on formulation components,
and the container and closure system.
The test is performed to find out the integrity of capsule shell.
16
Marshall stability test apparatus
16. Test conditions Observation
80% RH at room temperature in an open container Capsule are observed periodically for 2 weeks, both
gross and subtle effects of the storage conditions are
noted and recorded. The control capsule should not
be affected except at the 80% RH station.
40°C in an open container.
40°C in a closed container(glass bottle with tight
screw-cap.)
Test conditions for accelerated stability tests for capsule dosage forms
17
17. Moisture permeation test
• This test is carried out to assure the suitability of containers for packaging of capsule .
• The degree and rate of moisture penetration of containers are determined by packaging the
dosage unit together with color revealing desiccant pellet.
18
Labthink W3/030 moisture permeation tester
18. Microbial contamination
The capsules are tested to ensure
lack of growth of bacteria and
mould by microbiological tests.
These tests are usually carried out
by incubation of the capsule
contents in a growth medium and
counting the colonies formed after
a predefined period of time.
Selection of the growth medium
and duration of the test, as well as
maintenance of aseptic conditions
during the testing, are critical to
successful assessment of microbial
contamination by this method.
19
19. Physical Test
• The disintegration test determines the ability of a capsule to break down into
smaller particles or granules disintegrate within prescribed time.
1) Disintegration Test
20
Disintegration apparatus
21. Weight variation test
• Weight variation test is also known as uniformity of weight, it is the official
quality control test which is performed to ensure that each tablet dosage form
has the accurate amount of drug.
• The test is conducted by weighing 20 tablets individually on an analytical
balance, computing the average weight, and comparing the individual weights of
the tablet to the average.
22
22. 23
Number of capsule
Average net weight of capsule Deviation(%)
Less than 300 mg0 mg
300mg and more
±10.0
±7.5
±15.0
Minimum 18
Maximum 2
Minimum 18
Maximum 2
±20.0
Standard limits of avg. weight of capsule according to I.P
23. Reference
• Lachman /Lieberman’s the Theory and Practice of industrial Pharmacy
Fourth Edition
• Indian pharmacopoeia eighth edtion (IP 2018)
• British pharmacopoeia(BP2019)
• PV publication industrial pharmacy-1 by Dr Shalini sharma.
• https://pharmapathway.com/process-quality-control-review/
• https://www.researchgate.net
• https://en.wikipedia.org
• Images source - google.com 24