The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
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.
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 Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
IPQC is concerned with providing accurate, specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
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)
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
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.
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 Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
IPQC is concerned with providing accurate, specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
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)
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
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 & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
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 & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
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.
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 (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. In a pharmaceutical organization a quality control deals with testing, sampling, specification, and documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. There are several types of hormonal product in different dosage form. These hormonal product quality control and maintaining lies on their specific dosage system. The achievement of these test for hormonal product provides a significant challenge to ingenuity and creativity of hormonal scientist and technologist.
INDUSTRIAL TRAINING REPORT (B-pharmacy ) Zentiva pharmaceutical industry PrakashKumar721
Location:- GIDC Estate Ankleswar
393002, Dist. Bharuch ,Gujrat India
Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4,700 people and a network of production sites - including flagship sites in Prague, Bucharest and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better supportpeople’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators and governments to provide the everyday solutions that we all depend on.
About Zentiva’s Ankleshwar site
Established in 1987, the Ankleshwar manufacturing site has a chemistry and biotechnology development center, and manufactures both intermediates and pharmaceutical formulations. A large producer of tablets, the Ankleshwar site manufactures more than 6 billion tablets annually.
Mission &Values:-
Zentiva is a leading developer and supplier of high-quality affordable prescription medicines and consumer brands. As Zentiva grows more people get the medicine they need. Our business is built on trust and responsibility with the patient at the heart of everything we do. Zentiva has established 6 shared SuperpowerZ which frame the values and behaviours we expect of our team and how we will build a healthy business that we can all be proud of.
TABLET-SECTION
Tablet:-
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life.
Advantage
• Production aspect
Large scale production at lowest cost
Easiest and cheapest to package and ship
High stability
• User aspect (doctor, pharmacist, patient)
Easy to handling.
Lightest and most compact.
Greatest dose precision & least content variability.
Coating can mark unpleasant tastes & improve pt. acceptability.
PHARMACEUTICAL PRODUCT BY ZENTIVA PHARMACEUTICAL PVT.LTD:-
1. Avil -25 mg
2. Trental-400
3. Paracetamol-500mg
4. Ramilich-( 5, 25mg)
5. Ramipril-25mg
6. Zuglimate-500mg
7. Clopidogrel-75mg
8. Metformin-100mg
QUALITY CONTROL AND QUALITY ASSUARANCE
Quality control is the part of GMP that deals with sampling, specification, and testing, as well as organisation, documentation, and release procedures to ensure that necessary and
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS
Ipqc test of tablet
1. In process & finished products quality control
test for pharmaceuticals
Arpit rajaram suralkar
M pharm quality assuarance
First year
2. Why IPQC Important
• To Monitor and improve effectively the whole
applied process at the every stage of the
finished pharmaceutical products by according
to Standard Operating Procedures (SOPs).
• The importance of IPQC to carry out complete
testing before, after and during the
manufacturing process is completed for the
Products.
3. INTRODUCTION
• All Pharmaceutical Industry aims to make products with good
quality products so this can be done by allowing In- Process
Quality Control (IPQC) Approaches.
• The importance of IPQC to carry out complete testing before,
after and during the manufacturing process is completed for
the Products
4. DEFINATION
• IPQC is concerned with providing accurate, specific and definite description of the
procedures to be employed from the receipt of raw materials to the release of the
finished dosage form.
• Quality is not an accident this is the result of intelligent effort.
• IPQC is varies from dosage form to dosage
form.
• IPQC tests are performed at regular intervals
(generally each 1 hr later) during the
manufacturing process
5. OBJECTIVES
• Inspection of raw material, equipment, environment, process, testing with respect
to specification, packing and so on.
• To monitor control and improve effectively the whole applied operations at the
every stage of the finished pharmaceutical products.
• To optimize the whole applied technological procedure.
6. IPQC Involve
• Biological and microbiological test
• Physical and chemical test:
Identity test
Quality test
Purity test
Potency test
7. Physical and chemical test:
• Identity Test- These tests are qualitative chemical
method used to confirm the actual presence of
compound. E.g. color formation, precipitation
• Quality test– These tests are physical method used to
measure accurate the characteristics properties of
drug. e.g.- absorbance, refractive index.
• Purity test- It is deigns to estimate the level of all
known and significant impurities and contamination in
the drug substances. E.g. test for clarity of solution,
acidity/alkalinity.
• Potency test- these tests always estimate the quality of
an active ingredient in drug.
8. Biological and microbiological test
• It involves the animals preparation isolated by living tissues.
• Biological test of drug can be qualitative or quantitative in
nature.
It included macro and micro biological ways and test for
safety,
toxicity,
pyrogenicity,
sterility,
antiseptic activities and
antimicrobial preservative effectiveness test.
9. In Process Checks Shall Includes Following
Process Controls
• Measured values obtained from the room environment like Temperature, Humidity
• Periodic check of control samples.
• Verification of yield at various stages of manufacturing process
• Product attributes Like Weight, Hardness
• Online review of batch record at every stage of process.
• Check vendor while goods are received and it should be according to approved
vendor.
• Checking of sieve/filter integrity
• Time limits at all stages of process.
• Checking and verification of material used as Material Name, Material Code,
Control No. or A.R. No.
• Equipment/instrument: Calibration, verification and checking of the status labels
• Checking of the status labels on the area and process containers
• Cleanliness of the area and line clearance
10. IPQC Before, After &During The Manufacturing
• At Sampling Stage : Planning of sampling should be done as
per the Standard Operating Procedures (SOP)s which
describes the sampling methods. Sufficient quantity of
samples should be collected for Analysis.
• At Manufacturing Stage : Weighing or measuring of active
pharmaceutical ingredients, excipients, diluents or vehicle
should be done under the suitable conditions which do not
affect their conformity of use. Appropriate and calibrated
equipment / instrument should be used for the above
purpose
• In Process Test Stage: In-process tests should be
performed on the sampled material. The quality control
dept. will be responsible for the testing. Samples are tested
by quality control personnel to verify conformance with
specifications within the acceptable limits
11. IPQC & FPQC For Tablets
• Size and Shape : The size and shape of the tablet can be
dimensionally described monitored and controlled. It is
determined by the tooling during the compression process
• Color and Odor : Many pharmaceutical tablets use color as
a vital means of rapid identification and consumer
acceptance. But it must be uniform within a single tablet,
from tablet to tablet and from lot to lot. The presence of an
odor in a batch of tablets could indicate a stability problem
e.g. the characteristic odor of acetic acid in degrading
aspirin tablets or could be characteristic of the drugs e.g.
vitamins have a characteristic odor. Taste is important in
consumer acceptance of chewable tablets.
12. Thickness :The thickness of a tablet is the only dimensional variable related to the process.
Thickness of individual tablets may be measured by a micrometer. Other techniques
involve placing 5 or 10 tablets in a holding tray, where their total thickness may be
measured by a sliding caliper scale. Tablet thickness should be controlled within a ± 5 %
variation of a standard. Thickness must be controlled to facilitate packaging. It is expressed
in mm.
Unique Identification Markings : Pharmaceutical companies often use some type of
unique markings on tablets in addition to color, for rapid identification of their product
these markings utilize some form of embossing, engraving or printing of the company
name or symbol or a product code.
Assay : In a tablet an active ingredient is present which is called API. So to prepare the
tablet assay has to be done by using suitable analytical method to produce good finished
product
Moisture Content of Granules : Granules should possess sufficient strength to withstand
normal handling and mixing processes without breaking down and producing large
amounts of fine powder. On the other hand, some size reduction during compaction into
tablets is desirable to expose the areas of clean surface necessary for optimum bonding
to take place so moisture content is the very important factor for producing good
pharmaceutical product
13. Uniformity of Content :
active substance(s) of 10 tablets taken at random. A physically sound
tablet may not produce the desired effects. To evaluate a tablet potential
for efficacy, the amount of drug per tablet needs to be monitored from
tablet to tablet and batch to batch
• For this test according to BP using a suitable analytical method, determine
the individual contents of
• The tablet complies with the test according to BP, if each individual
content is between 85 percent and 115 percent of the average content.
• The tablet fails to comply with the test if more than one individual content
is outside these limits or if one individual content is outside the limits of
75 percent to 125 percent of the average content
• If one individual content is outside the limits of 85 percent to 115 percent,
but within the limits of 75 percent to 125 percent, determine the
individual contents of another 20 tablets taken at random.
• The tablet complies with the test if not more than one of the individual
contents of the 30 tablets is outside 85 percent to 115 percent of the
average content and none is outside the limits of 75 percent to 125
percent of the average content.
14. Uniformity of Mass
This test is applicable for uncoated and film coated tablets.
For this test according to BP weigh individually 20 tablets
taken at random and determine the average mass. As per BP
the tablet complies with the test if not more than 2 of the
individual masses deviate from the average mass by more
than the percentage deviation as shown in Table 1 and none
deviates by more than twice that percentage.
Average Mass (mg) Percentage Deviation(%)
80 or Less 10
More than 80 and less than
250
7.5
250 or more 5
15. Weight Variation Test :
• According to the USP weight variation test is run by weighting 20 tablets
individually calculating the average weights and comparing the individual
tablet weights to the average
• The value of weight variation test is expressed in percentage. The
following formula is used.
• Weight Variation = (Iw – Aw)/Aw 100%
• where, Iw = Individual weight of tablet
Aw = Average weight of tablet.
• As per USP the tablet complies with the test if not more than 2 of the
individual masses deviate from the average mass by more than the
percentage deviation as shown in Table 2 and none deviates by more than
twice that percentage.
Average weight (mg) Percentage deviation (%)
130 or less 10
130 - 324 7.5
More than 324 5
16. Hardness Test
• For this test one of the earliest testers was Ketan tablet hardness tester,
which is a type of the Monsanto hardness tester to evaluate tablet
hardness tester
• The tester consists of a barrel containing a compressible spring held
between two plungers. The lower plunger is placed in contact with the
tablet and zero reading is taken.
• The upper plunger is then forced against a spring by turning a threaded
bolt until the tablet fractures
• As the spring is compressed, a pointer rides along a gauge in the barrel to
indicate the force. The force of fracture is recorded in kilogram
17. Friability Test
• Friability of a tablet can determine in laboratory by Roche friabilator.
• For this test twenty tablets are weighed and placed in the friabilator and then
operated at 25 rpm for 4 minutes. The tablets are then dedusted and weighed.
• The difference in the two weights is used to calculate friability and the value of
friability is expressed in percentage.
• It is determined by the following formula.
• Friability = (Iw – Fw)/Iw *100%
• where, Iw = Total Initial weight of tablets; Fw = Total final weight of tablets.
• As stated by USP if conventional compressed tablets that loss less than 0.5 % to 1
% (after 100 revolutions) of their weight are generally considered acceptable
18. Disintegration Test
• 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.
• To test for disintegration time, one tablet is placed in each tube and the basket
rack is positioned in specified medium at 37 ± 2 °C such that tablet remains 2.5 cm
below the surface of the liquid on their upward movement and descend not closer
than 2.5 cm from the bottom of the beaker.
• A standard motor driven device is used to move the basket assembly containing
the tablets up and down through distance of 5 to 6 cm at a frequency of 28 to 32
cycles per minute.
• Perforated plastic discs may also be used in the test.
• These are placed on the top of tablets and impart an abrasive action to the tablets.
• The discs may or may not be meaningful or impart more sensitivity to the test, but
they are useful for tablets that float. Operate the apparatus for the specified time
(15 minutes for uncoated tablet unless otherwise justified and authorized)
19. • The tablet complies with the test, if the tablets disintegrate, and all particles pass
through the 10-mesh screen in the time specified
• If any residue remains, it must have a soft mass with no palpably firm core.
• The tablet complies with the test according to USP, if all of the tablets have
disintegrated completely.
• If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional
tablets.
• The requirement is met if not less than 16 of the total of 18 tablets tested are
disintegrated
• The BP and IP limits for disintegration times of tablets are given in Table 4 and
Table 5 respectively
Categories of tablets Disintegration time (min)
Uncoated tablets 15
Coated tablet 60
Enteric coated tablet 60
Film coated tablets 13
Effervescent tablets 5
soluble tablets 3
Dispersible tablets 3
20. Dissolution Test
• Temperature inside the vessel at 37 ± 0.5 °C during the test and
keeping the bath fluid in constant, smooth motion
• Place 1 tablet in the apparatus, taking care to exclude air bubbles
from the surface of the tablet.
• Operate the apparatus at the specified rate
• Within the time interval specified, or at each of the times stated,
withdraw a specimen and replace with equal volumes of fresh
dissolution medium at 37 °C
• Verify the temperature of the medium at suitable times
• Perform the analysis using a suitable assay method as directed in
the individual monograph. Repeat the test with additional tablets.
• Unless otherwise specified in the individual monograph, according
to BP, USP, PhEur, JP the requirements are met if the quantities of
active ingredient dissolved from the tablets tested conform to the
following acceptance criteria.
21. Stage No of tablet tested Acceptance Criteria
S1 6 Each unit is not less than Q
S2 12 Average of 12 units (S1+S2)
is equal to or greater than Q
and no unit is less than Q-
15%
S3 18 Average of 24 unit 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- 25%