This document discusses in process quality control (IPQC) and finished product quality control (FPQC) tests for tablets. It begins with introducing the concepts of quality, quality control, IPQC and FPQC. It then lists and describes common tests conducted for tablets, including tests for size and shape, colour and odour, hardness, friability, content uniformity and dissolution. Standard acceptance criteria for many of the tests are also provided. The document emphasizes that IPQC and FPQC are important to control quality, identify errors, and ensure product specifications are met.
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
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)
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
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)
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
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 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
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.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
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 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
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.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
The role of dissolution in the demonstration of bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Environmental studies deals with every aspect that affect the living organism.
It is essentially a multidisciplinary approach that brings about an appreciation of our nature world and human impact its integrity.
Environment is a aggregate of physical, chemical, biological and social component on earth which are capable of causing direct or indirect effect in a short or long term on living or non living things and their interactions and activity.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey
IPQC and FPQC for tablets
1. IPQC AND FPQC FORTABLETS
PREPARED BY:SAKSHI ASHOK GAIKWAD
ROLL NO: QA 07
FIRST YEAR M.PHARM
(QUALITY ASSURANCE)
SEMESTER 1
GUIDED BY: PROF. MUKESH PATIL.
SHRI. D. D.VISPUTE COLLEGE OF PHARMACY
AND RESEARCH CENTRE, PANVEL.
05/05/2021 1
2. CONTENTS
1. Introduction
2. In process quality control
3. Finish product quality control
4. Objectives
5. IPQC & FPQC test:
a) size and shape
b) colour and odour
c) Unique identification marking
d) thickness
e) Hardness
f) Friability
g) Weight variation
h) Content uniformity
i) Content of active ingredients
j) Disintegration test
k) Dissolution test
6. Conclusion
7. References
05/05/2021 2
3. 05/05/2021 3
QUALITY
Quality is a broad term which includes suitability of drugs and
products for their utilization which is decided by their efficiency
and safety, according to label claim, or as promoted or
publicized, their conformity to specifications about identity, purity
and other characteristics.
The quality of any product must be built during plant
construction, product research and development, purchasing of
materials, production, testing, inspection, labelling, storage and
distribution.
4. QUALITY CONTROL
■ The International Standard of Organization (ISO) definition states
that quality control is “the operational techniques and activities that
are used to fulfil requirements for quality.
■ It is a part of GMP
■ To eliminate errors and production of end product of given
specifications
05/05/2021 4
IN PROCESS QUALITY CONTROL (IPQC)
FINISHED PRODUCT QUALITY CONTROL (FPQC)
5. IN PROCESS QUALITY CONTROL (IPQC)
05/05/2021 5
The function of in-process quality controls is to monitor and if
necessary, adaptation of the manufacturing process in order to
comply with the specification
Be carried out before the manufacturing process is completed
Physical parameters and its quality attributes
Involve control of equipment and environment too
6. FINISHED PRODUCT QUALITY CONTROL (FPQC)
■ These are the test carried out after completion of product
manufacturing process
■ Qualitative and quantitative analysis of product
■ Determines the test procedures and acceptance limit
■ The product must comply with the acceptance limit for the approval of
complete batch manufactured.
05/05/2021 6
7. OBJECTIVES
■ Monitor all the features of product that contributes to the
quality
■ Prevent errors
■ Provide product as per specifications
■ Identify or detect any error
■ Rectify error
05/05/2021 7
8. IPQC and FPQC tests:
■ Particle size
■ Loss on drying
■ Colour
■ Compactness
■ Integrity
■ Temperature
■ Assay
■ Uniformity of content
■ Uniformity of mass
■ Weight variation
■ Friability test
■ Content of active
ingredients
■ Hardness test
■ Disintegration test
■ Dissolution test
■ Moisture content
■ Hardness
05/05/2021 8
9. SIZE AND SHAPE
according to need of the dose requirement and can be dimensionally describe,
monitored and controlled.
It is determined by the tooling during the compression processes
05/05/2021 9
10. COLOUR AND ODOUR
To mask the original characteristics for consumer acceptance
Uniformity
The taste is the important factor when is comes to chewable tablets while odor
in vitamins.
05/05/2021 10
11. UNIQUE IDENTIFICATION MARKING
Embossing, engraving or printing
Mainly for Identification purpose
Eg. Company name or product code or specific symbol on it
05/05/2021 11
12. THICKNESS
Dimensional variable related to the process
A single tablet dimensions are measured and this is done for the whole batch
It should in between -5 and +5 mm or standard dimensions
05/05/2021 12
VERNIER CALIPER
13. HARDNESS
The resistance of the tablet to chipping, abrasion, or breakage under conditions of
storage, transportation, and handling, before usage, depends on its hardness.
Hardness is affected by- compression of tablet and compressive force
-method of granulation.
Limits -
5 kilograms minimum and 8 kilograms maximum.
05/05/2021 13
Monsanto type hardness tester
14. FRIABILITY
This property is related to hardness of tablets.
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
Roche friabilator
05/05/2021 14
15. WEIGHT VARIATION
Difference in weight of tablets in a batch is measured
Average Weight (mg) Percentage Deviation (%)
130 or Less 10
130 – 324 7.5
More than 324 5
The above table is as per USP
CONTENT UNIFORMITY
This helps to understand the consistency of active pharmaceutical ingredients in
the tablets
This gives potential for efficacy of tablet in a batch and from batch to batch
05/05/2021 15
16. CONTENT OF ACTIVE INGREDIENTS
The content of active ingredients can be determine by the assay procedure
Weight of Active Ingredients in Each
Tablet
Subtract from Lower Limit for Samples
of
Add to the Upper Limit for Samples of
15 10 5 15 10 5
0.12 g or less 0.2 0.7 1.6 0.3 0.8 1.8
More than 0.12 g But less than 0.3 g 0.2 0.5 1.2 0.3 0.6 1.5
0.3 g or more 0.1 0.2 0.2 0.2 0.4 1.0
The above table is as per I.P. limits
05/05/2021 16
17. DISINTEGRATION TEST
The disintegration test is used to show how quickly the tablet breaks down into
smaller particles, allowing for a greater surface area and availability of the drug
when taken by a patient
DISINTEGRATION TEST APPARATUS
05/05/2021 17
18. Categories of Tablets Disintegration Time (min)
Uncoated tablets 15
Coated tablets 60
Effervescent tablets 5
Soluble tablets 3
Dispersible tablets 3
Orodispersible tablets 3
Gastro-resistant tablets 60
Oral lyophilizates 3
Categories of Tablets Disintegration Time (min)
Uncoated tablets 15
Coated tablets 60
Enteric coated tablets 60
Film coated tablets 30
Effervescent tablets 5
soluble tablets 3
dispersible tablets 3
BP limits for disintegration times of tablets IP limits for disintegration times of tablets
05/05/2021 18
19. DISSOLUTION TEST
Dissolution testing measures the extent and rate of solution formation from a
dosage form
The dissolution of a drug is important for its bioavailability and therapeutic
effectiveness.
In dissolution solid mass is transfer in liquid medium that is it is aqueous solubility
dependent process
More the aqueous solubility more is the dissolution rate
Dissolution test is based on following processes-
1. wetting
2. Solubility
3. Swelling
4. Diffusion
DISSOLUTIONTEST APPARATUS
05/05/2021 19
20. USP apparatus Description of the apparatus Rotation speed Dosage forms to be tested
I. basket 50- 120rpm Immediate release tablets
Delayed release tablets
Extended release tablets
II Paddle 25-50 rpm Immediate release tablets
Delayed release tablets
Extended release tablets
III Reciprocating cylinder 635 dpm Immediate release tablets
Extended release tablets
IV flow-through cell N/A Extended release tablets
Poorly soluble drug
V paddle over disk 25-50 rpm Transdermal
VI cylinder N/A Transdermal
VII reciprocating holder 30 rpm Extended release tablets
ABOVE TABLE IS AS PER USP
05/05/2021 20
21. STAGE NO. OF TABLETS ACCEPTANCE CRITERIA
S1 6 Each unit is not 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
Q25%
ACCEPTANCE CRITERIA FOR DISSOLUTION OF TEST TABLETS
05/05/2021 21
22. CONCLUSION
05/05/2021 22
Standard operating procedures must be established and followed to compare
the quality of the product formed.
All the materials should be tested during and after the manufacturing process
to control the quality of the product.
In process and finished product test are carried out so as we get early
warning of any error in the product and can be rectified soon
23. REFERANCES:
Comparative study of in-process and finished products quality control test for tablet and capsules
according to pharmacopoeias: Asian Journal of Pharmaceutical Research and Development. 2018;
6(3): 60-68
L Lachman, HA Lieberman, JL Kanig. The Theory and Practice of Industrial Pharmacy, 3rd Edition,
Lea & Febiger, Philadelphia, 1986, 296-300
Unites States Pharmacopoeia Convention. United States Pharmacopoeia 31-National Formulary 33,
Stationery Office, USA, 2010.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia, volume 1, Indian Pharmacopoeia
Commission, Ghaziabad, 2007
In-Process and Finished Products Quality Control Tests for Sterile and Non Sterile Dosage Form: Int.
J. Pharm. Sci. Rev. Res., 45(1), July - August 2017; Article No. 40, Pages: 206-214
Sagar Kishor Savale. / Asian Journal of Phytomedicine and Clinical Research. 6(1), 2018, 44-54.
05/05/2021 23