The document discusses the development of monographs for the Indian Pharmacopoeia. It outlines the Indian Pharmacopoeia Commission's vision of promoting high drug quality standards for medicines used in India. It describes the objectives in creating monographs that reflect India's pharmaceutical industry capabilities while safeguarding smaller manufacturers. The document provides guidance on the formats, contents and quality standards considered for monographs in different categories like active pharmaceutical ingredients, excipients, dosage forms and other drug products.
In ancient India the sources of drugs were of vegetable, animal and mineral origin.(Ayurveda).They were prepared empirically by few experienced persons. Knowledge of that medical system was usually kept secret within a family (Folkore).There were no scientific methods of standardization of drugs.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
In ancient India the sources of drugs were of vegetable, animal and mineral origin.(Ayurveda).They were prepared empirically by few experienced persons. Knowledge of that medical system was usually kept secret within a family (Folkore).There were no scientific methods of standardization of drugs.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
The 'Hamamelis cultivar names checklist 2014' assembles all officially registrated cultivar names of which hazels, Hamamelis. The author is Abraham Rammeloo, curator of Arboretum Kalmthout in Belgium. Arboretum Kalmthout is part of a world-wide network of International Cultivar Registration Authorities (ICRA) which play a vital role in promoting uniformity, accuracy and stability in the naming of cultivated plants. This checklist is compiled with the help of Chris Lane (UK), Wim van der Werf (NL), Tim Brotzman (USA) and Holger Konrad (DE).
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
The 'Hamamelis cultivar names checklist 2014' assembles all officially registrated cultivar names of which hazels, Hamamelis. The author is Abraham Rammeloo, curator of Arboretum Kalmthout in Belgium. Arboretum Kalmthout is part of a world-wide network of International Cultivar Registration Authorities (ICRA) which play a vital role in promoting uniformity, accuracy and stability in the naming of cultivated plants. This checklist is compiled with the help of Chris Lane (UK), Wim van der Werf (NL), Tim Brotzman (USA) and Holger Konrad (DE).
Pharmacopoeia: the word derives from the ancient Greek word pharmakon means drug & poeia- to make.
It is a legally binding collection, prepared by a national or regional authority& contains list of medicinal substances, crude drug & formulas for making preparation from them.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 5 has been released with
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of Downing Labs
- 483 of Impax Laboratories
FDA Recall letter observations
- Unique Pharmaceuticals Ltd
Warning Letters
- Pharmacy Creations, NJ
- Trifarma S.p.A., Italy
- Zhejiang Jiuzhou Pharmaceutical Co., China
EMA Non-Compliance Reports
- WOCKHARDT LIMITED, India
- SIMS Società Italiana Medicinali Scandicci srl, Italy
- SCM PHARMA LIMITED, UK
Regulations of the Month
§ 211.167 Special testing requirements
§ 211.170 Reserve Samples
§ 211.176 Penicillin contamination
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Following are the list of attributes to be followed;
1.0 Objective:
The purpose of the study is to develop analytical method for determination of Assay & Related substances in new formulation product by HPLC using UV-Visible detector.
2.0 Introduction:
This document will help analyst to develop robust Analytical method for routine testing.
3.0 Scope:
This guideline will provide information about analytical method development to be carried out as per ICH Guidelines.
4.0 Physico-Chemical details of API:
Following items to be checked viz;
IUPAC name, Molecular formula, Chemical structure, Molecular weight, Solubility, Appearance, Melting Point, pH solubility, pKa, LogP, BCS Classification, Polymorphism, Isomerism, Density, Hygroscopicity, Impurities listed as per process either in DMF or official monograph
Method Development and Validation for Estimation of Oral Hypoglycaemic Drug D...ijtsrd
HPLC is a chromatographic technique employed in active compound chemistry and biochemistry to separate a mixture and substances with the goal of identifying, measuring, and purifying the different components of the mixture. Its a much better variety of column and traditional chromatography. The objective of the research work is to develop and validate a simple and accurate reverse phase chromatographic method to estimate amount of drug in dosage form. The developed method successfully can be applied to estimate the amount of Dapagliflozin in tablet dosage form. After oral administration of dapagliflozin, the maximum plasma concentration Concentration max under two hours. High performance liquid chromatographic system was alleviated according to the chromatographic settings. After attaining the steady base line, to verify the system suitability, a single 40 µg ml of standard solution proportional to 100 test concentration of dapagliflozin was injected into the HPLC system. The gradient mobile phase flow rate programming assisted in optimising the lengthy run duration and resolution of sample analysis, making the approach more cost effective and quick. Validation of the developed and optimized HPLC method was carried out according to ICH guidelines with respect to parameters such as linearity, specificity, precision and accuracy. Junaid Ahmed | Himanchal Sharma | Shiva Teotia "Method Development and Validation for Estimation of Oral Hypoglycaemic Drug Dapagliflozinina Tablet Dosage form by the Employment of Rp-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46395.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46395/method-development-and-validation-for-estimation-of-oral-hypoglycaemic-drug-dapagliflozinina-tablet-dosage-form-by-the-employment-of-rphplc/junaid-ahmed
Handling of Refernce Standards_Dr.A.Amsavel Dr. Amsavel A
Definition
Requirements
Guidelines
Pharmacopiea
Types of Reference Standards
SOP for handling of Reference Standards
Qualification of Secondary Standards
Assigning Potency, Storage and Use
Documents & Records
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
High Performance Thin Layer ChromatographyPUNEET NIRMAL
HPTLC is a most versatile technique and is known for uniformity, purity profile, assay values and precision and accuracy of results. It can handle several samples of even different nature and composition. HPTLC is a modern analytical separation method with extensive versatility, although already much utilized, is still with great potential for future development in research and development.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
2. Indian Pharmacopoeia Commission (IPC)
• Vision
▫ The IPC is committed to the promotion of the
highest standards for drugs for use in the
prevention and treatment of diseases in human
beings and animals keeping in view the special
features of the pharmaceutical industry in India.
2
3. INDIAN PHARMACOPOEIA
MONOGRAPH DEVELOPMENT
• Objectives:
▫ The overall objective has been the creation of a
compilation of standards that reflect the state of the
industry in the country and the production and testing
capabilities of units varying in size from the small to the
very big.
▫ Special efforts have been made to safeguard the interests of
the weaker sectors of the industry without compromising
the safety and efficacy of the medicines included in the
Indian Pharmacopoeia (IP).
3
4. Features:
• Priority is given to monographs of drugs included in the
National Essential Drugs List and their dosage forms
• Regular up-gradation of monographs but consistent with
the level and degree of sophistication acceptable to the
majority of manufacturers.
• Harmonization of IP standards with international
acceptance criteria for drug quality
4
5. Quality Standards:
Following points should be under consideration
during setting of standards:
• Neither high nor low
• Should not be avoidance of sophisticated
instrumentation or methodology
• Recognition of the difficulties of the small- and
medium sized units of the industry
5
6. Quality Standards cont… :
• Retention of simple tests where complicated methods
offer no advantage
• No compromise on limitation of toxic impurities
• Gradual tightening of standards over the years
6
7. Overall philosophy:
• The Indian Pharmacopoeia is the official book of
standards and medicines produced in India must
comply with the specified standards.
• Pharmacopoeial standards and acceptance criteria are
set with the intention that they should be used only as
compliance requirements and not as requirements to
guarantee total quality assurance.
7
8. Overall philosophy cont…:
• Pharmacopoeial standards are the minimum ones with
which a manufacturer must comply before release of a
product for sale or distribution
• It is recognized that changes in quality may occur during
storage and distribution and the Pharmacopoeial
requirements are set to define acceptable levels of change
and to reject materials or products showing unacceptable
levels
8
9. Overall philosophy cont…:
• It is the responsibility of the manufacturer to ensure
that the product is manufactured in accordance with
current Good Manufacturing Practices.
• Pharmacopoeial requirements for drug substances
have been drawn up to provide appropriate limits for
potential impurities rather than to provide against all
possible impurities and adulterants.
9
10. Contents of the Pharmacopoeia
• The technical part of the pharmacopoeia shall be
broadly divided into the following sections:
1. Introduction
2. General Notices
3. Monographs
4. Test methods
5. Reagents and Solutions
6. General Texts
7. Index
10
11. Formats and Contents of Monographs
1. A one-column format shall be used for all the pages
of the monographs.
2. The font shall be Arial and the size for the text
matter shall be 10 pt.
3. Reagents, buffer solutions, chemicals other
substances that are described or defined in the
Pharmacopoeia shall be in italics.
4. Italic types shall also be used for the systematic
names of plants and micro- organisms, and for some
sub-headings of tests and texts and for some parts of
the chemical names.
11
12. 5. Titles of monographs and headings of tests must be
began with capital letters in bold letters and aligned on
the left with the text. Synonyms, if any, shall be printed
two spaces below the main title and shall not be in bold
letters.
6. Single-line spacing shall be followed and the alignment
of the text of the monograph shall be ‘justified’. Each
test parameter and the accompanying text shall be
separated from the other by a space of 1.5 lines.
7. Given in the following pages are directions on the
manner in which the various tests and assays are to be
described. Where the instructions are in red, the texts
shall appear in the monographs in exactly the same way
as shown.
12
13. A. Active Pharmaceutical Ingredients
(APIs) (Bulk Drug Substances)
Chemical Excipients
1. Title of the Monograph
• Name of the item in bold letters in font Arial size 12 pt. The INN
approved by the WHO shall be used.
• Synonym shown below the main title (in ordinary letters) The main
monograph headings viz. Identification and Tests etc. shall be in
Arial size 11 pt, and the headings of the individual tests in size 10
pt, and all in bold letters
e.g. Sodium Aminosalicylate
Sodium PAS
2. Formula
• Structural (Graphic) Formula
• The molecular formula on the left and the molecular weight
expressed to one decimal place on the right, two spaces below the
graphic formula.
13
14. 3. Chemical name: Ethionamide is 2-ethylpyridine-4-
carbothioamide.
4. Statement of purity: Ethionamide contains not less than
98.5 per cent and not more than 101.0 per cent of
C8H10N2S, calculated on the dried basis.
5. Description: A pale yellow oil with slight, but not rancid
odour.
6. Identification: The tests shall be marked with the letters
A, B, C and so on followed by a dot and then the text
after one space.
e.g. A. Determine by infrared absorption spectropho
tometry (2.2.40). Compare the spectrum with that
obtained with ceftazidime RS or with the reference
spectrum of ceftazidime.
14
15. 7. Appearance of solution: The solution is clear and not
more intensely coloured than reference solution.
8. pH
9. Specific optical rotation
10.Light-absorbing impurities : The absorbance (2.2.25)
of the resulting solution, determined at 495 nm is not
more than 0.07 calculated on the dried basis.
11.Related substances: Details of the method-usually by
thin-layer, or liquid chromatography or gas
chromatography shall be given.
12.Arsenic: Method of preparing the test solution shall be
given. The resulting solution complies with the limit test
for arsenic.
15
17. 22. Pyrogens
23. Sulphated ash: Not more than 0.1 per cent, determined on 2.0 g
24. Water
25. Loss on drying: Not more than 1.0 per cent, determined on 5.0 g
by drying in an oven at 100 to 105 .
26. Assay: Determine by liquid chromatography
• Test solution. Directions for preparing to be given
• Reference solution. – do –
• Chromatographic system:
• Details of the column,
• Mobile phase composition and flow rate,
• Detector and wavelength setting,
• Injection device (if any), and
• Any other detail.
17
18. 27.Storage: Store at a temperature not exceeding 30 . If
the substance is sterile, store in a sterile, airtight,
tamper-proof container.
28.Labelling: Any special labelling statements specific
to the product is given.
18
19. B. Inactive Ingredients other than Chemicals,
Drugs of Plant Origin
1. Title of the Monograph : Name in bold letters and font size
13pt.
2. Opening Statement: Must define the article
e.g. Activated Charcoal is obtained from vegetable matter by
suitable carbonisation processes intended to confer a high
adsorbing power.
3. Description, Identification and other tests, including
Assay
4. Relative density
5. Weight per ml
6. Refractive index
7. Melting point
8. Freezing point: Not less than xxx
19
20. 9. Viscosity: x mPa.s to y mPa.s
10. Peroxide value, Acid value, Ester value
11. Unsaponi-fiable matter, Acetyl value, Hydroxyl value,
Saponi-fication value
12. Iodine value
13. Acidity
14. Foreign matter, Total ash, Ash insoluble in hydrochloric
acid
15. Storage
16. Labelling
20
21. C. Dosage Forms
1. Title of the Monograph: Name in bold letters in
font size 13 pt
2. Description: For parenteral preparations information
shall be provided whether it is a solution, a
suspension, a dry powder
3. Content statement
4. Identification
5. Related substances/ Impurities: Tests for related
substances or impurities arising on manufacture or
storage of the dosage form shall be included.
21
22. 6. Specific tests: For Aspirin Tablets: Salicylic acid.
7. Disintegration
8. Dissolution
9. Assay
10.Storage
11.Labelling
22
23. D. Vaccines, Immunosera and Products
of Plant Origin
1. An opening statement that defines the preparation .
2. Production. The details of the method of producing
the product shall be described.
3. Identification.
4. Tests. Details of specific tests including sterility,
toxicity, potency or assay shall be given
23
24. E. General Monographs on Dosage
Forms
The dosage forms for which General Monographs may be written are
as follows:
• Capsules
• Ear preparations
• Eye preparations
• Granules
• Liquids for oral use
• Nasal Preparations
• Parenteral preparations
• Oral powders
• Preparations for inhalation
• Creams and Ointments
• Rectal and vaginal preparations
• Tablets .
24
25. The General Monographs shall be generally in three
sections:
A. General description or definition of the dosage form
and its different types.
B. Specific aspects of production that impact on the
quality of the product.
C. Tests to be done in addition to the ones set out in
the individual monographs.
25