COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
Electrophoresis principle and types by Dr. Anurag YadavDr Anurag Yadav
the general principle on how the electrophoresis performs.
the different types of electrophoresis and the mechanism of separation based on different character of the medium and type of electrophoresis.
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
Introduction to Scale up and post approval changes.
SUPAC Guidelines :
1.In component and composition
2.The site of manufacture
3.The scale up batch of manufacture
4.The manufacturing( equipment and process)
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
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
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- 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
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.
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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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
3. The acronym "SUPAC" stands for "Scale-Up and Post-
Approval Changes".
It refers to the FDA-recommended testing and filing
actions to be taken by a pharmaceutical firm when it
changes the manufacturing processes of a drug product
that has been approved via a New Drug Application
(NDA), an Abbreviated New Drug Application (ANDA), or
an Abbreviated Antibiotic Drug Application (AADA).
The Agency has provided its recommendations to
industry in the form of Guidances.
3
4. INTRODUCTION
This guidance provides recommendations to
sponsors of new drug applications (NDA's),
abbreviated new drug applications (ANDA's), and
abbreviated antibiotic applications (AADA's) who
intend, during the postapproval period, to change:
the components or composition;
the site of manufacture;
the scale-up/scale-down of manufacture; and/or
the manufacturing (process and equipment)
4
5. This guidance is the result of
1) a workshop on the scale-up of immediate release
drug products conducted by the American
Association of Pharmaceutical Scientists in
conjunction with the United States Pharmacopoeial
Convention and the Food and Drug Administration
(FDA)
2) Research conducted by the University of Maryland
at Baltimore on the chemistry, manufacturing and
controls of immediate release drug products under
the FDA/University of Maryland Manufacturing
Research Contract;
3) the drug categorization research conducted at the
University of Michigan and the University of Uppsala
on the permeability of drug substances;
5
6. 4)the Scale Up and Post Approval Changes (SUPAC)
Task Force which was established by the Center for
Drug Evaluation and Research (CDER) Chemistry,
Manufacturing and Controls Coordinating Committee
to develop guidance on scale-up and other
postapproval changes
6
7. The guidance defines:
1) levels of change;
2) recommended chemistry, manufacturing, and
controls tests for each level of change;
3) in vitro dissolution tests and/or in vivo
bioequivalence tests for each level of change; and
4)documentation that should support the change.
7
8. 21 CFR 314.70 provides instructions for how changes to
approved manufacturing process should be reported to
the Agency.
Why do the SUPAC Guidances offer an advantage over
the regulations?????
The documents are specific for particular dosage
forms.
To date, two Guidances have been finalized. They are:
8
9. Immediate Release Solid Oral Dosage Forms---Scale-
Up and Post-Approval Changes:
Chemistry, Manufacturing and Controls, In Vitro
Dissolution Testing, and In Vivo Bioequivalence
Documentation (November 1995)
Nonsterile Semisolid Dosage Forms---Scale-Up and
Post-Approval Changes:
Chemistry, Manufacturing and Controls; In Vitro
Dissolution Testing and In Vivo Bioequivalence
Documentation (May 1997)
In addition, SUPAC documents covering other dosage
forms (e.g., extended-release products, transdermals,
parenteral solutions), as well as a related document(s) for
bulk active substances, are at various stages of
development.
9
10. SUPAC-IR
FDA issued the first of its SUPAC guidances in nov
1995
This guidance addressed scale-up and PACs for
immediate release oral solid dosage forms
When making equipment changes ,the FDA’s
SUPAC-IR/MR immediate release and modified
release solid oral dosage forms Manufacturing
Equipment Addendum ,released in january 1999 has
to be followed This addendum lists various types
of equipment and categorises them into operating
classes and subclasses 10
11. SUPAC-IR Q&A
In feb 1997,the FDA issued a letter containing the
most frequently asked questions regarding SUPAC
The clarification regarding stand-alone packing site
changes
The second change reffered to post-approval
analytical testing site changes
11
12. PAC-ALTS
In april 1998 the FDA issued the PAC-ATLS (post
approval changes-analytical testing laboratory site)
guidance document allowing analytical testing
laboratory site changes for all regulated dosage form
12
13. LEVELS OF CHANGES
3 levels of changes:
level 1
level 2
level 3
LLeevveell 11:: This level 1 changes may be filed in an
annual report and have no detectable impact on
formulation quality or performance
13
14. LEVEL 2: They could have significant impact on
formulation quality and performance and thus filed
in a changes being effected(CBE) supplement or
prior approval (PA) supplement
This tests and filing depends on therapeutic range
,solubility, permeability
LEVEL3:This changes are likely to have impact on
Rx quality and performance and are thus filed in PA
supplement
This tests and filing documentation vary ,depending
on therapeutic range,solubility,and permeability of
the pharmaceutical product
14
15. COMPONENTS
&COMPOSITION
This section of the guidance focuses on changes in
excipients in the drug product
Changes in the amount of drug substance are not
addressed by this guidance.
Changes in components or composition that have
the effect of adding a new excipient or deleting an
excipient are defined at Level 3
15
16. LEVEL 1:
Examples:
a. Deletion or partial deletion of an ingredient intended
to affect the color or flavor of the drug product; or
change in the ingredient of the printing ink to
another approved ingredient
b. Changes in excipients, expressed as percentage
(w/w) of total formulation, less than or equal to the
following percent ranges:
16
18. Test Documentation
a. Chemistry Documentation
Application/compendial release requirements and
stability testing.
Stability testing: one batch on long-term stability
data reported in annual report.
b. Dissolution Documentation
None beyond application/compendial requirements.
c. In Vivo Bioequivalence Documentation
None.
18
20. LEVEL 2 CHANGES
Examples:
Change in the technical grade of an excipient.
(Example: Avicel PH102 vs. Avicel PH200.)
Changes in excipients, expressed as percent (w/w)
of total formulation, greater than those listed above
for a Level 1 change but less than or equal to the
following percent ranges (which represent a two fold
increase over Level 1 changes):
20
23. 23
Test Documentation
a.Chemistry Documentation
Application/compendial release requirements and
batch records.
Stability testing: 1 batch with 3 months accelerated
stability data in supplement and 1 batch on long-term
stability.
24. Dissolution Documentation
Case A: High Permeability, High Solubility Drugs
Dissolution of 85% in 15 minutes in 900
mL of 0.1N HCl. If a drug product fails to meet this
criterion, the applicant should perform the tests
described for Case B or C (below).
Case B: Low Permeability, High Solubility Drugs
Multi-point dissolution profile should
be performed in the application/compendial medium
at 15, 30, 45, 60 and 120 minutes or until an
asymptote is reached. The dissolution profile of the
proposed and currently used product formulations
should be similar 24
25. Case C: High Permeability, Low Solubility Drugs
Multi-point dissolution profiles should be
performed in water, 0.1 N HCl, and USP buffer
media at pH 4.5, 6.5, and 7.5 (five separate profiles)
for the proposed and currently accepted
formulations. Adequate sampling should be
performed at 15, 30, 45, 60, and 120 minutes until
either 90% of drug from the drug product is dissolved
or an asymptote is reached. A surfactant may be
used, but only with appropriate justification. The
dissolution profile of the proposed and currently used
product formulations should be similar.
25
26. c. In Vivo Bioequivalence Documentation
None: if the situation does not meet the description in
Case A, Case B or Case C, refer to Level 3 changes.
Filing Documentation
Prior approval supplement (all information including
accelerated stability data); annual report (long-term
stability data).
26
27. LEVEL 3
Examples:
a.Any qualitative and quantitative excipient changes to
a narrow therapeutic drug beyond the ranges noted
in level 1
b. All other drugs not meeting the dissolution criteria
under level 2
c. Changes in the excipient ranges of low solubility,
low permeability drugs beyond Changes in the
excipient ranges of all drugs beyond 2x level 1
27
28. Test documentation
a.Chemistry Documentation
Application/compendial release requirements and
batch records.
Significant body of information available:
One batch with three months accelerated stability
data reported in supplement; one batch on long-term
stability data reported in annual report.
Significant body of information not available:
Up to three batches with three months
accelerated stability data reported insupplement; one
batch on long-term stability data reported in annual
report. 28
29. Dissolution Documentation
Case B dissolution profile as described in Section
III.B.2.b.
In Vivo Bioequivalence Documentation
Full bioequivalence study. The bioequivalence study
may be waived with an acceptable in vivo/in vitro
correlation has been verified
29
30. Filing Documentation
Prior approval supplement (all information including
accelerated stability data); annual report (long-term
stability data).
30
59. 59
Phamaceutical process validation .ROBERT A NASH
pg no:705 to747:”change control and supac”-Nelie
helen waterland
Dupont pharmaceuticals co.,wilmington, Delaware,USA