This document outlines the FDA's SUPAC guidance for immediate release solid oral dosage forms. It defines three levels of changes to approved drug products: Level 1 changes require annual reporting, Level 2 prior approval or changes being effected supplements, and Level 3 prior approval supplements. The guidance provides recommendations for chemistry, dissolution, bioequivalence testing and documentation required for component/composition changes at each level. It aims to advise pharmaceutical firms on testing and regulatory filings needed when modifying approved manufacturing processes.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
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:
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Scale up and post approval changes guidelines for IR, MR and Non SS dosage form helps to changes in the composition, batch size , site of manufacturing and equipment and manufacturing process after the approval at large scale
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.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Transfer from R & D to production.pptxDipeshGamare
Transfer from R & D to production :
(Process, packaging and cleaning)
Granularity of TT Process :
(API, excipients, finished products, packaging materials)
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:
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Scale up and post approval changes guidelines for IR, MR and Non SS dosage form helps to changes in the composition, batch size , site of manufacturing and equipment and manufacturing process after the approval at large scale
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.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
Transfer from R & D to production.pptxDipeshGamare
Transfer from R & D to production :
(Process, packaging and cleaning)
Granularity of TT Process :
(API, excipients, finished products, packaging materials)
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)
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In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
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for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
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.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
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.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
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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.
2. CONTENTS
INTRODUCTION
Current Finalized SUPAC *SUPAC-IR
Components or Composition
Site of Manufacture
Scale-up/scale-down of manufacture
Manufacturing (process and equipment)
2
3. The "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 NDA, ANDA, or an Abbreviated Antibiotic
Drug Application (AADA).
The guidance defines:
1) levels of change; 2) recommended CMC 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.
3
4. 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:
4
5. 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.
5
6. SUPAC-IR
FDA issued the first of its SUPAC guidance 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 December 2014
has to be followed .This addendum lists various
types of equipment and categorises them into
operating classes and subclasses
6
7. 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.
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.
7
8. LEVELS OF CHANGES
3 levels of changes:
Level 1
Level 2
Level 3
Level 1: This level 1 changes may be filed in an
annual report and have no detectable impact on
formulation quality or performance
Submission Strategy : Annual Report
8
9. 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
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 Submission : PAS
9
10. Component & Composition Level 1 Change :
Annual Report
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
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:
10
12. 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.
d. Filing Documentation
Annual report (all information including long-term
stability data).
12
13. Component & Composition Level 2 Change : PAS
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):
13
15. 15
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.
16. 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.
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. 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
16
17. 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).
17
18. Component & Composition Level 3 Change : PAS
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
18
19. 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.
19
20. 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
Filing Documentation
Prior approval supplement (all information including
accelerated stability data); annual report (long-term
stability data).
20