SlideShare a Scribd company logo
1 of 7
SUPAC - Scale-Up and
Post-Approval Changes
SUPAC guideline is prepared by the American Association of Pharmaceutical Scientists (AAPS)
in association with the United States Food & Drug Administration (FDA) and the United
States Pharmacopeia (USP).
The guideline looks into manufacturing procedures, and
compositional modification changes during scale-up and post-
approval in drug production.
In pharmaceutical technology, the transfer of a pharmaceutical
product from small scale (research) to the production scale –
an increase in batch size from small scale to large scale – is
termed scale-up with an increase in simultaneous production
outputs. In general, the process of increase in batch size is
termed scale-up. This process is required for in-depth study
and knowledge about the product which needs to be
manufactured at a larger scale
The scale-up process and the changes made after approval in the manufacturing process,
equipment, composition, and change in the site are known as scale-up and post-approval
changes or SUPAC. It is important to make sure that the applied process is capable enough to
manufacture an appropriate quality product and as well as to know that the product after
scale-up doesn’t suffer any changes in the physical and chemical properties of the product.
SUPAC Guidelines
SUPAC stands for Scale-up and Post Approval Changes. These guidelines state that when there
is any change during the post-approval phases, such as:
1. Manufacturing procedures or equipment,
2. Specifications,
3. Compositional or components change,
4. Change in manufacturing site,
5. Scale-up or Scale-down of batch size
The above depends on anticipated or unanticipated
requirements and there can be changes in the
process, raw materials, equipment, manufacturing
site, or batch size which may finally affect the
quality attributes of the drug or finished drug
product. Hence there is a need to anticipate and
evaluate the effectiveness of any kind of changes
on the final quality of a drug or drug product and
must ensure to take appropriate investigation and
submission action which has been authorized
by New Drug Application (NDA), Abbreviated New
Drug Application (ANDA) or by Abbreviated
Antibiotic Applications (AADA’s).
This guidance gets together and replaces the below-mentioned scale-up and post-approval
changes guide for the pharmaceutical industry:
SUPAC-IR/MR: Immediate-release tablets, capsules, soft gelatine
capsules, and modified-release oral solid dosage forms which include
delayed-release (DR) and extended-release (ER); Manufacturing
equipment addendum.
SUPAC-SS: Nonsterile semisolid dosage forms include creams,
ointments, gel, suspensions, emulsions, and Manufacturing
equipment addendum.
The post-approval changes in the drug CMC for ‘moderate’ and
‘major’ are allowed to be submitted in the annual report.
• Moderate: In case of moderate changes, the applicant must submit an addendum prior
to 30 days before the supply of drug product i.e. Change being effected (CBE)-30
supplement, or in some cases, an addendum can be submitted at the time of supply i.e.
CBE-0 supplement.
• Major: In case of major changes, the applicant must submit and receive FDA approval of
a prior approval supplement (PAS) before the distribution of the drug product.
The systematic aspect of SUPAC:
The SUPAC guidance summaries it identifies different levels of change.
Each level of change describes as per the below points:
Proposed chemistry,
manufacturing, and
control (CMC)
assessment
In-vitro dissolution
analysis or in-vivo
bioequivalence
analysis
The supporting
documents required
by the FDA are to be
filed in the NDA,
ANDA, or AADA.
Drug products manufactured with the proposed changes are as per below:
1. Change in components or composition
2. Change in manufacturing site
3. Scale up and scale down of manufacture
4. Change in manufacturing process and equipment
SUPAC guidance defines a different level of changes as per below:
1. Proposed chemistry
2. Manufacturing and controls tests for each level change
3. In-vitro dissolution testing and/or In-vivo bioequivalence tests for each level of change
4. Required documents to support filing.
SUPAC guidance is important considering the scale-up process related to chemistry
manufacturing and control. Scale-up is an important and expected stage of manufacturing
pharmaceutical drug products which can require an increase or decrease in the batch
size. It reduces the time of manufacturing, improves yield, and reduces cost.
FAQ
What is SUPAC’s full form?
SUPAC’s full form is Scale-up and Post-Approval Changes.
What is SUPAC?
It is not a guideline it is just a guidance document. This guidance states that when there is
any change during the post-approval phases, such as manufacturing procedures or
equipment, specifications, compositional or components change, change in
manufacturing site, or scale-up or scale-down of batch size.
What is SUPAC-IR/MR?SUPAC-IR/MR: Immediate-release tablets, capsules, soft gelatine
capsules, and modified-release oral solid dosage forms which include delayed-release
(DR) and extended-release (ER); manufacturing equipment addendum.
What is SUPAC-SS?
SUPAC-SS: Non-sterile semisolid dosage forms include creams, ointments, gel,
suspensions, emulsions, and Manufacturing equipment addendum.

More Related Content

Recently uploaded

20 Benefits of Empathetic Listening in Mental Health Support
20 Benefits of Empathetic Listening in Mental Health Support20 Benefits of Empathetic Listening in Mental Health Support
20 Benefits of Empathetic Listening in Mental Health SupportSayhey
 
Your Radiotherapy Destination Gokuldas Hospital.
Your Radiotherapy Destination Gokuldas Hospital.Your Radiotherapy Destination Gokuldas Hospital.
Your Radiotherapy Destination Gokuldas Hospital.Gokuldas Hospital
 
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGYANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGYDrmayuribhise
 
AI in Pediatrics: Taking Baby Steps in the Big World of Data
AI in Pediatrics: Taking Baby Steps in the Big World of DataAI in Pediatrics: Taking Baby Steps in the Big World of Data
AI in Pediatrics: Taking Baby Steps in the Big World of DataIris Thiele Isip-Tan
 
Field exchange, Issue 72 April 2024 FEX-72.pdf
Field exchange, Issue 72 April 2024 FEX-72.pdfField exchange, Issue 72 April 2024 FEX-72.pdf
Field exchange, Issue 72 April 2024 FEX-72.pdfMohamed Miyir
 
arpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationarpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationNursing education
 
The future of change - strategic translation
The future of change - strategic translationThe future of change - strategic translation
The future of change - strategic translationHelenBevan4
 
Enhancing Health Through Personalized Nutrition
Enhancing Health Through Personalized NutritionEnhancing Health Through Personalized Nutrition
Enhancing Health Through Personalized NutritionNeighborhood Trainer
 
Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...mauryashreya478
 
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in India
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in IndiaStaying Safe in Hospitals: Fire Safety Guidelines for Hospitals in India
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in IndiaBasic Elements
 
CASE STUDY ON CHRONIC KIDNEY DISEASE.pptx
CASE  STUDY ON CHRONIC KIDNEY DISEASE.pptxCASE  STUDY ON CHRONIC KIDNEY DISEASE.pptx
CASE STUDY ON CHRONIC KIDNEY DISEASE.pptxdrsriram2001
 
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...Panchmukhi Air& Train Ambulance Services
 
Mental Health for physiotherapy and other health students
Mental Health for physiotherapy and other health studentsMental Health for physiotherapy and other health students
Mental Health for physiotherapy and other health studentseyobkaseye
 
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...Compliatric Where Compliance Happens
 
Medisep insurance policy , new kerala government insurance policy for govrnm...
Medisep insurance policy , new  kerala government insurance policy for govrnm...Medisep insurance policy , new  kerala government insurance policy for govrnm...
Medisep insurance policy , new kerala government insurance policy for govrnm...LinshaLichu1
 
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...The Lifesciences Magazine
 
Learn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental FogginessLearn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental Fogginessbkling
 
Presentation for Alzheimers Disease.pptx
Presentation for Alzheimers Disease.pptxPresentation for Alzheimers Disease.pptx
Presentation for Alzheimers Disease.pptxravisutar1
 

Recently uploaded (20)

20 Benefits of Empathetic Listening in Mental Health Support
20 Benefits of Empathetic Listening in Mental Health Support20 Benefits of Empathetic Listening in Mental Health Support
20 Benefits of Empathetic Listening in Mental Health Support
 
Your Radiotherapy Destination Gokuldas Hospital.
Your Radiotherapy Destination Gokuldas Hospital.Your Radiotherapy Destination Gokuldas Hospital.
Your Radiotherapy Destination Gokuldas Hospital.
 
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGYANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
 
AI in Pediatrics: Taking Baby Steps in the Big World of Data
AI in Pediatrics: Taking Baby Steps in the Big World of DataAI in Pediatrics: Taking Baby Steps in the Big World of Data
AI in Pediatrics: Taking Baby Steps in the Big World of Data
 
Field exchange, Issue 72 April 2024 FEX-72.pdf
Field exchange, Issue 72 April 2024 FEX-72.pdfField exchange, Issue 72 April 2024 FEX-72.pdf
Field exchange, Issue 72 April 2024 FEX-72.pdf
 
Check Your own POSTURE & treat yourself.pptx
Check Your own POSTURE & treat yourself.pptxCheck Your own POSTURE & treat yourself.pptx
Check Your own POSTURE & treat yourself.pptx
 
arpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationarpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and education
 
The future of change - strategic translation
The future of change - strategic translationThe future of change - strategic translation
The future of change - strategic translation
 
Enhancing Health Through Personalized Nutrition
Enhancing Health Through Personalized NutritionEnhancing Health Through Personalized Nutrition
Enhancing Health Through Personalized Nutrition
 
Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...
 
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in India
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in IndiaStaying Safe in Hospitals: Fire Safety Guidelines for Hospitals in India
Staying Safe in Hospitals: Fire Safety Guidelines for Hospitals in India
 
Best Sharjah Spa Jameela Massage Center Sharjah
Best Sharjah Spa Jameela Massage Center SharjahBest Sharjah Spa Jameela Massage Center Sharjah
Best Sharjah Spa Jameela Massage Center Sharjah
 
CASE STUDY ON CHRONIC KIDNEY DISEASE.pptx
CASE  STUDY ON CHRONIC KIDNEY DISEASE.pptxCASE  STUDY ON CHRONIC KIDNEY DISEASE.pptx
CASE STUDY ON CHRONIC KIDNEY DISEASE.pptx
 
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...
Speedy patient rehabilitation by Panchmukhi Train Ambulance Services in Patna...
 
Mental Health for physiotherapy and other health students
Mental Health for physiotherapy and other health studentsMental Health for physiotherapy and other health students
Mental Health for physiotherapy and other health students
 
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...
2024 Compliatric Webinar Series - OSV Overview and Panel Discussion April 202...
 
Medisep insurance policy , new kerala government insurance policy for govrnm...
Medisep insurance policy , new  kerala government insurance policy for govrnm...Medisep insurance policy , new  kerala government insurance policy for govrnm...
Medisep insurance policy , new kerala government insurance policy for govrnm...
 
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
 
Learn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental FogginessLearn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental Fogginess
 
Presentation for Alzheimers Disease.pptx
Presentation for Alzheimers Disease.pptxPresentation for Alzheimers Disease.pptx
Presentation for Alzheimers Disease.pptx
 

Featured

How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024Albert Qian
 
Social Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsSocial Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsKurio // The Social Media Age(ncy)
 
Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
 
5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summarySpeakerHub
 
ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
 
Getting into the tech field. what next
Getting into the tech field. what next Getting into the tech field. what next
Getting into the tech field. what next Tessa Mero
 
Google's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentGoogle's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentLily Ray
 
Time Management & Productivity - Best Practices
Time Management & Productivity -  Best PracticesTime Management & Productivity -  Best Practices
Time Management & Productivity - Best PracticesVit Horky
 
The six step guide to practical project management
The six step guide to practical project managementThe six step guide to practical project management
The six step guide to practical project managementMindGenius
 
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...RachelPearson36
 
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Applitools
 
12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at WorkGetSmarter
 
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...DevGAMM Conference
 
Barbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationBarbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationErica Santiago
 
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them wellGood Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them wellSaba Software
 
Introduction to C Programming Language
Introduction to C Programming LanguageIntroduction to C Programming Language
Introduction to C Programming LanguageSimplilearn
 

Featured (20)

How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024How to Prepare For a Successful Job Search for 2024
How to Prepare For a Successful Job Search for 2024
 
Social Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie InsightsSocial Media Marketing Trends 2024 // The Global Indie Insights
Social Media Marketing Trends 2024 // The Global Indie Insights
 
Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024Trends In Paid Search: Navigating The Digital Landscape In 2024
Trends In Paid Search: Navigating The Digital Landscape In 2024
 
5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary5 Public speaking tips from TED - Visualized summary
5 Public speaking tips from TED - Visualized summary
 
ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd ChatGPT and the Future of Work - Clark Boyd
ChatGPT and the Future of Work - Clark Boyd
 
Getting into the tech field. what next
Getting into the tech field. what next Getting into the tech field. what next
Getting into the tech field. what next
 
Google's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search IntentGoogle's Just Not That Into You: Understanding Core Updates & Search Intent
Google's Just Not That Into You: Understanding Core Updates & Search Intent
 
How to have difficult conversations
How to have difficult conversations How to have difficult conversations
How to have difficult conversations
 
Introduction to Data Science
Introduction to Data ScienceIntroduction to Data Science
Introduction to Data Science
 
Time Management & Productivity - Best Practices
Time Management & Productivity -  Best PracticesTime Management & Productivity -  Best Practices
Time Management & Productivity - Best Practices
 
The six step guide to practical project management
The six step guide to practical project managementThe six step guide to practical project management
The six step guide to practical project management
 
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
 
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...
 
12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work12 Ways to Increase Your Influence at Work
12 Ways to Increase Your Influence at Work
 
ChatGPT webinar slides
ChatGPT webinar slidesChatGPT webinar slides
ChatGPT webinar slides
 
More than Just Lines on a Map: Best Practices for U.S Bike Routes
More than Just Lines on a Map: Best Practices for U.S Bike RoutesMore than Just Lines on a Map: Best Practices for U.S Bike Routes
More than Just Lines on a Map: Best Practices for U.S Bike Routes
 
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
Ride the Storm: Navigating Through Unstable Periods / Katerina Rudko (Belka G...
 
Barbie - Brand Strategy Presentation
Barbie - Brand Strategy PresentationBarbie - Brand Strategy Presentation
Barbie - Brand Strategy Presentation
 
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them wellGood Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
 
Introduction to C Programming Language
Introduction to C Programming LanguageIntroduction to C Programming Language
Introduction to C Programming Language
 

SUPAC - Scale-Up and Post-Approval Changes

  • 1. SUPAC - Scale-Up and Post-Approval Changes
  • 2. SUPAC guideline is prepared by the American Association of Pharmaceutical Scientists (AAPS) in association with the United States Food & Drug Administration (FDA) and the United States Pharmacopeia (USP). The guideline looks into manufacturing procedures, and compositional modification changes during scale-up and post- approval in drug production. In pharmaceutical technology, the transfer of a pharmaceutical product from small scale (research) to the production scale – an increase in batch size from small scale to large scale – is termed scale-up with an increase in simultaneous production outputs. In general, the process of increase in batch size is termed scale-up. This process is required for in-depth study and knowledge about the product which needs to be manufactured at a larger scale The scale-up process and the changes made after approval in the manufacturing process, equipment, composition, and change in the site are known as scale-up and post-approval changes or SUPAC. It is important to make sure that the applied process is capable enough to manufacture an appropriate quality product and as well as to know that the product after scale-up doesn’t suffer any changes in the physical and chemical properties of the product.
  • 3. SUPAC Guidelines SUPAC stands for Scale-up and Post Approval Changes. These guidelines state that when there is any change during the post-approval phases, such as: 1. Manufacturing procedures or equipment, 2. Specifications, 3. Compositional or components change, 4. Change in manufacturing site, 5. Scale-up or Scale-down of batch size The above depends on anticipated or unanticipated requirements and there can be changes in the process, raw materials, equipment, manufacturing site, or batch size which may finally affect the quality attributes of the drug or finished drug product. Hence there is a need to anticipate and evaluate the effectiveness of any kind of changes on the final quality of a drug or drug product and must ensure to take appropriate investigation and submission action which has been authorized by New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or by Abbreviated Antibiotic Applications (AADA’s).
  • 4. This guidance gets together and replaces the below-mentioned scale-up and post-approval changes guide for the pharmaceutical industry: SUPAC-IR/MR: Immediate-release tablets, capsules, soft gelatine capsules, and modified-release oral solid dosage forms which include delayed-release (DR) and extended-release (ER); Manufacturing equipment addendum. SUPAC-SS: Nonsterile semisolid dosage forms include creams, ointments, gel, suspensions, emulsions, and Manufacturing equipment addendum. The post-approval changes in the drug CMC for ‘moderate’ and ‘major’ are allowed to be submitted in the annual report. • Moderate: In case of moderate changes, the applicant must submit an addendum prior to 30 days before the supply of drug product i.e. Change being effected (CBE)-30 supplement, or in some cases, an addendum can be submitted at the time of supply i.e. CBE-0 supplement. • Major: In case of major changes, the applicant must submit and receive FDA approval of a prior approval supplement (PAS) before the distribution of the drug product.
  • 5. The systematic aspect of SUPAC: The SUPAC guidance summaries it identifies different levels of change. Each level of change describes as per the below points: Proposed chemistry, manufacturing, and control (CMC) assessment In-vitro dissolution analysis or in-vivo bioequivalence analysis The supporting documents required by the FDA are to be filed in the NDA, ANDA, or AADA.
  • 6. Drug products manufactured with the proposed changes are as per below: 1. Change in components or composition 2. Change in manufacturing site 3. Scale up and scale down of manufacture 4. Change in manufacturing process and equipment SUPAC guidance defines a different level of changes as per below: 1. Proposed chemistry 2. Manufacturing and controls tests for each level change 3. In-vitro dissolution testing and/or In-vivo bioequivalence tests for each level of change 4. Required documents to support filing. SUPAC guidance is important considering the scale-up process related to chemistry manufacturing and control. Scale-up is an important and expected stage of manufacturing pharmaceutical drug products which can require an increase or decrease in the batch size. It reduces the time of manufacturing, improves yield, and reduces cost.
  • 7. FAQ What is SUPAC’s full form? SUPAC’s full form is Scale-up and Post-Approval Changes. What is SUPAC? It is not a guideline it is just a guidance document. This guidance states that when there is any change during the post-approval phases, such as manufacturing procedures or equipment, specifications, compositional or components change, change in manufacturing site, or scale-up or scale-down of batch size. What is SUPAC-IR/MR?SUPAC-IR/MR: Immediate-release tablets, capsules, soft gelatine capsules, and modified-release oral solid dosage forms which include delayed-release (DR) and extended-release (ER); manufacturing equipment addendum. What is SUPAC-SS? SUPAC-SS: Non-sterile semisolid dosage forms include creams, ointments, gel, suspensions, emulsions, and Manufacturing equipment addendum.