SlideShare a Scribd company logo
1 of 32
Scale - Up and Post Approval Changes SUPAC Presented By:- Sonia  P. Nagvenkar 1
Index Definition Scientific Rational SUPAC Guidelines – SUPAC IR, SUPAC – MR, SUPAC –SS Levels of Change Components and composition Manufacturing Site Changes Batch size change (Scale up) Manufacturing change : Process & Equipment Limitations of SUPAC 2
Bioequivalent to the FDA reference listed drug (RLD)product Generic Drug Product Larger Batch size  ANDA or AADA approved by FDA SCALE UP 3
What is SUPAC In the process of developing a new drug product, the batch sizes used in the earliest human studies are small.  The size of the batches is gradually increased (Scale - up).  The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and Post approval Changes, or SUPAC.  4
Scientific Rationale 5 to expedite the processes of post approval changes of drug products  FDA can assure their safety and effectiveness.  lower the regulatory burden for industry.
6 The FDA has issued various guidances for SUPAC changes designated as  A. SUPAC-IR (for immediate-release solid oral dosage forms),  B. SUPAC-MR (for modified-release solid oral dosage forms), and  C. SUPAC-SS (for non-sterile semisolid dosage forms including creams, ointments, gels, and lotions).
SUPAC  GUIDELINES - DEFINE ,[object Object]
Moderate change
Major change
Application / Compendial Tests
In Vitro Dissolution / Release
In Vivo
Annual Report
Changes Being Effected Supplement
Prior Approval SupplementLevel of  Changes Tests Filing 7
	Likelihood of impact on formulation quality and performance Level  1: unlikely to have detectable impact Level  2: could have significant impact Level  3: likely to have significant impact  Levels  of change 8
These guidelines provide recommendations for  post approval changes in  (1) the components or composition,  (2) the site of manufacture, (3) the scale-up of manufacture, and  (4) the manufacturing (process and equipment)  9
Components & Composition 10 This section focuses on changes in excipients in the drug product SUPAC-MR: Excipient critical or non critical to the drug release.   - Changes in non release controlling excipients   - Changes in release controlling excipients SUPAC-SS: Changes in preservative
SUPAC - IR 11
12
13
SUPAC – MR   Non Release Controlling Excipients 14
SUPAC – MR   Release Controlling Excipients 15
SUPAC – SS    Components and Composition 16
SUPAC – SS    Components and Composition - Preservative 17
Manufacturing Site Changes changes in location of the site of manufacture, packaging operations  and/or analytical testing laboratory do not include any scale-up changes, changes in manufacturing (including process and/or equipment), or changes in components or composition.  current Good Manufacturing Practice (CGMP) inspection. 18
19
20
21
Batch Size Change (Scale Up) changes in the size of a batch from the pivotal/pilot scale biobatch material to larger production batches compliance with CGMP's No change in SOP, formulation and manufacturing procedures or equipments used All scale-up changes should be properly validated the minimum batch size for the pivotal clinical trial batch or biobatch be at least 100000 dosage units /100 kg or 10%of a production batch, whichever is larger. 22
23
Manufacturing Changes 24 Changes affecting:     - Equipments     - Manufacturing process Appropriate validation studies are conducted

More Related Content

What's hot

Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...Audumbar Mali
 
Regulatory requirements for drug approval
Regulatory requirements for drug approval Regulatory requirements for drug approval
Regulatory requirements for drug approval Namdeo Shinde
 
Pilot plant scale up techniques
Pilot plant scale up techniquesPilot plant scale up techniques
Pilot plant scale up techniquesSujit Patel
 
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )JAYACHANDRA AKUTHOTA
 
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTCopp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTSuraj Pamadi
 
Hatch waxman act & amendments ppt
Hatch waxman act & amendments  pptHatch waxman act & amendments  ppt
Hatch waxman act & amendments pptAlexa Jacob
 
Technology development & transfer by devill
Technology development & transfer by devillTechnology development & transfer by devill
Technology development & transfer by devillSnake EYE
 
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)Suvarta Maru
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )JAYACHANDRA AKUTHOTA
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]Sagar Savale
 
Generic drugs product development
Generic drugs product developmentGeneric drugs product development
Generic drugs product developmentSachin G
 

What's hot (20)

Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
Industrial Pharmacy-II (IP-II) Unit 2:- chapter:- 2 Technology Development an...
 
Regulatory requirements for drug approval
Regulatory requirements for drug approval Regulatory requirements for drug approval
Regulatory requirements for drug approval
 
Pilot plant scale up techniques
Pilot plant scale up techniquesPilot plant scale up techniques
Pilot plant scale up techniques
 
Supac
SupacSupac
Supac
 
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
 
Quality by Design ( QbD )
Quality by Design ( QbD )Quality by Design ( QbD )
Quality by Design ( QbD )
 
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTCopp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
 
Hatch waxman act & amendments ppt
Hatch waxman act & amendments  pptHatch waxman act & amendments  ppt
Hatch waxman act & amendments ppt
 
Regulatory affairs
Regulatory affairsRegulatory affairs
Regulatory affairs
 
Quality Risk Management
Quality Risk ManagementQuality Risk Management
Quality Risk Management
 
Technology development & transfer by devill
Technology development & transfer by devillTechnology development & transfer by devill
Technology development & transfer by devill
 
Polymers in controlled release Drug Delivery System
Polymers in controlled release Drug Delivery SystemPolymers in controlled release Drug Delivery System
Polymers in controlled release Drug Delivery System
 
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)
 
Master formula record
Master formula recordMaster formula record
Master formula record
 
Master formula record
Master formula recordMaster formula record
Master formula record
 
Drug development team
Drug development teamDrug development team
Drug development team
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]
 
Generic drugs product development
Generic drugs product developmentGeneric drugs product development
Generic drugs product development
 
Granularity of TT Process.pdf
Granularity of TT Process.pdfGranularity of TT Process.pdf
Granularity of TT Process.pdf
 

Similar to Supac

Scale up post approval changes
Scale up post approval changesScale up post approval changes
Scale up post approval changesROHIT
 
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval  changes for RA 1st sempptxSUPAC(Scale Up and Post Approval  changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval changes for RA 1st sempptxCharmi13
 
Scale Up And Post Approval Changes (SUPAC)
Scale Up And Post Approval Changes (SUPAC)Scale Up And Post Approval Changes (SUPAC)
Scale Up And Post Approval Changes (SUPAC)Prabhjot kaur
 
Supac For Modified Relese Dosage Form
Supac For Modified Relese Dosage FormSupac For Modified Relese Dosage Form
Supac For Modified Relese Dosage FormMalay Jivani
 
Chap 1_ SUPAC mpharm quality assurance semester 2
Chap 1_ SUPAC mpharm quality assurance semester 2Chap 1_ SUPAC mpharm quality assurance semester 2
Chap 1_ SUPAC mpharm quality assurance semester 2christinajohn24
 
Supac - Guidance for Modified Release Dosage Form
Supac - Guidance for Modified Release Dosage FormSupac - Guidance for Modified Release Dosage Form
Supac - Guidance for Modified Release Dosage FormJubiliant Generics Limited
 
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptx
IN VIVO AND  SCALE-UP  PROCESS APPROVAL CHANGES.pptxIN VIVO AND  SCALE-UP  PROCESS APPROVAL CHANGES.pptx
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptxPawanDhamala1
 
scaleup and post approval modification.pptx
scaleup and post approval modification.pptxscaleup and post approval modification.pptx
scaleup and post approval modification.pptxPankajSharma446574
 
Supac and post marketing serveillance
Supac and post marketing serveillanceSupac and post marketing serveillance
Supac and post marketing serveillanceBhavyaJivrajani
 
Scale up process and post marketing survilence
Scale up process and post marketing survilenceScale up process and post marketing survilence
Scale up process and post marketing survilenceKAVITAAGRE
 

Similar to Supac (20)

Scale up post approval changes
Scale up post approval changesScale up post approval changes
Scale up post approval changes
 
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval  changes for RA 1st sempptxSUPAC(Scale Up and Post Approval  changes for RA 1st sempptx
SUPAC(Scale Up and Post Approval changes for RA 1st sempptx
 
Supac
SupacSupac
Supac
 
documentation in pharmaceutical industry
documentation in pharmaceutical industrydocumentation in pharmaceutical industry
documentation in pharmaceutical industry
 
SUPAC
SUPACSUPAC
SUPAC
 
Supac
SupacSupac
Supac
 
SUPAC.pptx
SUPAC.pptxSUPAC.pptx
SUPAC.pptx
 
Scale Up And Post Approval Changes (SUPAC)
Scale Up And Post Approval Changes (SUPAC)Scale Up And Post Approval Changes (SUPAC)
Scale Up And Post Approval Changes (SUPAC)
 
Supac
SupacSupac
Supac
 
SUPAC-IR.ppt
SUPAC-IR.pptSUPAC-IR.ppt
SUPAC-IR.ppt
 
Supac For Modified Relese Dosage Form
Supac For Modified Relese Dosage FormSupac For Modified Relese Dosage Form
Supac For Modified Relese Dosage Form
 
Chap 1_ SUPAC mpharm quality assurance semester 2
Chap 1_ SUPAC mpharm quality assurance semester 2Chap 1_ SUPAC mpharm quality assurance semester 2
Chap 1_ SUPAC mpharm quality assurance semester 2
 
SUPAC PART-1
SUPAC PART-1SUPAC PART-1
SUPAC PART-1
 
Supac - Guidance for Modified Release Dosage Form
Supac - Guidance for Modified Release Dosage FormSupac - Guidance for Modified Release Dosage Form
Supac - Guidance for Modified Release Dosage Form
 
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptx
IN VIVO AND  SCALE-UP  PROCESS APPROVAL CHANGES.pptxIN VIVO AND  SCALE-UP  PROCESS APPROVAL CHANGES.pptx
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptx
 
scaleup and post approval modification.pptx
scaleup and post approval modification.pptxscaleup and post approval modification.pptx
scaleup and post approval modification.pptx
 
Supac and post marketing serveillance
Supac and post marketing serveillanceSupac and post marketing serveillance
Supac and post marketing serveillance
 
Supac
SupacSupac
Supac
 
Scale up process and post marketing survilence
Scale up process and post marketing survilenceScale up process and post marketing survilence
Scale up process and post marketing survilence
 
Granulation
GranulationGranulation
Granulation
 

Recently uploaded

會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽
會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽
會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽中 央社
 
An Overview of the Odoo 17 Knowledge App
An Overview of the Odoo 17 Knowledge AppAn Overview of the Odoo 17 Knowledge App
An Overview of the Odoo 17 Knowledge AppCeline George
 
SURVEY I created for uni project research
SURVEY I created for uni project researchSURVEY I created for uni project research
SURVEY I created for uni project researchCaitlinCummins3
 
Spring gala 2024 photo slideshow - Celebrating School-Community Partnerships
Spring gala 2024 photo slideshow - Celebrating School-Community PartnershipsSpring gala 2024 photo slideshow - Celebrating School-Community Partnerships
Spring gala 2024 photo slideshow - Celebrating School-Community Partnershipsexpandedwebsite
 
male presentation...pdf.................
male presentation...pdf.................male presentation...pdf.................
male presentation...pdf.................MirzaAbrarBaig5
 
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...Nguyen Thanh Tu Collection
 
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文中 央社
 
PSYPACT- Practicing Over State Lines May 2024.pptx
PSYPACT- Practicing Over State Lines May 2024.pptxPSYPACT- Practicing Over State Lines May 2024.pptx
PSYPACT- Practicing Over State Lines May 2024.pptxMarlene Maheu
 
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading Room
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading RoomSternal Fractures & Dislocations - EMGuidewire Radiology Reading Room
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading RoomSean M. Fox
 
philosophy and it's principles based on the life
philosophy and it's principles based on the lifephilosophy and it's principles based on the life
philosophy and it's principles based on the lifeNitinDeodare
 
Championnat de France de Tennis de table/
Championnat de France de Tennis de table/Championnat de France de Tennis de table/
Championnat de France de Tennis de table/siemaillard
 
The basics of sentences session 4pptx.pptx
The basics of sentences session 4pptx.pptxThe basics of sentences session 4pptx.pptx
The basics of sentences session 4pptx.pptxheathfieldcps1
 
e-Sealing at EADTU by Kamakshi Rajagopal
e-Sealing at EADTU by Kamakshi Rajagopale-Sealing at EADTU by Kamakshi Rajagopal
e-Sealing at EADTU by Kamakshi RajagopalEADTU
 
Đề tieng anh thpt 2024 danh cho cac ban hoc sinh
Đề tieng anh thpt 2024 danh cho cac ban hoc sinhĐề tieng anh thpt 2024 danh cho cac ban hoc sinh
Đề tieng anh thpt 2024 danh cho cac ban hoc sinhleson0603
 
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...Krashi Coaching
 
Improved Approval Flow in Odoo 17 Studio App
Improved Approval Flow in Odoo 17 Studio AppImproved Approval Flow in Odoo 17 Studio App
Improved Approval Flow in Odoo 17 Studio AppCeline George
 
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...Nguyen Thanh Tu Collection
 
SPLICE Working Group: Reusable Code Examples
SPLICE Working Group:Reusable Code ExamplesSPLICE Working Group:Reusable Code Examples
SPLICE Working Group: Reusable Code ExamplesPeter Brusilovsky
 

Recently uploaded (20)

會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽
會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽
會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽會考英聽
 
An Overview of the Odoo 17 Knowledge App
An Overview of the Odoo 17 Knowledge AppAn Overview of the Odoo 17 Knowledge App
An Overview of the Odoo 17 Knowledge App
 
SURVEY I created for uni project research
SURVEY I created for uni project researchSURVEY I created for uni project research
SURVEY I created for uni project research
 
Spring gala 2024 photo slideshow - Celebrating School-Community Partnerships
Spring gala 2024 photo slideshow - Celebrating School-Community PartnershipsSpring gala 2024 photo slideshow - Celebrating School-Community Partnerships
Spring gala 2024 photo slideshow - Celebrating School-Community Partnerships
 
male presentation...pdf.................
male presentation...pdf.................male presentation...pdf.................
male presentation...pdf.................
 
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...
24 ĐỀ THAM KHẢO KÌ THI TUYỂN SINH VÀO LỚP 10 MÔN TIẾNG ANH SỞ GIÁO DỤC HẢI DƯ...
 
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文
會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文會考英文
 
PSYPACT- Practicing Over State Lines May 2024.pptx
PSYPACT- Practicing Over State Lines May 2024.pptxPSYPACT- Practicing Over State Lines May 2024.pptx
PSYPACT- Practicing Over State Lines May 2024.pptx
 
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading Room
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading RoomSternal Fractures & Dislocations - EMGuidewire Radiology Reading Room
Sternal Fractures & Dislocations - EMGuidewire Radiology Reading Room
 
philosophy and it's principles based on the life
philosophy and it's principles based on the lifephilosophy and it's principles based on the life
philosophy and it's principles based on the life
 
Championnat de France de Tennis de table/
Championnat de France de Tennis de table/Championnat de France de Tennis de table/
Championnat de France de Tennis de table/
 
IPL Online Quiz by Pragya; Question Set.
IPL Online Quiz by Pragya; Question Set.IPL Online Quiz by Pragya; Question Set.
IPL Online Quiz by Pragya; Question Set.
 
The basics of sentences session 4pptx.pptx
The basics of sentences session 4pptx.pptxThe basics of sentences session 4pptx.pptx
The basics of sentences session 4pptx.pptx
 
e-Sealing at EADTU by Kamakshi Rajagopal
e-Sealing at EADTU by Kamakshi Rajagopale-Sealing at EADTU by Kamakshi Rajagopal
e-Sealing at EADTU by Kamakshi Rajagopal
 
Đề tieng anh thpt 2024 danh cho cac ban hoc sinh
Đề tieng anh thpt 2024 danh cho cac ban hoc sinhĐề tieng anh thpt 2024 danh cho cac ban hoc sinh
Đề tieng anh thpt 2024 danh cho cac ban hoc sinh
 
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...
MSc Ag Genetics & Plant Breeding: Insights from Previous Year JNKVV Entrance ...
 
Improved Approval Flow in Odoo 17 Studio App
Improved Approval Flow in Odoo 17 Studio AppImproved Approval Flow in Odoo 17 Studio App
Improved Approval Flow in Odoo 17 Studio App
 
Including Mental Health Support in Project Delivery, 14 May.pdf
Including Mental Health Support in Project Delivery, 14 May.pdfIncluding Mental Health Support in Project Delivery, 14 May.pdf
Including Mental Health Support in Project Delivery, 14 May.pdf
 
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...
TỔNG HỢP HƠN 100 ĐỀ THI THỬ TỐT NGHIỆP THPT TOÁN 2024 - TỪ CÁC TRƯỜNG, TRƯỜNG...
 
SPLICE Working Group: Reusable Code Examples
SPLICE Working Group:Reusable Code ExamplesSPLICE Working Group:Reusable Code Examples
SPLICE Working Group: Reusable Code Examples
 

Supac

  • 1. Scale - Up and Post Approval Changes SUPAC Presented By:- Sonia P. Nagvenkar 1
  • 2. Index Definition Scientific Rational SUPAC Guidelines – SUPAC IR, SUPAC – MR, SUPAC –SS Levels of Change Components and composition Manufacturing Site Changes Batch size change (Scale up) Manufacturing change : Process & Equipment Limitations of SUPAC 2
  • 3. Bioequivalent to the FDA reference listed drug (RLD)product Generic Drug Product Larger Batch size ANDA or AADA approved by FDA SCALE UP 3
  • 4. What is SUPAC In the process of developing a new drug product, the batch sizes used in the earliest human studies are small. The size of the batches is gradually increased (Scale - up). The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and Post approval Changes, or SUPAC. 4
  • 5. Scientific Rationale 5 to expedite the processes of post approval changes of drug products FDA can assure their safety and effectiveness. lower the regulatory burden for industry.
  • 6. 6 The FDA has issued various guidances for SUPAC changes designated as A. SUPAC-IR (for immediate-release solid oral dosage forms), B. SUPAC-MR (for modified-release solid oral dosage forms), and C. SUPAC-SS (for non-sterile semisolid dosage forms including creams, ointments, gels, and lotions).
  • 7.
  • 15. Prior Approval SupplementLevel of Changes Tests Filing 7
  • 16. Likelihood of impact on formulation quality and performance Level  1: unlikely to have detectable impact Level  2: could have significant impact Level  3: likely to have significant impact  Levels  of change 8
  • 17. These guidelines provide recommendations for post approval changes in (1) the components or composition, (2) the site of manufacture, (3) the scale-up of manufacture, and (4) the manufacturing (process and equipment) 9
  • 18. Components & Composition 10 This section focuses on changes in excipients in the drug product SUPAC-MR: Excipient critical or non critical to the drug release. - Changes in non release controlling excipients - Changes in release controlling excipients SUPAC-SS: Changes in preservative
  • 20. 12
  • 21. 13
  • 22. SUPAC – MR Non Release Controlling Excipients 14
  • 23. SUPAC – MR Release Controlling Excipients 15
  • 24. SUPAC – SS Components and Composition 16
  • 25. SUPAC – SS Components and Composition - Preservative 17
  • 26. Manufacturing Site Changes changes in location of the site of manufacture, packaging operations and/or analytical testing laboratory do not include any scale-up changes, changes in manufacturing (including process and/or equipment), or changes in components or composition. current Good Manufacturing Practice (CGMP) inspection. 18
  • 27. 19
  • 28. 20
  • 29. 21
  • 30. Batch Size Change (Scale Up) changes in the size of a batch from the pivotal/pilot scale biobatch material to larger production batches compliance with CGMP's No change in SOP, formulation and manufacturing procedures or equipments used All scale-up changes should be properly validated the minimum batch size for the pivotal clinical trial batch or biobatch be at least 100000 dosage units /100 kg or 10%of a production batch, whichever is larger. 22
  • 31. 23
  • 32. Manufacturing Changes 24 Changes affecting: - Equipments - Manufacturing process Appropriate validation studies are conducted
  • 33. Manufacturing Changes - Equipments 25
  • 35. 27
  • 36. 28
  • 37. Dissolution Profile Comparison Using Similarity Factor, f2 FDA has placed more emphasis on a dissolution profile comparison in the area of post-approval changes Among several methods investigated for dissolution profile comparison, f2 is the simplest. f2 = 50 + log {[1+ (1/n) ∑t=1 * n (Rt-Tt)2]-0.5 *100} (where Rt and Tt are the cumulative percentage dissolved at each of the selected n time points of the reference and test product respectively. When the two profiles are identical, f2=100. FDA has set a public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles. 29
  • 38. SUPAC  limitations  SUPAC:       ► has not been updated (1995/97 for main guides)       ► does not discuss multiple changes       ► does not cover modified equipment        ► must be used in conjunction with other  references, e.g. excipient  handbook 30
  • 40. 32