Its for 1st year student of m.pharm for the subject regulatory affairs

1. • GUIDE BY : PROF. SOMNATH VIBHUTE
• PRESENTED BY :PRIYATALEKAR
Date : 31/01/2022
RAJARSHI SHAHU COLLEGE OF PHARMACY
Scale up and post approval changes

2. • Contents
• Introduction
• What is SUPAC
• History and background
• What is SUPAC guidelines?
• Scales in SUPAC
• SUPAC levels
• Recently finalized SUPAC guidelines
• Benefit
• Reference

3. INTRODUCTION
• SUPAC stands for scale up and post approval changes.
• It is a technology of transfer of pharmaceutical product from research
to the production with gradually increase in production output(Batch
size) is commonly known as scale up.
• Also,The manufacturer may change. Drug formulation, batch size,
process, equipment, manufacturing site and there Identity, strength,
quality, purity and potency after the approvel known as post approval
changes.
•“The scale up and the changes made after approval in the composition
of product equipments and change of site,it is known as scale up and
post approval changes (supac).”

4. • HISTORY AND BACKGROUND
• On november 21,1997 the food and drug administration
modernization act (FDAMA) was signed into law.
• The FDAMA initiative was directed at providing more
definite language to the current food and cosmatic act.
• FDAMA added section 506A (21U.S.c 365a) to the FD&C
act, which provided specific language for manufacturing
changes to an approved application and reporting
requirement for those changes.

5. FDAMAPROVIDED FOR FOUR REPORTINGCATEGORIES
• Prior approval changes:Major changes that require FDA
approval before implementation.
• Supplementchanges beingeffected(30 days): Moderate
changesthat require 30 day’s notice before implementation.
• Supplement changesbeing effected (0 days): Moderate
changesthat canbe implementedimmediately.
• Annual report: Minor changes that can be implemented
immediatelyand filed in the next periodic report.

6. • SUPAC GUIDELINES:
• Definition:
• The scale up process and changes made after the
approval in composition, manufacturing process,
manufacturing equipment and change of site is
collectively called as SUPAC.
• It is a guideline that comes under Chemistry
Manufacturing and controls section of USFDA.
• During a stage of F&D, initially, development process is
carried out in small batch sizes generally in the multiples
of 10X i.e., small scale or lab scale.

7. • Then this batches are increased to multiples of 100X,
medium scale or pilot scale.
• While in production scale or large scale, manufacturing
is carried out in large numbers usually multiples of
1000X depending upon the requirement.
• Hence while making such a changes from lab scale to
pilot scale or to plant scale, submission of all this data
including excipients, their purpose and quantities to FDA
is necessary for getting the marketing approval.

8. • During a stage of F&D or as per market requirement
need of changes in composition of excipients, batch
size, manufacturing site, & equipment may arises ,then
in such a condition SUPAC provides a guideline related
to those changes under the different headings like-
• Components and composition
• Site changes
• Manufacture process
• Change in batch size.

10. • Level of changes as per supac:
• Level 1 (Minor Changes): level 1 change is the one assumed to
be that such change will not have any significant effect on
product's performance orquality. Ex. Change in colour
• Level 2(Moderate Changes):These are said to be those changes
that could have significant impact on the product quality and
performance.Example Changes in the technical grade of
excipient (Avicel PH102 vs. Avicel PH200)
• Level-3( Major Changes):These are said to be those changes
that could have significant impact on the product quality and
performance and these changes are required to be carried
out according to guidelines.

12. • Benefit of supac:
• From all the data we can say that SUPAC guideline is
regulatory relaxation to industries that avoids the
resubmission of entire data for every small changes as per
requirement or according to market requirement and
needs.

14. REFERENCES
• Shargel.L,Kanfer.I,Generic drug product development (solid
dosage form), Scale up, post- approvalchanges and post-
marketingsurveillancepage no.281
• FDA. Center for Drug Evaluation and Research, Guidance for
Industry: Immediate Release Solid Oral Dosage Forms. Scale-up
and Post-Approval Changes:
• https://www.researchgate.net/publication/316021703_SCALE_U
P_A8_POSTAPPROVAL_CHANGES_SUPAC_GUIDANCE_FOR_IND
USTRY_A_REGULATORY_NOTE

15. THANK YOU