CENTRE FOR PRODUCT REGISTRATION

NATIONAL PHARMACEUTICAL CONTROL BUREAU (NPCB)

Active Pharmaceutical Ingredient (API) Submission Checklist

Product Name :
Product Reference No. :
Product Registration Holder :
API Name:
API Manufacturer Name :
& Address
NO. / SECTIONS/
FIELDS / CONTENTS / APPLICANT / NPCB
ACTD / DMF / CEP
1. / Finish Product Information / Product name/dosage form
Active Ingredient (s)
Product Manufacturer
(Name & Address)
2. / API information / API Name
API Manufacturer (Name & Address)
Route of Synthesis
3. / Certificate of Suitability
*CEP Option / CEP No.
Date of issue
Written Statement
  • Name of the finished product

  • PRH responsible for the finished product

  • Written assurance

  • Declaration

4. / Drug Master File (DMF)
*DMF Option / DMF Version No.
Letter of Access
  • Name of the finished product

  • Local MAH responsible for the finished product

  • Declaration

5 / GMP
*Full ACTD & DMF Option / GMP certificate
Separate facilities for penicillin and cephalosporin manufacturing
Sterile facilities
6. / Drug Substance (Part II S) / S1. General information
S2. Manufacture
S2.1 Manufacturer (s)
S2.2 Description of
Manufacturing
Process and Process Controls
S2.3 Control of Materials
S2.4 Controls of Critical Steps
and Intermediates
S2.5 Process validation and/or
evaluation (sterile API only)
S2.6 Manufacturing Process
Development
S3. Characterisation and Impurities
S3.1 Elucidation of Structure
andother Characteristics
S3.2 Impurities
S4. Control of Drug Substance
S4.1 Specification
  • From API Manufacturer

  • From ProductManufacturer

S4.2 Analytical Procedures
S4.3 Validation of Analytical Procedures
S4.4 Batch Analysis
Certificate of Analysis of API
  • From API Manufacturer
(2 Batches)
  • From ProductManufacturer
(2 Batches)
S4.5 Justification ofSpecification
S5. Reference Standards or Materials
  • From API Manufacturer

  • From Product Manufacturer

S6. Container Closure System
S7. Stability
  • Proposed Re-test period / Shelf life
/ Please state / Please state / Please state
  • Proposed API Storage Condition (Temperature/Packaging)
(Please state API storage condition based on study condition of stability data provided (Store below..etc.)).
  • Stress Testing Study
(eg: moisture, light, acidic, basic,
oxidative and thermal stress
conditions).
  • Long term stability data
(3 batches)
(Temperature/RH/Packaging)
  • Accelerated stability data
(3 batches)
(Temperature/RH/Packaging)
7. / Other related documents
8. / Notes

Note:

- This checklist should be attached with each API submission.

- All information should be arranged according to the ACTD format.Each section should be divided and labeled using an index divider.

-Separate file should be submitted for each entity when:

  • Finished product contains more than one API
  • API manufactured from more than one manufacturing site
  • API manufactured using more than one synthesis route

- Please submit1 setof following documents to Lab Services Section, Centre for Quality Control, NPCB:

  • A cover letter (product name, product reference no., product registration holder, API name, API manufacturer)
  • From API Manufacturer:

S4 Control of Drug Substance

Certificate of Analysis of API(2 Batches)

S5 Reference Standards Or Materials

  • From Product Manufacturer:

S4.1 Specification of API

Certificate of Analysis of API(2 Batches)

S5 Reference Standards Or Materials

Submitted by: Received by:

………………………. ………………………….

(Date: ) (Date: )