Active pharmaceutical ingredient for generics
This presentation is the property of its rightful owner.
Sponsored Links
1 / 14

Active Pharmaceutical ingredient FOR GENERICS PowerPoint PPT Presentation


  • 78 Views
  • Uploaded on
  • Presentation posted in: General

Active Pharmaceutical ingredient FOR GENERICS. Presented By: Dr. Zeba Ahmed Shuja Director Technical, Schazoo Zaka Pvt. Ltd. Active Pharmaceutical ingredient. WHO Requirements: API: API Name Nomenclature Recommended INN Compendial name Chemical name Other non proprietary name

Download Presentation

Active Pharmaceutical ingredient FOR GENERICS

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Active pharmaceutical ingredient for generics

Active Pharmaceutical ingredient FOR GENERICS

Presented By:

Dr. Zeba Ahmed Shuja

Director Technical, Schazoo Zaka Pvt. Ltd.


Active pharmaceutical ingredient

Active Pharmaceutical ingredient

WHO Requirements:

API:

  • API Name

  • Nomenclature

  • Recommended INN

  • Compendial name

  • Chemical name

  • Other non proprietary name

  • CAS registry number

DRAP Requirements:

API:

  • API Name

  • No information required regarding chemical name etc.


Active pharmaceutical ingredient1

Active Pharmaceutical ingredient

WHO Requirements:

  • API Structure

  • Structural formula

  • Molecular formula

  • Molecular weight

  • General properties

  • Physical description

  • Solubility

  • Physical form

  • Stereochemistry polymorphism

DRAP Requirements:

  • No information is required regarding structure of the API, Molecular formula, or stereochemistry or polymorphism.


Active pharmaceutical ingredient2

Active Pharmaceutical ingredient

WHO Requirements:

  • Control of API

  • API specifications of API and FPP manufacturer

  • Container/ Closure system

DRAP Requirements:

  • API specifications of FPP manufacturer is required

  • No information required regarding container/closure system.


Active pharmaceutical ingredient3

Active Pharmaceutical ingredient

WHO Requirements:

  • Stability of API

  • Stability summary & conclusion

  • Proposed storage condition & retest period

DRAP Requirements:

  • No data regarding stability of the API is required like stability summary, proposed storage condition etc of the API.


Active pharmaceutical ingredient4

Active Pharmaceutical ingredient

WHO Requirements:

  • API Manufacturer

  • Name, address & responsibility

    (certificate of suitability

    , API master file)

  • Manufacturing authorization for production of API

  • Description of manufacturing process and

    process controls

DRAP Requirements:

  • No information regarding API manufacturing and manufacturing process is required.


Active pharmaceutical ingredient5

Active Pharmaceutical ingredient

  • WHO Requirements:

  • Manufacturing process flow diagram

  • Brief description of the manufacturing process

DRAP Requirements:

  • No flow diagram, or description of the manufacturing process is required.


Active pharmaceutical ingredient6

Active Pharmaceutical ingredient

WHO Requirements:

  • Control of Materials

  • Summary of the quality and controls of the starting materials

  • Name and manufacturing site address of starting material manufacturer(s):

DRAP Requirements:

  • No information related to control of materials, Summary of the quality and controls of the starting materials is required etc


Active pharmaceutical ingredient7

Active Pharmaceutical ingredient

WHO Requirements:

  • Controls of Critical Steps and Intermediates

  • Process Validation and/or Evaluation

  • Manufacturing Process Development

DRAP Requirements:

  • No information related to control of critical steps & intermediates, process validation, manufacturing process development etc.


Active pharmaceutical ingredient8

Active Pharmaceutical ingredient

WHO Requirements:

  • Characterisation

  • Elucidation of Structure and other Characteristics by IR, NMR or Mass spectroscopy.

  • Control of the API

  • Specification

    (API Specs of FPP manufacturer)

DRAP Requirements:

  • No characterization data required as elucidation of structure, control of APIs, Analytical procedures, validation of analytical procedures etc.


Active pharmaceutical ingredient9

Active Pharmaceutical ingredient

WHO Requirements:

  • Validation of Analytical Procedure of API,

  • Validation of related substances, residual/impurities solvents of API

  • Batch Analyses of three consecutive batches

DRAP Requirements:

  • Analytical method validation or batch analysis is not required


Active pharmaceutical ingredient10

Active Pharmaceutical ingredient

WHO Requirements:

  • Justification of Specification

  • Source of primary reference standards and its link to secondary and working standard

  • Container Closure System

DRAP Requirements:

  • No such information regarding reference standard is required.


Active pharmaceutical ingredient11

Active Pharmaceutical ingredient

WHO Requirements:

  • Stability

  • Stability studies of 3 consecutive batches at acc./inter. & long term conditions, Stability Summary and Conclusions

  • Proposed storage statement and re-test period

DRAP Requirements:

  • Only stability of FPP is required. No information is required about stability of API(s)


Active pharmaceutical ingredient12

Active Pharmaceutical ingredient

WHO Requirements:

  • Post-approval Stability Protocol and Stability Commitment

  • Stability Data

  • Actual stability results

  • Summary of analytical procedures and validation

DRAP Requirements:

  • No stability data is required for API.


  • Login