Purpose

To describe the procedure of Technical feasibility study of drug product before commercialization.


Scope

This SOP is applicable to perform the Technical Feasibility study of new drug products.


Responsibilities

  • Project Management department is responsible to provide proposal from TSD to assigned scientists, FRD to perform the feasibility study.
  • Scientists, FRD are responsible to initiate the Technical Feasibility Study of assigned product.
  • Head of Department or his designee FRD, ARD, EHS, Compliance, Validation and Calibration, QC, Microbiology (if applicable), Production (Manufacturing and Packaging), Engineering and RA are responsible to assess the feasibility with respect to their own area.
  • Head of R&D or his designee is responsible to put his comment with conclusive recommendation/decision reviewing all the comments from other departments.
  • Head of QA or his designee is responsible to put his comment with conclusive recommendation/ decision reviewing all the comments from other departments.
  • Personnel of Project Management or Scientists, FRD are responsible to share the approved copy of Technical feasibility study with TSD and DQA.
  • QA/FRD is responsible to archive the approved copy of Technical Feasibility Study documents.


Abbreviations

  • FRD : Formulation Research and Development
  • ARD : Analytical Research and Development 
  • RA : Regulatory Affairs 
  • QC : Quality Control
  • QA : Quality Assurance
  • TSD : Technical Services Department 
  • EHS : Environmental Health and Safety 
  • API : Active Pharmaceuticals Ingredient
  • R&D : Research and Development


Procedure

  • FRD receive the intimation / New Product Proposal from TSD/Project Management, R&D.
  • FRD fill up the product information in a form (Appendix). 
  • FRD take the comment in the Appendix form all the respective departments.
  • FRD take the conclusive recommendations / decision from Head of R&D or his designee and Head of QA or his designee in the Appendix.
  • Project Management/FRD send the Technical Feasibility Study Form (Appendix) with TSD and QA.
  • QA archive the approved Technical Feasibility Study Form (Appendix).

Content of Appendix

  • API nature (toxicity, stability, storage condition, MSDS etc.)
  • Target product information
  • Existing facility (production & qc) sufficient or not
  • Special facility require or not
  • Analytical equipment and reagents require or not
  • Development instruments available or not
  • R&D comment
  • Production comment
  • Regulatory comment