SOP For New Product Introduction

1. OBJECTIVE :

The purpose of this SOP is to lay down the procedure for introduction of new product at the manufacturing location.

• SCOPE :

This SOP is applicable for all new products including exhibit and validation batches being taken for manufacturing facility.

• Responsibility:
  • Quality Control:
    • Prepare and send the Specifications, Standard Test Procedures and Method of Analysis to QA.
    • Coordinate with Production, QA, and Engineering for new requirements in terms of facility/equipment.
    • Perform the stability studies as per approved protocol.
    • Provide necessary support for analysis.
    • Coordinate with QA and Production for process validation.
  • Production:
    • To provide the facility for manufacturing the product.
  • Quality Assurance:
    • Execute process validation protocol and compile the report.
    • Introduce and maintain all new products, exhibit and validations at manufacturing site.
  • Engineering:
    • Provide necessary support for the maintenance of GMP area and plant machineries / equipments.

•    Procedure:
  1. New  products developed at Manufacturing site:
     1. A change control shall be initiated by Quality Assurance department for any new product that shall be planned / proposed to be introduced at the manufacturing site.
     2. Introduction of a new product at a location is decided by Marketing Department in coordination with Top Management, Quality Assurance and Regulatory Affairs.
     3. Quality Assurance shall receive Technical Details about the product from Quality Control for obtaining manufacturing license from State FDA. On receipt of Technical Details, designated person from the location shall apply and obtain the manufacturing license from State FDA.
     4. After receipt of all the technical information and docket, Quality Assurance department initiate to check and review the feasibility and availability of resources in different relevant departments with respect to new product as per Annexure-I.
     5. Production in coordination with engineering, shall arrange for the procurement of machine change parts / tooling, as required.
     6. Quality Control shall arrange for the chemicals, working standards, HPLC columns etc. required for the analysis as per the test procedures. If a specific test cannot be performed in-house, Quality Control shall evaluate the possibility of analyzing the same in approved Contract Testing Laboratory.
     7. If manufacturing technology requires creation/up-gradation of existing manufacturing facility, the same shall be discussed amongst all department heads and top management.
     8. Based on the requirement of the product, Production shall propose for the new machines/change parts required. Head Production shall evaluate the same and arrange for the procurement of machines/change parts.
     9. After receipt of the requisite, the same shall be installed and qualified. Necessary Standard Operating Procedures shall be made for operation and cleaning.
  2. • QA and / or Purchase shall qualify / validate the new vendors of the raw materials / packaging materials.
     • Regulatory Department shall prepare the artworks of printed components in coordination with Marketing department, Packaging Material section of Quality Control, and Regulatory Department and circulate the same for approval from Quality Assurance and record the technical information.
     • Purchase in coordination with QA shall arrange for the procurement of the raw materials and packaging materials from the approved vendors for the manufacturing of the product.
     • After receipt of the materials at the manufacturing location, the same shall be received by warehouse and the Goods Receipt Note shall be made. Materials shall be handled as per the procedure.
     • Quality Control Personnel shall sample the materials for testing as per the approved specifications and MOA and log the technical and analytical information.
     • Quality Assurance shall receive Technology Transfer Dossier from QC. Based on the Technology Transfer Dossier; Quality Assurance shall prepare Batch Manufacturing Record / Batch Packaging Record in coordinate with Production.
     • QA shall update the cleaning validation matrix based on the machines to be used for manufacturing and perform the cleaning validation as per the requirement. Analytical Department shall provide the necessary analytical testing procedures for the same.
  3. • A protocol bound process validation activity shall be done by Production, Quality Control and Quality Assurance.
     • The batches shall be subjected to protocol bound stability studies as per the Quality Control SOP. The responsibility for the stability study and reporting results lies with the QC.
     • On receipt of regulatory approval as the case may be, production/QA shall support the manufacturing locations in taking the first commercial batches.
  4. • Summary of the various steps in new product introduction is given in Annexure – I.

• Products Undergoing Site Transfers:Products to be manufactured on Contract basis for other companies for which technology is to be received from other manufacturers.Head QA of both the transferring and receiving locations shall carry out the technology transfer from one location to another.All the relevant steps required from 4.1.1 to 4.1.22 shall be followed.Depending on the product complexity, production shall take the support from QC.Head QA shall ensure that manufacturing activity shall be carried out at the manufacturing site after execution of Annexure –I by relevant department and final satisfactory comment shall be incorporated by QA with signature and date in annexure -I with respect to new product introduction.

• TRAINING:

                        Trainer                         : Head – Quality Assurance

                        Trainees                       : All Departmental / Sectional Heads

• DISTRIBUTION:

               Controlled Copy No.1         :  Head of Department – Quality Assurance

               Controlled Copy No.2         :  Head of Department – Production

               Controlled Copy No.3         :  Head of Department – Quality Control

                        Controlled Copy No.4            :  Head of Department – Warehouse / Stores

               Controlled Copy No.5         :  Head of Department – Microbiology

Original Copy                      :  Head – Quality Assurance

• ANNEXURE:

Annexure-I               :           Checklist for new product introduction

• REFERENCES:

Nil

• REVISION HISTORY:

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP