by 1.0 PURPOSE
to lay down procedure for general guideline for the preparation of the dossier for various ROW markets.
2.0 SCOPE
The SOP shall be applicable for preparation of dossier for ROW markets.
3.0 RESPONSIBILITY
3.1 Preparation- (officers and executive- Regulatory Affairs).
3.2 Checking- (Assist Manager and Manager-Regulatory Affairs)
4.0 ACCOUNTABILITY
4.1 Head Regulatory Affairs
5.0 PROCEDURE
5.1 Dossier preparation activity shall start with receipt of the dossier request form (DRF) from marketing.
5.2 Co-ordinate with marketing for guidelines of particular country where product shall be registered or shall get guidelines from the official website of the country.
5.3 A team/ individual shall be assigned the project.
5.4 Confirm with R&D, QA and production about the formulation/specifications/process/method of Analysis etc.
5.5 Prepare the checklist according to the guidelines receive from the official source and/ or marketing.
5.6 Status of documents shall be drawn as per checklist.
5.7 Shall request only those documents with are not available with Regulatory to respective department.
5.7.1 Quality related documents shall be obtained from R&D, CQA, QC, and QA etc.
5.7.2 Clinical and Non-clinical documents shall be obtained from R&D.
5.7.3 Literature references shall be obtained from the official websites.
5.8 Manufacture license and COPP shall be requested from liasioninng department as per respective SOP.
5.9 Co-ordinate with packing development department for preparation of artwork as per regulatory guidelines of country requirement.
5.10 The open part of DMF shall be checked for product and if not available, co-ordiante for the same from the purchasing department as per the respective SOP.
5.11 The document shall be collected from the respective department .
5.12 The adequency of the document shall be checked as per regulatory requirement.
5.13 The administrative document i.e. GMP, Manufacturing License, Free sale certificate and /or COPP shall be collected from liasioning department.
5.14 Preparation and compilation of the dossier shall be started as per checklist of respective countries.
5.15 After compilation, dossier shall be checked for correctness and completeness according to the checklist and numbering the documents.
5.16 Finally, Check the dossier for correctness and completeness.
5.17 After confirmation received from marketing, the documents will be sent to concerned agent and/ or client for registration.
6.0 ABBREVIATIONS
6.1 SOP : Standard operating procedure
6.2 COPP : Certificate of pharmaceutical product
6.3 DRF : Dossier request form
6.4 GMP : Good Manufacturing Practice
6.5 DMF : Drug Master Plan
