1.0 PURPOSE
The SOP lays down the general guidelines for the preparation of the dossier for various ROW markets.2.0 SCOPE
The guideline shall be applicable for preparation of dossier for ROW market.3.0 RESPONSIBILITY
3.1 Officers/ Executive –Regulatory AffairsShall review the documents for adequacy and prepare the dossier for submission.
3.2 Asst. Manager/ Manager –Regulatory Affairs
Responsible for reviewing of dossier before submission.
4.0 ACCOUNTABILITY
4.1 Head Regulatory AffairsHead of Regulatory Affairs shall be responsible for approval of SOP.
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 the particular country where product shall be registered and/or shall get guidelines from the official web site 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 received from the official source and/ or from 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/ or site QA.
5.7.2 Clinical and Non-clinical documents shall be obtained from R&D.
5.7.3 Literature references shall be obtained from the internet.
5.8 Manufacture licence and COPP shall be requested from liasioning department as per respective SOP.
5.9 Co-ordinate with packaging development department for preparation of artwork as per regulatory guidelines or country requirement.
5.10 The open part of DMF shall be checked for product and if not available, co-ordinate for the same from the purchasing department as per the respective SOP.
5.11 The documents shall be collected from the respective department. For example Quality documents from R&D, CQA, QC and/ or site QA and Clinical and Non-clinical documents requested from R&D.
5.12 The adequacy of the document shall be checked as per regulatory requirement.
5.13 The document shall be returned to the concerned department for correction if any.
5.14 The administrative document i.e. GMP, Manufacturing Licence, Free sale certificate and/or COPP shall be collected from liasioning department.
5.15 Preparation and compilation of the dossier shall be started as per the checklist of respective countries.
5.16 After compilation, dossier shall be checked for correctness and completeness according to the check list and numbering the documents.
5.17 Finally, check the dossier for correctness and completeness.
5.18 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 procedure6.2 COPP: Certificate of pharmaceutical product
6.3 DRF: Dossier request form
6.4 DMF: Drug Master File
6.5 GMP: Good Manufacturing Practice
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