![]() ![]() New codes (material, product etc.) generation shall be intimated to system team from end user & vice versa.For arranging any additional information /details after evaluation by site, the same to be directly forwarded to concern stake holder and export/RA. ![]() Export / RA shall arrange for the DMF in co-ordination with planning.Status of documents shall be drawn as per checklist. RA shares the checklist with concern location. RA shall prepare the checklist according to the current guidelines of respective country.RA shall confirm with R&D/ F&D,QA/QC, Production about the technology transfer documents etc.- Applicable for new products developed at FR&D for Generic drug application as per Export requirements.Regulatory affairs shall e Provide the detail information regarding product dossier & the specific list of dockets / Samples required to respective site.Regulatory affairs shall provide the product specific requirement and current guidelines of particular country where product shall be registered.Product dossier (CTD) preparation activity shall start with receipt of complete details of respective product dossier from regulatory affairs department.This process is governed and permitted by Drug Regulatory Authority of a respective country. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non- clinical and clinical data. Product Dossier (CTD): Dossier is a collection of documents on the particular subjects.Development and preparation of artwork as per regulatory guidelines or country requirement.Ĥ.0 PROCEDURE FOR DRUG PRODUCT DOSSIER REGISTRATION.Packaging Development (exports) shall be Responsible for.Ensure the availability of Raw & Packing materials of specific requirement at site.Location Warehouse shall be Responsible for.Review & Approval of the manufacturing documents as per specific product dossier requirement.Product batches being manufactured as per Process validation document.Ensure the availability of the product manufacturing specific requirement at site.Location Manufacturing shall be Responsible for.Review & Approval of the manufacturing & analytical documents as per specific product dossier requirement.Ensure the availability of Process validation & stability study of respective product.Quality Assurance shall be Responsible for.Coordination with various stakeholders for completion of activities.Review & Approve the analytical documents as per specific product dossier requirement.Ensure the Analytical method Validation availability. ![]()
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