SOP For Dossier Preparation

 SOP For dossier preparation is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

The SOP lays down the general guidelines for the preparation of the dossier for various ROW markets.

SCOPE

The guideline shall be applicable for preparation of dossier for ROW market.

RESPONSIBILITY

Officer Regulatory Affairs

ACCOUNTABILITY

Manager Regulatory Affairs

PROCEDURE

Dossier preparation activity shall start with receipt of the dossier request form (DRF) from marketing.

Coordinate with marketing for guidelines of the particular country where product shall be registered 

Confirm with R&D, QA and production about the formulation/specifications/process/method of Analysis etc.

Prepare the checklist according to the guidelines received from the official source

Status of documents shall be drawn as per checklist.

Quality related documents shall be obtained from R&D/QC/QA.

Clinical and Non-clinical documents shall be obtained from R&D.

Literature references shall be obtained from the internet.

Manufacture license and COPP shall be requested from liasioning department as per respective SOP.

Coordinate with packaging development department for preparation of artwork as per regulatory guidelines.

The open part of DMF shall be checked for product and if not available, coordinate with the purchasing department as per the respective SOP.

The documents shall be collected from:

Quality Documents: from R&D, CQA, QC and/ or site QA and

Clinical and Non-Clinical Documents: requested from R&D.

The adequacy of the document shall be checked as per regulatory requirement.

The document shall be returned to the concerned department for correction if any.

The Administrative Documents: i.e. GMP, Manufacturing License, Free sale certificate and/or COPP shall be collected from liasioning department.

After compilation, dossier shall be checked for correctness and completeness according to the check list and numbering the documents.

Finally, check the dossier for correctness and completeness.

After confirmation received from marketing, the documents will be sent to concerned agent and/ or client for registration.