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Product Dossier Registration Process

Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. 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. This process is governed and permitted by Drug Regulatory Authority of a respective country.

Procedure for Product Dossier Registration

1.0   PURPOSE

    • The purpose of this Standard operating procedure (SOP) is to lays down the general guidelines for the document requirement for preparation of product dossier for various ROW markets.

2.0   SCOPE

    • The SOP shall be applicable for preparation of common technical documents (Product Dossier) at pharmaceutical drug manufacturing plant/corporate offices.

3.0   RESPONSIBILITY FOR PRODUCT DOSSIER REGISTRATION

    • Regulatory Affairs/Export Department shall be Responsible for;

    • Initiation of requirement.Product Dossier Registration
    • Prepare the Product Dossier (CTD).
    • Coordination with various stakeholders for completion of activities.
    • Review of the product dossier (CTD) for adequacy before submission.
    • Final Approval & submission of product dossier.

    • R&D /F&D shall be Responsible for;

    • Provide the master technical documents (Manufacturing & Analytical).
    • Provide technical (analytical & manufacturing) support to respective site.
    • To arrange for CDP data in multimedia for certain molecules, based on biowaiver classification.
    • To prepare PDR.
    • Coordination with various stakeholders for completion of activities.

    • Quality Control shall be Responsible for;

    • Provide analytical service support as per requirement.
    • Ensure the Analytical method Validation availability.
    • Review & Approve the analytical documents as per specific product dossier requirement.
    • Coordination with various stakeholders for completion of activities

    • Quality Assurance shall be Responsible for;

    • Ensure the availability of Process validation & stability study of respective product.
    • Review & Approval of the manufacturing & analytical documents as per specific product dossier requirement.
    • Coordination with various stakeholders for completion of activities.

    • Location Manufacturing shall be Responsible for

    • Ensure the availability of the product manufacturing specific requirement at site.
    • Product batches being manufactured as per Process validation document.
    • Review & Approval of the manufacturing documents as per specific product dossier requirement.
    • Coordination with various stakeholders for completion of activities.

    • Location Warehouse shall be Responsible for

    • Ensure the availability of Raw & Packing materials of specific requirement at site.
    • Coordination with various stakeholders for completion of activities.

    • Packaging Development (exports) shall be Responsible for

    • Development and preparation of artwork as per regulatory guidelines or country requirement.
    • Provide the approved artwork to site.

4.0   PROCEDURE FOR DRUG PRODUCT DOSSIER REGISTRATION

    • Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. 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. This process is governed and permitted by Drug Regulatory Authority of a respective country.

    • GENERAL REQUIREMENT – INITIATION:

    • Product dossier (CTD) preparation activity shall start with receipt of complete details of respective product dossier from regulatory affairs department.
    • Regulatory affairs shall provide the product specific requirement and current guidelines of particular country where product shall be registered.
    • Regulatory affairs shall e Provide the detail information regarding product dossier & the specific list of dockets / Samples required to respective site.
    • 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  .
    • RA shall prepare the checklist according to the current guidelines of respective country. RA shares the checklist with concern location. Status of documents shall be drawn as per checklist.
    • Export / RA shall arrange for the DMF in co-ordination with planning
    • For arranging any additional information /details after evaluation by site, the same to be directly forwarded to concern stake holder and export/RA.

    • New codes (material, product etc.) generation shall be intimated to system team from end user & vice versa.

    • R&D/F&D shall start the working on new (product registration) requirement after obtaining complete information. Provide complete TTD to respective site as specific to dossier submission.
    • For products, wherein Validation data (dissolution/Related substances etc.) if not available, AR&D to develop the method and arrange for validation data.
    • R&D/F&D shall arrange for CDP data in multimedia for certain molecules, based on biowaiver classification.
    • R&D to arrange for the photostability data if required.
    • Regulatory affairs to select the product based on the requirement & to ensure that validation & stability batches are planned only after the finalization of the specification as per DMF/updated pharmacopeia.
    • Also all the required test parameters are available in specification & if some parameter is required to be developed then arrange for the same in coordination with R &D, before planning for validation /stability batches.
    • Exports and Planning dept. to ensure that the Raw materials (API /Excipients) & Packing materials as per applicable export specification (for API specific make in three different lots (batches) and excipients (non specific make) have been directly procured for validation & stability batches. Warehouse shall be coordinate with planning department for same.
    • RA/export shall arrange for the Innovator Samples for CDP if required.
    • Exports to arrange in co-ordination with planning dept. for the Pack Profile and packing material in case of new requirement i.e. where the required pack is not in existence.

    • GENERAL REQUIREMENT – EXECUTION METHODOLOGY:

    • Manufacturing site shall start execution on new (product registration) requirement once complete details, documents as per requirement obtained from respective stakeholder.
    • Site representatives (QA/QC/Production/warehouse) shall review adequacy of documents and requirement, if any query shall be intimated to respective concern with due intimation to export/RA.
    • Current regulatory  guideline  of  respective  country  shall  be  followed  with following considerations:
    • After the availability of API (make specific & in three lots) and excipients (directly procured as per export specification), Validation batches to be charged for stability as & when receipt of export order or from domestic planning (in case of similar formula & compliance of domestic product as per export specification).
    • RA will confirm the same. Further decision of annual batches /validation will be decided by QA based on data available at their end.
    • Stability Study – Real time condition: 25/60 condition. This is subject to product being offered in certain territories, such as CIS wherein we need to submit Zone II stability.
    • Raw material (API & excipient) procurement along with vendor COA shall be carried out as per required pharmacopeia status.
    • Raw materials (API & excipients) shall be analysed as per required pharmacopeia.

    • GENERAL REQUIREMENT – DOCUMENTATION:

    • Drug Product (Name, Dosage Form)
    • Pharmaceutical Development:-
    • PDR is required for all products as per CTD format.
    • This contains information on the development studies conducted to establish that the dosage form, the formulation, manufacturing process, container closure system, microbiological attributes and usage instructions that are appropriate for the purpose specified in the application.
    • Additionally, this section should identify and describe the formulation and process attributes (critical parameters) that can influence batch reproducibility, product performance and drug product quality.
    • Description and Composition of the Drug Product
    • Components of the Drug Product (Name, Dosage Form)
    • Drug Substance
    • Excipients
    • Drug Product
    • Formulation Development
    • Overages
    • Physicochemical and Biological Properties

    • Manufacturing Process Development

    • Container Closure System
    • Compatibility
    • Description of Manufacturing Process and Process Controls
    • Process Validation and/or Evaluation Report
    • Specifications and Analytical Procedures of Raw Materials
    • Specifications and Analytical Procedures of Drug Products
    • Certificate of Analysis, Batch Analyses Report
    • Characterization of Impurities
    • Reference Standards of Materials
    • Stability of drug product
    • Quality related document shall be obtained from R&D/ADL & QA/QC.
    • Clinical and Non-Clinical documents shall be obtained from F&D.
    • Manufacturing license and COPP documents shall be requested from location.
    • The document shall be collected from the respective department.
    • Adequacy of documents shall be checked by individual departments as per checklist & information provided by RA before sending to RA.
    • The document shall be returned to concerned department for correction, if any.
    • RA shall prepared and compilation of product dossier as per checklist of respective countries.
    • After compilation, dossier shall be checked for correctness and completeness.
    • Final complete product dossier shall be sent to concerned agent and/or client for registration respective country.

5.0   REFERENCES – DRUG PRODUCT DOSSIER REGISTRATION

    • CDSCO Guidelines for CTD
    • In-house

6.0   ABBREVIATIONS USED IN SOP FOR PRODUCT DOSSIER

    • CTD             :         Common Technical Document
    • CDP             :         Comparative Dissolution Profile
    • PDR             :         Pharmaceutical Development Report
    • SOP             :         Standard Operating Procedure
    • COA             :         Certificate of Analysis.
    • QC               :         Quality Control
    • QA               :         Quality Assurance
    • RM               :         Raw Material
    • PM               :         Packing Material
    • TTD              :         Technology Transfer Document
    • R&D             :         Research and Development
    • FR&D          :         Formulation Research and Development
    • AR&D          :         Analytical Research and Development
    • COPP           :         Certificate of Pharmaceutical Product
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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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