Organizing Registration Folders

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It is important that the Registration SO Folders are organized consistently between all registrations so that all different departments will be able to locate and refer to the documents related to a registration. A registration is a long ongoing project that may involve multiple departments and more than a year to complete with revisions during this time.

This reference SOP briefly shows an example of a template of a registration folder, as well as other folders where Vendor and Customer related documents may also be saved in relation to that registration.

No. 1-3 below are documents related to Vendor, Customer or Agent, that may want to be saved not specifically in a registration folder as they are not to be revised and submitted to the MOH for registration, but rather purely for reference purposes.

No. 4 below is how documents specifically related to documents to be revised and submitted to the MOH are organized.

1) Vendor Related Documents

Example: VRA, CPA, Vendor PO, etc.

China - Distributor Folder → Registration Folder → Documents from Factory
Location: Z:\Shared drives\AdvaCare Distributors Control[Distributor Folder]\DOCUMENTS FROM FACTORY

India - India Registration → SO# Folder → Documents from Manufacturer
Location: Z:\Shared drives\AdvaCare Purchase India Control\AdvaCare Purchasing\Registration[SOXXXX Registration Folder]\DOCUMENTS FROM MANUFACTURER

2) Customer Related Documents

Example: Registration Guideline, Application Form and other templates

Distributor Folder → Registration Documents → Registration Information from Client
Location: Z:\Shared drives\AdvaCare Distributors Control[Distributor Folder]\REGISTRATION DOCUMENTS\Registration Information from Client

3) Documents from Agent

Example: CTD Dossier, BE Studies, DMF, etc.
Location: Z:\Shared drives\AdvaCare Cloud Server\Products\Dossiers

4) Registration Documents

Location:
China - Distributor Folder → Registration Documents → SO# Folder
Location: Z:\Shared drives\AdvaCare Distributors Control[Distributor Folder][SOXXXX]

India - India Registration → SO# Folder → REGISTRATION DOCUMENTS
Location: Z:\Shared drives\AdvaCare Purchase India Control\AdvaCare Purchasing\Registration\SO1113 - UNP - Kosovo - Vina\REGISTRATION DOCUMENTS

Structure of the folder must be followed as below:

a) Documents from Agent

Document received from Agent before any revisions.

b) Documents from Factory

Document received from Vendor before any revisions. Create sub-folders if registration has more than 1 Vendor.

i) Vendor A Name
ii) Vendor B Name
iii) Vendor B Name
b) FINAL

All documents ready to be sent for submission. Vendor and product documents, if there are more than 1 Vendor and/or 1 Products must be placed in sub-folders. General documents that only have 1 copy per registration can be saved in this folder as is.

i) Vendor A (site documents within here)
1) Product A
2) Product B
ii) Vendor B
1) Product C
2) Product D
iii) Vendor C

(if only 1 product, no need to create subfolders)

iv) Authentication (Legalization/Notarization)

Documents to be authenticated and scanned copies of documents already authenticated.

v) Reply to Queries (date) →

While working on query replies, documents can be saved here. Once documents are confirmed, the files must go to relevant folders (factory or product folders) while the old versions are then moved to the “Old” folders). If they are new documents that were added afterwards, keep them here.

*The different levels are applicable if there are multiple factories/products, if not applicable, no need.

d) Information for Agent

Filled in templates and other documents to be provided to the agent.

e) Registration Information from Client

Information provided by the Customer for this registration including guidelines and templates for easy access.

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