Checking and Revising Product Documents

| 3 minutes

When a Product Document has been received, the information of the documents must be checked. The objectives of checking and revising documents are:

• To ensure product description of the document are correct as per the product intended to be registered
• Valid: the certificate is not already expired
• Accurate: the information on the documents are accurate to prevent further queries from the MOH

Checking Product Certificates

Product certificates can be checked quickly, therefore as soon as they are received, it is best to give it a quick check and to inform the Vendor/Purchasing Dept. (India) if there are any mistakes that need to be revised. Some examples for product certificates include: COPP, FSC, COA.

The important parts in checking product certificates include:

• Product Name and Specifications
• Vendor Name and Address
• Validity Period

Checking Customer Guideline/Template

Dossiers normally will take some time to check and revise. Before starting with any revisions, it is best to check the overall template of the dossier first to make sure that Vendor/Agent has provided the dossier as per the required template. If no guidelines/templates are provided, this part can be skipped.

Adding AdvaCare Information

Normally the parts that need to be revised in a dossier include:

• Product Brand Name
• Cover Page
• Applicant Information/MAH on different parts of the dossier
• Cover Letter and Application Form

Cover Letter and 1st page of the Application Form can be exported from the PR page of the product with these steps.

1. Open the PR Page.
2. Click “Print” on the top of the page.
3. Click on the documents to be exported from the dropdown.
4. The document will be downloaded to the “Downloads” folder, revise the document as required and insert into the dossier.
Note: each registration may have different requirements of the applicant information. Generally, the applicant is AdvaCare International Limited. But this may vary case by case, for existing Customers, make sure to check their previous product dossiers and keep the applicant consistent.

The standard applicant information is as follows:

ADVACARE INTERNATIONAL LIMITED
3/F, Jonsim Place, 228 Queen’s Road East, Wanchai, Hong Kong

Checking Key Information on the Dossier

Dossier contains a lot of information about a product. When checking a dossier, start with:

1. Prepare a Note saved in the Final folder, in case any deficiencies or revisions are needed to complete the dossier.
2. Making sure that each part of a module is filled in as required. If “Attached” or “Enclosed” is mentioned, make sure the attachment is a part of the dossier. If attachments are provided separately, add them into the dossier.
3. Extract pages for documents that need to be tracked separately as per the RA. Save these extracted documents in the Final folder with the correct names as well.
4. Check the Batch Formulation, Specifications, COA, Stability Studies to make sure that the information provided is correct.
5. Take note of the proposed shelf life and storage conditions, cross check with the packaging artwork design in the PACKAGING DESIGN folder. If shelf life cannot be confirmed on the design, send a task to BD Salesperson to confirm with them if shelf life is NOT 3 years (36 months).
6. Once done, if there are queries/deficiencies, send a task to Purchasing Dept./Vendor to provide the required documents and set an activity to follow up on these requirements.

Product Document Completed

After a product document has been checked, revised and/or approved, RA Specialist must also complete the following:

• Save the final copy in the Registration SO Folder - Final.
• Mark the document status under each PR as “COMPLETE”.
• Update Registration Milestone REG: 11. Documents Completed.
• Send a task to BD Salesperson with the link to the completed documents folder.
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