Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR HUHS PRODUCTS.

For SCD:

Process / Requirement Source / Responsible Team

1. Inform RA/R&D/QA of the planned change (Addition or SCD
Deletion) via email or Change Control, if applicable
2. Secure availability of the following documents from the new SCD
supplier /TPM:
 Copy of License to Operate (as HUHS Manufacturer)
 Copy of GMP Certification (as issued by PH FDA)

3. Accomplish Supplier Quality Audit. Secure copy of the audit SCD / QA

report for filing and future FDA inspection.
4. Inform supplier that the following must be complied prior to SCD
start of production of PC products:
 Amendment to their product listing under their LTO
adding the PC products to be manufactured. Secure a
copy once available.
 Amendment to the Client Listing, adding PC as one of
their Trader/Client/Distributor under their LTO. Secure
a Copy once available.
5. Secure availability of notarized SUPPLIER-PC AGREEMENT SCD
6. Add the Qualified Supplier to the Supplier Master List (update SCD
the Supplier Master List)
7. Wait for availability of CPR before manufacture/production of SCD
the product.
Note: Pre-assessment + Payment + Evaluation + Approval for
Food takes 40 to 114 working days

References: FDA Circular 2020-025

Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR HUHS PRODUCTS.

For RA:

Process / Requirement Source / Responsible Team

8. Apply for Variation. RA
9. Prepare documents for product registration or variation RA
application, as applicable. Apply for CPR.
10. Inform team once CPR is available RA
References: FDA Circular 2020-025
Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR HUHS PRODUCTS.

For R&D PD/ PackDev/ QA/ TSD:

Process / Requirement Source / Responsible Team

11. Prepare documents for product registration or variation RA
application, as applicable. The following documents are
required:
a) Scanned Copy of Clear and Complete loose labels or Pack Dev
artworks of all packaging sizes and picture of
product in all angles and in different sizes

b) Technical Substantiation for claims: PD

i. Technical studies or reports

ii. Literature review on published data of on the
properties of the ingredients contained in the HUHS
product
iii. Actual Tests Performed

c) Certificate of Analysis of the Finished Product PD

d) Safety Data Sheet (SDS) of the HUHS product (in PD

GHS Format)
e) Technical Documents:
(a) Manufacturing Procedure with Flowchart TSD
(b) Formulation PD
(c) Product / FG Specification PD
(d) RM Specification PD
(e) Packaging Specification Pack Dev
(f) Certificate of Packaging Suitability TSD / Pack Dev
(g) Test Methods with Results PD
(h) COA of product PD
(i) Shelf Life Study / Stability Study RA
(j) IPO Certificate, if any
12. Start PIF filing. PD/PackDev/QA/TSD/RA/SCD
References: FDA Circular 2020-025