Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR COSMETIC 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 Cosmetic 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 NN before manufacture/production of SCD
the product.
Note: Evaluation to Approval/Denial takes 14 working days or
more depending on product evaluation

References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,

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

For RA:

Process / Requirement Source / Responsible Team

1. File for Addition of Source, adding or deleting the supplier, as RA
Amendment to the LTO. Amendment to the list of products
manufactured by Toll Manufacturer.
2. Apply for NN. RA
References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,
Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR COSMETIC PRODUCTS.

For R&D PD / PackDev:

Process / Requirement Source / Responsible Team

3. Prepare documents for NN.
a) Full ingredient Listing (using INCI names and in PD
decreasing order of composition in the formula),
indicating the percentage of any restricted ingredient
as per ACD
b) Scanned Copy of Clear and Complete loose labels or Pack Dev
artworks of all packaging sizes, including inner and
outer cartons, if any.

c) Technical Substantiation for claims: PD

i. Technical studies and reports

ii. Mechanism of actions for active ingredient with
claims
iii. COA and quantitative analysis and computations

References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,