Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR FOOD 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 Food 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 2020-033, AO 2014-029,

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

For RA:

Process / Requirement Source / Responsible Team

8. File for Addition of Sources, adding or deleting the supplier, as RA
Amendment to the LTO
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 2020-033, AO 2014-029,
Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR FOOD PRODUCTS.

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

Process / Requirement Source / Responsible Team

11. Prepare documents for product registration or variation
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 (at least two different
perspective)
For Food Supplement: include artworks and/or blister
packs Alu-Alu pack and secondary packaging (i.e. paper
box or cardboard box)
b) Technical Substantiation for claims: PD
i. Technical or nutrition health studies or reports
ii. Market Research Studies
iii. COA and quantitative analysis and computations
iv. Certificates or certification to support use of
logo/seal on Sangkap Pinoy, Halal, Organic, Kosher, and
in compliance with current labelling requirements
c) Certificate of Analysis reflecting Critical Parameters: PD
- for Medium and High Risk Products with Standards of
Identity (infant formula, milk supplement, food for
infants and young children, foods for special medical
purposes, foods for special dietary use, food
supplement, bottle water, process meat products, etc.),
the corresponding COA for assessment of compliance
to such standard must be uploaded.
d) Additional Requirement for Food Supplement: PD
- Stability study of finished Product
- Safety Data (e.g. LD50 or toxicity tests as applicable to
products with herbs and botanical ingredients not
included in the Official Pharmacopoeias and Generally
Recognized as Safe (GRAS) list or other applicable test
procedures or reports to assess potential toxicity)
e) Technical Documents:
(a) Manufacturing Procedure with Flowchart TSD
(b) Formulation PD
(c) Product / FG Specification, including Micro 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
References: FDA Circular 2020-033, AO 2014-029,