12

TECHNOLOGY AND LIVELIHOOD EDUCATION

AGRI-FISHERY ARTS – FOOD PROCESSING
QUARTER 3
WEEK 8

CapSLET
Capsulized
Self - Learning
Empowerment
Toolkit
Schools Division Office of Zamboanga City
Region IX, Zamboanga Peninsula
Zamboanga City
 CapSLET
Capsulized Self - Learning Empowerment Toolkit

SUBJECT &
TLE 12 QUARTER 3 WEEK 8
GRADE/LEVEL
Selection and checking of raw materials, products and/or supplies inclusive of travel
TOPIC
documents and permits
LEARNING Select and check raw materials, products and/or CODE
COMPETENCY supplies for ability to travel in accordance with
relevant regulations/permit requirements TLE_AFFP9- 12LD-IVi-j-3
a). list the document for raw materials, products and supplies inclusive of travels
and permit.
b). explain the requirements in selecting and checking raw materials, supplies
LEARNING
and products;
OBJECTIVES
c). design a graphic organizer for licensing procedure in raw material, supplies
and product;

IMPORTANT: Do not write anything on this material. Write your answers on the learner’s activity and
assessment sheets provided separately.

UNDERSTAND
Let’s have a simple understanding about the topic today .
MANUFACTURER
means an establishment engaged in any and all operations involved in the production of health products
including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting,
finishing and labeling with the end in view of its storage, sale or distribution. A trader shall be categorized a
manufacturer.
TRADER
means any establishment which is a registered owner of a health product and procures the raw materials and
packing components and provides the production monographs, quality control standards and procedures, but
subcontract the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage
in the distribution and/or marketing of its products.

Manufacturing Process

The same process can apply for traders, with the

exemption of the production process that is
subcontracted to a manufacturer.
The coverage of the contract between a trader
and a manufacturer vary, depending on the
agreement between the two establishments.

Quality System Operational Requirements

Documentation
Personnel These are the key areas that a manufacturer needs to establish and
Premise maintain for its operation.
Equipment
Sanitation and Hygiene The FDA shall be issuing a detailed guideline for all areas and shall be
Production discussed during the QPIRA Seminar
Quality Control

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 QUALITY SYSTEM

❖ A comprehensively designed and correctly implemented

system to ensure the attainment of the company’s
objectives
❖ A company’s quality system must be appropriate for its
current activity Quality Manual Quality Procedures Work
Instructions Records
❖ The company must at least establish its quality manual,
organizational structure, procedures, controls, work
instructions, forms, and other records.

DOCUMENTATION
Site Master File A document providing a general overview of the structure and activities of the
manufacturer.
Raw Material Specifications Describe in detail the requirements with which the materials used or obtained
during manufacture have to conform. They serve as a basis for quality
evaluation.
Master Formula, This contains all information about the manufacturing process for the product
Procedures, and Standards and the expected output. This document is kept and controlled by the QA
personnel.
Standard Operating Written instructions of the performance of specific activities.
Procedures

Records Provide evidence of various actions taken to demonstrate compliance with

instructions, e.g. activities, events, investigations, and in the case of
manufactured batches a history of each batch of product, including its
distribution. Records include the raw data which is used to generate other
records. For electronic records regulated users should define which data are
to be used as raw data. At least, all data on which quality decisions are based
should be defined as raw data
DOCUMENTATION
SITE MASTER FILE IV. Premise and Equipment
I. Table of Contents ▪ General Location of Site
II. Company Overview ▪ Detailed Site Layout (with dimensions)
▪ General Information ▪ Personnel, Material, and Product Flow
▪ Site Overview ▪ List of Manufacturing Equipment
▪ Products Produced ▪ Maintenance and Calibration
III. Personnel V. Documentation
▪ Organizational Chart ▪ SOPs and Forms
▪ Employees with Job Description VI. Contract Manufacturing and Analysis
▪ Training Requirements Health and Hygiene ▪ Toll Manufactured Products
Requirements ▪ Analysis Contracted Out
VII. Internal Quality Audit and FDA Reporting and
Inspection
▪ Inspections Conducted
▪ Compliance History
Standard Operating Procedures
• Training of personnel  Storage
• Handling of Raw Materials  Checking
 Acceptance of Incoming  Storage
 Dispensing • Batch Numbering System
 Disposal of Expired & Reject • Handling of Finished Products
• Handling of Raw Materials  Approval and Release
 Acceptance of Incoming  Returned, Expired & Reject
 Dispensing • Storage
 Expired & Reject  Raw Materials
• Production Procedure  Finished Products
 Pre-production preparation • Distribution of Finished Products
 Dispensing • Handling of Complaints
 Mixing • Product Recall
 Packaging & Labelling • Laboratory Analysis of Finished Products
 Checking • Records Keeping

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 BATCH MANUFACTURING RECORD
PRODUCT PACKAGING AND LABELING
Primary Packaging Secondary Packaging
❖ shall mean any
material, including printed
material, employed in the
packaging of product,
excluding any outer
packaging used for
transportation or
shipment, that is in direct
contact with the electronic
cigarette refill solution
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❖ shall mean any material,
including printed material,
employed in the packaging
of product, excluding any
outer packaging used for
transportation or shipment,
that is not in direct contact
with the electronic cigarette
refill solution (e.g. product
inserts, tags, etc.)
 LABELING REQUIREMENTS

Restrictions Samples of Restricted Content

All Health Claims Smoking Cessation Claims
Harm Reduction Claims
Terms such as:
1. Light; Lites; Ultra lite
2. Supreme
3. No.1 4. Leading
5. Most
6. Finest
Explicit/Implicit Conveyance of FDA Endorsement Terms such as:
1. FDA-approved
2. Any mention of FDA or
3. Any mention of Philippine FDA
4. Any imitation of such words and initials
FDA Logo
Any imitation of the FDA Logo

PRIMARY LABELING REQUIREMENTS

Article Required
1. The declared commercial name of the product (transliterated into the English alphabet)
a. Brand name
b. Name of Product Variant
2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable, to describe
the product.
3. The exact statement, “Keep out of the reach of children.”
4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL. (e.g. 10.0 mL)
5. Nicotine concentration expressed in mg/mL nicotine or the words “nicotine-free,” as applicable,
rounded to the nearest one mg/mL.
6. Batch/Lot number(s)
7. Expiry date 8. FDA Electronic Registration Number

SECONDARY LABELING REQUIREMENTS

1. The declared commercial name of the product (transliterated into the English alphabet)
a) Brand name
b)Name of Product Variant
2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable, to describe the
product.
3. Nicotine concentration expressed in mg/mL or the words “nicotine-free,” as applicable
4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL.
5. Marketing Authorization Holder Information
a) Company Name
b) Company Address
c) Company Contact Details
d) LTO Number
6. Country of Origin
7. List of ingredients contained in the product, in
descending order of concentration, with potential
allergens emphasized in bold characters. The declaration
should follow the succeeding format, inclusive of the
Chemical Abstracts Service Registry Number [CAS No.]:

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 8. FDA Electronic Registration Number
9. Instructions on the handling, use, and storage of the ENDS/ENNDS solutions
10. Usage cases to be avoided (in the context of current medications, health conditions, and interactions with
other drugs and other substances)
11. Instructions for the disposal of the ENDS/ENNDS solutions and container
12. Directions in case of ingestion or skin contact
13. GHS Pictogram, Signal Word, and Hazard Statement
14. Undesirable adverse health effects
15. Warning statements: a) Do not swallow b) Keep out of the reach of children c) Avoid prolonged contact
with the skin d) Nicotine is an addictive substance. e) Not suitable for pregnant women, nursing mothers,
children, persons with respiratory or cardiovascular diseases. f) Call the poison center or the hospital near
you in case of accidents, injury, or illness arising from the use of this product.
16. The updated contact information of University of the Philippines, National Poison Control and Information
Service, as of the time of manufacture
17. The exact statement: “For any complaints or reports on product quality and safety, please contact the
Food and Drug Administration by email: ccrr@fda.gov.ph.”
LICENSING PROCEDURE
1. Request for a user account by going to this link and accomplishing the online form: •
https://eportal2.fda.gov.ph/syseportal/en/neoclassic/2025723735d4504e361dde4030330943/2656580155d4641ea8a
a1d 9091841768.php

LICENSING PROCEDURE

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 SAQ-1Why there’s a need to select and check the document in raw materials, products and supplies
or products travel?

SAQ-2 What do you think will happen if you don’t have permit to your product?

Let’s Practice!
Directions: Fill out the table below. list the document needed for raw materials, products.

DOCUMENTS
1
2
3
4
5

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 REMEMBER

Key Points

PRIMARY LABELING REQUIREMENTS

Article Required
1. The declared commercial name of the product (transliterated into the English alphabet)
a. Brand name
b. Name of Product Variant
2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable, to describe
the product.
3. The exact statement, “Keep out of the reach of children.”
4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL. (e.g. 10.0 mL)
5. Nicotine concentration expressed in mg/mL nicotine or the words “nicotine-free,” as applicable,
rounded to the nearest one mg/mL.
6. Batch/Lot number(s)
7. Expiry date 8. FDA Electronic Registration Number

SECONDARY LABELING REQUIREMENTS

1. The declared commercial name of the product (transliterated into the English alphabet)
a) Brand name
b)Name of Product Variant
2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable, to describe the product.
3. Nicotine concentration expressed in mg/mL or the words “nicotine-free,” as applicable
4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL.
5. Marketing Authorization Holder Information
a) Company Name
b) Company Address
c) Company Contact Details
d) LTO Number
6. Country of Origin
7. List of ingredients contained in the product, in
descending order of concentration, with potential
allergens emphasized in bold characters. The declaration
should follow the succeeding format, inclusive of the
Chemical Abstracts Service Registry Number [CAS No.]:

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 TRY
Directions: design a graphic organizer for licensing
procedure in raw material, supplies and product. Criteria
Critical understanding of the material 20
Creativity 25
Content (correct information ,grammar) 25
Ability to anticipate objections 15
Total 15

REFERENCE/S Amsbary, R. (2013, June 12). Raw Materials: Selection, Specifications, and Certificate of
Analysis. Quality Assurance & Food Safety. https://www.fda.gov.ph/wp-
content/uploads/2019/09/Guidelines-for-Manufacturers-and-Traders.pdf
This learning resource contains copyrighted materials. The use of which has not been
specifically authorized by the copyright owner. We are making this learning resource in
our efforts to provide printed and e-copy learning resources available for the learners in
DISCLAIMER reference to the learning continuity plan of this division in this time of pandemic.
This LR is produced and distributed locally without profit and will be used for educational
purposes only. No malicious infringement is intended by the writer. Credits and respect to
the original creator/owner of the materials found in this learning resource.

Developed by:
MARIA FHARRA F. KABAYAO
Teacher I
Tagasilay National High School

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