The FDA requires that all primary and secondary packaging materials be suitable for their intended use. “Suitable for intended use” means that the packaging should not only protect the product’s form of dosage, but also be compatible with that dosage form. It’s also required that primary and secondary packaging be made of a material that’s considered safe to use, both with the product’s administration route and its form of dosage.

1. Pharmaceutical Product Development
Guidelines for Pharmaceutical Packaging and Labeling
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Primary
Packaging
Guideline
Secondary
Packaging
Guideline
Labelling
Guideline

3. Introduction
As a business that sells pharmaceutical products, it’s
absolutely critical to understand the guidelines that govern
the labeling and packaging of those products.
The Food and Drug Administration is the regulator of labeling
standards, and you’ll learn about their requirements for
proper pharma packaging and labeling, as well as where to
go for quality labeling solutions.
Packaging Design Guidelines
» Primary Packaging
» Secondary Packaging

4. Primary packaging is any that comes into direct contact with a pharmaceutical, such
as a blister pack or pre-filled syringe.
Secondary packaging is that which doesn’t come into direct contact with a product
and would include a carton or an accessory like a syringe plunger rod.
The FDA requires that all primary and secondary packaging materials be suitable for
their intended use. “Suitable for intended use” means that the packaging should not
only protect the product’s form of dosage, but also be compatible with that dosage
form.
It’s also required that primary and secondary packaging be made of a material that’s
considered safe to use, both with the product’s administration route and its form of
dosage.
Packaging Design Guideline

5. Primary packaging of pharmaceuticals should protect products from degradation and
subsequent loss of efficacy due to:
► Microbial Contamination
► Exposure to Light
► Oxidation
Primary packaging is also not permitted to interact with the product in any way that
would alter its or its packaging’s essential properties, or release carcinogenic or
mutagenic substances into the product.
Primary Packaging

6. The secondary packaging of any product should serve at least one of the following. It
should provide:
 Light protection for the system of packaging
 Protection for any excessive emission of reactive gas in or out of the packaging system
 Protection from microbial intrusion
 Protection from excessive moisture or solvent transmission in or out of the packaging
system
 Protect packaging systems needing additional handling protection or those which are
flexible
Secondary Packaging

7. Label printing for pharmaceutical use is required by the FDA to be designed and
applied in such a way that it can remain in place, and be legible in a number of
environments like use and storage for the entire lifespan of the product.
Label Contains -
→ Direction for use
→ Warnings
→ Active & inactive ingredients
→ Official product name
→ Dosage
The design of a label must be of a legible font type and size, be in appropriate
language and format, and be made of approved materials. All labels should be
thoroughly inspected to ensure accuracy and consistency of information.
Labelling Guidelines

8. THANKS!
Do you have any questions?
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