UNIT 3.pptx

WHAT DO U PREPARED FROM THIS ……
1.QA
2.QC
3.DIFFRENCE BETWEEN QA & QC

18
•The quality of the packaging of
pharmaceutical products plays a very
important role in the quality products.
•According to USFDA - A container
closure system refers to the sum of
packaging components that together
contain and protect the dosage form.

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Container is one in which the product
is placed or a device that holds the
drugs and is or may be in direct
contact with the preparation

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Container is one in which the product
is placed or a device that holds the
drugs and is or may be in direct
contact with the preparation

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Closure are the devices by means of
which container can be opened or
closed

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Closure are the devices by means of
which container can be opened or
closed

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ROLE OF PACKAGING:
PROTECTION
PRESENTATION
IDENTIFICATION
INFORMATION
COMPATIBLE
CONVENIENCE

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ROLE OF PACKAGING:
PROTECTION
PRESENTATION
IDENTIFICATION
INFORMATION
COMPATIBLE
CONVENIENCE

26
REQUIREMENTS OF GOOD PACKAGING:
•The packaging itself does not have an adverse effect on the
product (e.g. through chemical reactions, leaching of
packaging materials or absorption).
•The product does not have an adverse effect on the
packaging.
•They must protect the preparation from environmental
conditions
•The resulting requirements must be met throughout the
whole of the Intended shelf-life of the product.

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REQUIREMENTS OF GOOD PACKAGING:
•They must not be reactive with the product.
•They must not impart to the product tastes or odors.
•They must be nontoxic.
•They must be FDA approved.
•They must meet applicable tamper-resistance requirements.
•They must be adaptable to commonly employed high speed
packaging equipment.

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● Protect against all adverse external influences that can
alter the
● Properties of the product, e.g. moisture, light, oxygen
and temperature and variations;
● Protect against biological contamination;
● Protect against physical damage;
● Carry the correct information and identification of the
product.

QUALITY CONTROL TESTING
OF CONTAINER

33
Packaging may be defined as the art and science
which involves preparing the articles for transport,
storage display and use.
Pharmaceutical packaging is the means of providing
protection, presentation, identification, information
and convenience to encourage compliance with a
course of therapy.

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Packaging may be defined as the art and science
which involves preparing the articles for transport,
storage display and use.
Pharmaceutical packaging is the means of providing
protection, presentation, identification, information
and convenience to encourage compliance with a
course of therapy.

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Composition of package:
(a) Container
(b) Closure
(c)Carton or Outer
(d) Box

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(a) Container
(b) Closure
(c)Carton or Outer
(d) Box

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(a) Container
(b) Closure
(c)Carton or Outer
(d) Box

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(a) Container
(b) Closure
(c)Carton
(d) Box

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(a) Container
(b) Closure
(c)Carton or Outer
(d) Box

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Based on the utility for different pharmaceutical doses
forms, containers are divided as following.
1. Well closed Containers
⏺Protects the content from loss due to
transportation, handling, sale and Storage.

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2. Air-tight containers
⏺Also called hermetic containers.
⏺These have air-tight sealings or closings to avoid
air contact.
⏺Protect the product from dust, moisture and air.
Air-tight sealed containers are used for injectables. Air-tight closed
containers are used for other products i.e thyroxine tablets.

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3. Tightly-closed containers:
⏺These containers are capable of being tightly re-closed after
use i.e. gas cylinder, which is a metallic tightly-closed container
and holds gas under pressure.
⏺Protects the contents from contamination by liquids, solids or
vapours, from loss or deterioration of the material from
effervescence, deliquescence, or evaporation under normal
condition of handling, storage and distribution.

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4. Single dose containers:
⏺Single dose containers are generally used to hold
parenteral products (injectables) i.e. ampoules and
vials.
⏺single dose containers are used to supply only one
dose of medicaments.

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5. Multi-dose containers :
⏺Hold more than one dose and allow withdrawal of
dose at various intervals without changing the
strength, quality, and purity of the remaining portion.
⏺Multi-dose containers are used for injectables i.e.
ampoules.

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6. Light-resistant containers:
⏺ Protect the medicaments from the harmful
effect of light.
⏺These are used to store medicaments which are
photo-sensitive.

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7. Aerosol containers
⏺ Used to hold aerosol products.
⏺These containers should have adequate
mechanical strength in order to bear the
pressure of aerosol packaging.

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8. Temper evident containers
⏺These Containers are fitted with a device or
mechanism which irreversibly reveals whether
the container is opened or closed.

Define Packaging Material
Types Of Packaging Material
Types Of Container

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(C) HYDROLYTIC RESISTANCE OF GLASS CONTAINER:

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(D) ARSENIC TEST: ➢This test is for glass
container intended for aqueous parenteral.
➢Wash the inner and outer surface of container
with fresh distilled water for 5min

QC OF GLASS CONTAINER

Quality control test for
Plastic Container

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•Plastic containers for pharmaceutical products
are made from plastics based on the following
polymers: polyethylene (low or high density),
polypropylene, polyvinyl chloride, polystyrene .
•The containers consist of one or more polymers
together with certain additives if necessary.
•Additives may consist of antioxidants,
lubricants, plasticizers and impact modifiers.

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Drug Plastic Consideration
Permeation
Leaching
Sorption
Chemical Reactivity

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Drug Plastic Consideration
Permeation
Leaching
Sorption
Chemical Reactivity

PARENTERAL AND
NON-PARENTERAL PREPARATIONS

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PLASTIC CONTAINERS FOR OPHTHALMIC
PREPARATIONS:-
Plastic containers for ophthalmic preparations comply with the
following tests:
1 Leakage test; Collapsibility test Clarity of aqueous extract; Non-
volatile residue
Comply with the tests described under Plastic containers for Non-
parenteral Preparations.
2 Systemic injection test; Intracutaneous test Comply with the tests
described under Plastic containers for Parenteral Preparations.
3 Eye irritation test. This test is designed to evaluate responses to
the instillation of extracts of material under examination in the eye
of a rabbit.

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•Metals have a number of advantages over
other packaging materials.
• Like glass, metal is nearly totally
impermeable to gas and water.
•In addition, metal containers are extremely
strong

INTRODUCTION
• GLP is an FDA regulation.
• GLP is a formal regulation that was created by the
FDA (United states food and drug administration) in
1978.

Purpose of GLP
Good laboratory practice (GLP) :
To promote the development of
quality and validity of test data
used for determining the safety of
chemicals, Pharmaceuticals, Food,
Cosmetics etc.

◎ Reporting of Study Results •
Information on sponsor and
test facility. • Experimental
starting and completion dates. •
A Quality Assurance Program
Statement. • Description of
materials and test methods. •
Results. • Storage (samples,
reference items, raw data, final

Storage and Retention of Records and Materials –
◎ The study plan, raw data,
samples. – Inspection data and
master schedules. – SOPs. –
Maintenance and calibration
data. – If any study material is
disposed of before expiry the
reason to be justified and
documented. – Index of
materials retained

UNIT 3.pptx

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UNIT 3.pptx