This document discusses packaging, package evaluation, stability testing, and shelf life of pharmaceutical products. It defines packaging and describes its importance in protecting pharmaceuticals. Stability testing aims to provide evidence on how product quality varies over time under different environmental conditions to establish shelf life. The document outlines protocols for stability testing, including storage conditions, sampling time points, test parameters, and presentation of results. The goal of stability testing is to ensure products remain safe and effective until their expiration date.

1. Packaging, Package
Evaluation, Stability and
Shelf life
Introducted by: Mohammed Abdulmalek Hamood
Supervisor:
Prof. Abdulwali Al- Shargabi

2. WHAT IS PACKAGING?
• Packaging is defined as the collection of different
components which surround the pharmaceutical
product from the time of production until its use.

3. IMPORTANCE OF PACKAGING
• Protect against all adverse external influences
• That can alter the properties of the product.
• Protect against biological contamination.
• Protect against physical damage.
• Carry the correct information and identification of
the product.
• Tamper evident / Child resistance/ Anti
counterfeiting.

4. FUNCTIONS OF PACKAGING
• Containment
• Not to leak, nor allow diffusion and permeation
• Strong enough to hold the contents during handling
• Protection
• Light
• Moisture
• Oxygen
• Biological contamination
• Mechanical damage
• Counterfeiting

5. STABILITY TESTING
• The purpose of stability testing is to provide
evidence on how thequality of a FPP varies with
time under the influence of a variety
ofenvironmental conditions such as temperature,
humidity and lightand to establish a shelf-life for
the FPP, to determine the storageconditions and
the in -use stability
• Should be conducted on the dosage form packaged
in the containerclosure system proposed for
marketing (including, as appropriate, anysecondary
packaging and container label)

6. STABILITY STUDIES
• Ultimate proof of suitability of the container
closure system and thepackaging processes
established by full shelf life stability studies

7. STABILITY TESTING CONT.
• Stability testing of pharmaceutical products is a
complex set of procedures involving
• considerable cost, time consumption and scientific
expertise in order to build inquality, efficacy and
safety in a drug formulation.The most important
steps during the developmental stages include
pharmaceutical
• analysis and stability studies that are required to
determine and assure:the identity, potency and
purity of ingredients, as well as
thoseoftheformulated products

8. STABILITY TESTING CONT
• .
• Stability testing is termed as a complex process because
of involvement ofa variety of factors influencing the
stability of a pharmaceutical product.
• These factors include:
• Stability of the active ingredient(s);
• interaction between
activeinngredientsandexcipients,manufacturing process
followedtype of dosage form,container/closure system
used for packaging.
• Light, heat and moisture conditions encountered during
shipment,storage and handling.

9. STABILITY TESTING CONT
• .
• Stability testing is a routine procedure performed on
drug substancesand products and is employed at
various stages of the productdevelopment.
• In early stages, accelerated stability testing (at relatively
hightemperatures and/or humidity) is used in order to
determine the typeof degradation products which may
be found after long-term storage.
• Testing under less rigorous conditions i.e. those
recommended forlong-term shelf storage, at slightly
elevated temperatures is used todetermine a product's
shelf life and expiration dates.

10. AIM
• The major aim of pharmaceutical stability testing
is:
• To provide reasonable assurance that the products
will remain at anacceptable level of fitness/quality
throughout the period during which theyare in
market place available for supply to the patients.
• And will be fit for their consumption until the
patient uses the last unit ofthe product.

11. PROTOCOL FOR STABILITY
TESTING
• The protocol for stability testing is a pre-requisite for
starting stability testing and isnecessarily a written
document that describes the key components of a
regulatedand well-controlled stability study.
• Because the testing condition is based on inherent
stability of the compound, thetype of dosage form and
the proposed container-closure system, the
protocoldepends on the type of drug substance or the
product.
• In addition, the protocol can depend on whether the
drug is new or is already inthe market.
• The protocol should also reflect the regions where the
product is proposed to bemarketed.

12. PHARMACEUTICAL PACKAGE
STABILITY TESTING
• Compression Strength Testing: Packages behave
differently when exposed to compressive forces.
Ituses testing capabilities to apply compressive
forces to packages and products and provide
acomprehensive report with data on the strength
of a package.Distribution Simulation Testing:
Packages experience many different forces during
the shipping and
• distribution process. It is the product
manufacturer's responsibility to evaluate
• 5 document the

14. CLIMATIC ZONES FOR STABILITY
TESTING
• For the purpose of stability testing, the whole
world has been divided into
• four zones (I - IV) depending upon the
environmental conditions the
• pharmaceutical products are likely to be subjected
to during their storage.These conditions have been
derived on the basis of the mean annual
• temperature and relative humidity data in these
region

15. CONTAINERS AND CLOSURES
• The testing is done on the product in immediate
containers andclosures proposed for marketing.
• The packaging materials include aluminium strip
packs, blister packs,HDPE bottles etc.

16. ORIENTATION OF STORAGE OF
CONTAINERS
• Samples of the solutions, dispersed systems and
semi solid drugproducts for stability studies must
be kept upright and positionedeither inverted or on
the side to allow for full interaction of theproduct
with the container-closure.
• This orientation helps to determine whether the
contact betweenthe drug product or solvent and
the closure results in the extractionof chemical
substances from the closure components or
adsorptionof product components in to the
container-closure

17. SAMPLING TIME POINTS
• Frequency of testing should be such that it is
sufficient to establish the
• stability profile of the new drug substance.
• For products with a proposed shelf life of at least
12 months, the testingfrequency at the long-term
storage condition should be every 3 monthsover
the first year, every 6 months over the second year
and annuallythereafter throughout the proposed
shelf life expiration date.

19. TEST STORAGE CONDITIONS
• The storage conditions to be selected are based
upon
• the climatic zone in which the product is intended
to be
• marketed or for which the product is proposed to
be
• filed for regulatory approval.

21. TEST PARAMETERS
• The stability test protocol should define the test parameters that
would be usedfor evaluation of the stability samples.
• The tests that monitor the quality, purity, potency, and identity
which could beexpected to change upon storage are chosen as
stability tests.
• Therefore appearance, assay, degradation products, dissolution,
microbiologicaltesting, and moisture are standard tests
performed on stability test samples.
• Microbiological tests include sterility, preservative efficacy and
microbial countas applicable e.g. for liquid injectable
preparations.
• The batches used for stability study must meet all the testing
requirementsincluding heavy metals, residue on ignition, residual
solvents

22. PRESENTATION AND RECORDING OF
STABILITY DATA
• Stability data is recorded in an organized,
comprehensive andcumulative format.
• The stability data table is the means for reporting
the results of thestability study in a concise format
for ease of review andinterpretation.
• The data is recorded in a proper tabular format.
• In addition, a graphical presentation of stability
data versus time forthe test data can be used to
illustrate trends in data and may behelpful for data
evaluation