Review of stability of packaged material like containers and closures.
The whole ppt is regarding the test perform to know the stability of a container which is used for product storage.
It also contain the guidelines of ICH.
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Review of pharmaceutical product, packaging and ich
1. :Recreated and edited by Deepak Shukla
3rd B.Pharm, I.C.P.R
Review of Pharmaceutical product, packaging and ICH
guidelines
2. • Packaging is nothing but the proper storage of enclosing or protecting
products for distribution, sale, and use from the time of production.
Important factor
• Protects the product
• Safety
• Usability
• Displays and promotes the product
• Attracts buyers
• Sustainability
What is packaging?
3. The purpose is to provide proper evidence on how the quality of a package
varies with time under influence of variety of environmental conditions such
as:
• Temperature
• Humidity
• Light
• Shelf life
• Storage conditions
Purpose of stability testing
4. STABILITY TESTING
Stability testing of pharmaceutical products is a complex set of procedures
involving considerable cost, time consumption and scientific expertise in
order to build in quality, 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 those of the
formulated products.
5. STABILITY TESTING CONT.
Stability testing is termed as a complex process because of involvement of a
variety of factors influencing the stability of a pharmaceutical product.
These factors include:
Stability of the active ingredient(s);
interaction between active ingredients and excipients, manufacturing
process followed, type of dosage form, container/closure system used for
packaging.
Light, heat and moisture conditions encountered during shipment, storage
and handling.
6. STABILITY TESTING CONT.
Stability testing is a routine procedure performed on drug substances and
products and is employed at various stages of the product development.
In early stages, accelerated stability testing (at relatively high temperatures
and/or humidity) is used in order to determine the type of degradation
products which may be found after long-term storage.
Testing under less rigorous conditions i.e. those recommended for long-
term shelf storage, at slightly elevated temperatures is used to determine a
product's shelf life and expiration dates.
7. AIM
The major aim of pharmaceutical stability testing is:
To provide reasonable assurance that the products will remain at an
acceptable level of fitness/quality throughout the period during which they
are in market place available for supply to the patients.
And will be fit for their consumption until the patient uses the last unit of the
product.
8. PHARMACEUTICAL PACKAGE STABILITY TESTING
Compression Strength Testing: Provide a comprehensive report with
data on the strength of a package.
Distribution Simulation Testing: Packages experience many different
forces during the shipping an distribution process. It is the product
manufacturer's responsibility to evaluate and document the ability of the
package to withstand the distribution and storage environments.
Package Integrity Testing: It uses established tests to test the integrity of
a pharmaceutical package, Such tests include dye leak, visual inspection,
vacuum leak and bubble leak testing to inspect the package integrity
capabilities.
9. Package Strength Testing: Package strength testing is conducted to
measure and ensure that the components of the package will not separate
when specific forces are applied. The testing of flexible components such
as pouches, seal peel or burst testing are methods used to prove the
packages strength.
Vibration Testing: Packages and products experience a wide range of
dynamic forces and stresses during distribution that could harm a product.
It performs vibration tests on samples to simulate the stresses and forces a
package/product would experience during the distribution process.
Shock and Vibe Testing: Dropping, rotational edge dropping and rotational
flat drop tests to simulate real world exposure of the package to shock
forces by forklifts, package handling or other factors in the distribution
cycle.
10. 1) CLIMATIC ZONES FOR STABILITY TESTING
For the purpose of stability testing the whole world has been divided into
four zones (I- V) depending upon the environmental conditions the
pharmaceutical products are likely to be subjected during their storage.
These conditions have been turned on the basis of the mean annual
temperature and relative humidity data in these region
14. ORIENTATION OF STORAGE OF CONTAINER
Samples of the solutions, dispersed systems and semi solid drug products
for stability studies must be kept upright and positioned either inverted or on
the side to allow for full interaction of the product with the container-
closure.
This orientation helps to determine whether the contact between the drug
product or solvent and the closure results in the extraction of chemical
substances from the closure components or adsorption of product
components in to the container- closure.
15. TEST PARAMETERS
The stability test protocol should define the test parameters that would be
used for evaluation of the stability samples.
The tests that monitor the quality, purity, potency, and identity which could
be expected to change upon storage are chosen as stability tests.
Therefore appearance, assay, degradation products, dissolution,
microbiological testing, and moisture are standard tests performed on
stability test samples.
Microbiological tests include sterility, preservative efficacy and microbial
count as applicable e.g. for liquid injectable preparations.
The batches used for stability study must meet all the testing requirements
including heavy metals, residue on ignition, residual solvents.
16. PRESENTATION AND RECORDING OF STABILITY DATA
Stability data is recorded in an organized, comprehensive and cumulative
format.
The stability data table is the means for reporting the results of the stability
study in a concise format for ease of review and interpretation.
The data is recorded in a proper tabular format.
In addition, a graphical presentation of stability data versus time for the test
data can be used to illustrate trends in data and may be helpful for data
evaluation.
17. ICH
ICH stands for “International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use”.
ICH GUIDELINES
The guidelines of ICH are broadly categorized into four types.
1) Quality guidelines
2) Safety guidelines
3) Efficacy guidelines.
4) Multidisciplinary guidelines
18. OBJECTIVES OF ICH
Promote public health by early availability of drug in the market.
Maintaining safeguards on quality, safety and efficacy.
Improve efficiency of new drug development
Reduce registration cost.
Less expensive drugs for patients.
19. QUALITY GUIDELINES
Q1A - Q1F :Stability
Q2 : Analytical Validation
Q3A - Q3D : Impurities
Q4 - Q4B : Pharmacopoeias
Q5A - Q5E : Quality of Biotechnological Products
Q6A- Q6B : Specifications
Q7 : Good Manufacturing Practice
Q8 : Pharmaceutical Development
Q9 : Quality Risk Management
Q10 : Pharmaceutical Quality System
Q11 : Development and Manufacture of Drug Substances
Q12 : Lifecycle Management
Q13 : Continuous Manufacturing of Drug Substances and Drug Products
Q14 : Analytical Procedure Development
21. EFFICACY :
The work carried out by ICH under the Efficacy heading is concerned with the
design, conduct, safety and reporting of clinical trials. It also covers novel types of
medicines derived from biotechnological processes and the use of pharmacogenetics
/ genomics techniques to produce better targeted medicines.
It includes E1- E18 guidelines
MULTIDISCPLINARY :
These are the cross-cutting topics which do not fit uniquely into one of the Quality,
Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA),
the Common Technical Document (CTD) and the development of Electronic
Standards for the Transfer of Regulatory Information (ESTRI).
It includes M1- M10 guidelines.
