This instalment is the first in a series of three white papers on stability studies and testing of pharmaceuticals, as well as the development and validation of stability-indicating high performance liquid chromatography HPLC methods. This first instalment provides a comprehensive and updated overview of stability studies and testing of small molecule drugs, current regulatory requirements, and industry practices for forced degradation, as well as possible approaches for reduced testing and data evaluation to expedite stability study timelines. Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products. The shelf life of medicines is set following stringent regulations; therefore, efficient application of stability science is critical. The shelf life expiration dating or expiry is displayed on labels of pharmaceutical products to ensure the integrity, quality, and potency of the product when used within that time period. Shelf life is established using data that are generated to verify the label claim, and approved by the regulatory agencies. An expiration date is required by regional laws to ensure the safety, efficacy, and quality of the drug products, and that these criteria are maintained throughout the labelled shelf life of the pharmaceutical product. Most companies have established standard operating procedures SOPs to supplement regulatory guidelines to provide more specific details, and ensure that stability studies are appropriate for their specific product types.
Regulatory Guidelines on Stability Testing and Trending of Requirements
Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity. After the established re-test period has elapsed, a drug substance can only be used if additional specification testing is performed, the material passes inspection, and the substance is distributed soon after meeting acceptance criteria. For a drug product, stability testing determines the shelf-life of the product by establishing the duration for which the product is safe to use and retains therapeutic value according to the level of the active ingredient s.
Acceptance criteria are stipulated before initialization of the study, and if a product fails to meet specifications at any time point, the stability study may be halted and restarted after reformulation or other modifications have occurred. For a drug substance stability study, the ICH guidance recommends utilizing a minimum of three batches of product. The batches should be manufactured to a minimum of pilot scale.
Cannabis products with accurate expiration dates are essential for A stability study is an examination of a substance or product over a specified period of Using ICH guidelines we recommend the following conditions, time.
Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale. It applies to cosmetics , foods and beverages , medical devices , medicines , explosives , pharmaceutical drugs , chemicals , tyres , batteries , and many other perishable items. In some regions, an advisory best before , mandatory use by or freshness date is required on packaged perishable foods.
The concept of expiration date is related but legally distinct in some jurisdictions. Shelf life is the recommended maximum time for which products or fresh harvested produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected or specified conditions of distribution, storage and display. If the cans look okay, they are safe to use.
Discard cans that are dented, rusted, or swollen.
Holistic Primary Care
A total of fifty-five participants that included experienced pharmaceutical scientists, both from small and large pharmaceutical companies and service providers, benefited from the opportunity to interact face-to-face with industry partners and regulatory agency SMEs. The two-day meeting was divided into five major sections to ensure face-to-face interactions and round-table discussions between participants and SMEs: 1 statistical approaches to stability, dissolution, and shelf life testing, 2 microbiological quality of drug products, 3 strategies to support distribution, unplanned excursions, and transportation of drug products, 4 regulatory considerations on stability testing of biologics, and 5 in-use stability during clinical and commercial phases.
The interactive meeting provided a unique opportunity to industrial scientists and regulatory agency liaisons to facilitate the discourse on how to address stability challenges that are not addressed in harmonized guidelines: this paper summarizes those discussions. The meeting was organized by the members of the Stability Focus Group steering committee to facilitate face-to-face discussion with members of regulatory agencies to address stability concerns through science and risk-based approaches.
During drug development and commercial distribution of drug products, there are a number of regulatory expectations on their stability for which there is limited guidance from the International Conference on Harmonization ICH.
The phrase “shelf life” and “expiry date” is often interchangeably used in Common Stability Chamber Storage Conditions Used For Product.
Each of these guidelines and cosmetic requirements read more about the full list of requirements here , labeling included, must be strictly adhered to by manufacturers for any cosmetic product seeking to enter the European Market. Two important inclusions under the regulation that some manufacturers and consumers alike often find confusing are the Expiration Date and the Period After Opening PAO.
Both factors are evaluated during this process in an effort to ensure maximum safety for the consumer. Essentially, the period of time it is safe to use and will perform its function within. Depending on the type and nature of the product, an expiration date can very. This can be relative to a number of factors:. In cases where the shelf life exceeds 30 months an expiration date is not required to be placed on the packing, however a period after opening PAO is.
Period after opening PAO refers to the amount of time a product will remain stable and safe for human use after it has first been opened. As such, it is very much involved with the scale of degradation a product faces in the same way as the shelf life is, however in this instance it is far more directly influenced by its first use or first interaction with the consumer and the inevitable risk of microbial contamination therein.
Determination of PAO takes a number of factors into account, including product type and its claimed effects. It is important to note that in many cases these symbols can be misused.
Stability profiles of drug products extended beyond labeled expiration dates.
To help nutritional supplement companies make sure they have the necessary data to support expiration dating on product labels NSF International, developer of the U. NSF-DBA, an NSF International Company that provides dietary supplement training, consulting and testing services, worked in conjunction with regulators and industry trade groups to coordinate the development of the new guideline. The guideline outlines the science-based criteria necessary to support expiration dating in order to comply with the current Good Manufacturing Practices GMP for dietary supplements.
Designing and Sustaining New and Existing Product Stability Testing Program (COM) Storage Conditions Shelf Life Duration of Studies and Expiration Dates.
Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing. If you are contracting this work to a third party laboratory be sure that they can provide guidance to help navigate the regulatory and compendial guidelines, and you perform a quality system audit of their facility. A stability study is a program of testing that is designed to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity light, which enables recommended storage conditions, retest periods and shelf lives to be established.
Stability testing is required to be conducted for OTC drug products under the recommended conditions of storage appearing on the label, and at any other condition, the drug product might be exposed to during manufacturing, storage and shipping activities. As a result, there are a number of stability conditions that are commonly utilized in determining the stability of a drug product in its marketed package s.
Examples of the most common stability conditions are as follows:. A stability study conducted under controlled temperature and humidity approximating conditions of long-term storage. A stability study conducted under exaggerated conditions, in an attempt to accelerate the aging process, i. A stability study that is conducted under conditions that are intermediate between long-term and accelerated storage conditions. Samples stored under Intermediate conditions are typically only tested if a failure is encountered during the testing of samples stored under accelerated storage conditions.
U.S. Food and Drug Administration
Related Content. The FDA announced revised draft guidance on assigning expiration dates to unit-dose repackaged solid oral dosage form drug products. The guidance discusses the repackaging of solid oral dosage form drugs into unit-dose containers by repackaging firms that are required to:.
An expiration date is required by regional laws to ensure the safety, efficacy, and quality of the drug products, and that these criteria are.
Posted by Michelle Puglielli. Shelf life is the period of time, from the date of manufacture, that a drug product is expected to remain within its approved product specification while stored under defined conditions. Shelf life is typically expressed in units of months, i. The amount of time a product can stay stable under certain environmental conditions, equates to its shelf life. Usual time points for testing are at 0, 3, 6, 9, 12, 18, 24, 36 months, etc.
New products must also be placed on long-term stability to collect pertinent data that will help advise an expiry date. Typical time points for testing under this condition are 0, 3, and 6 month milestones. Accelerated conditions are important to determine the stability of a drug product prior to marketing , and prior to adoption of significant changes in formulation, manufacturing, procedures, or packaging materials that may affect the shelf life of the product. There should be an intermediate study time point coinciding with each accelerated time point up to 6 months.
Some intermediate studies allow for product to remain in storage up to 12 months. Your stability product specifications will vary depending on the nature of the product, i. Challenging potency means assaying for all active ingredients and related substances, in addition to preservatives and antioxidants, if applicable.
Shelf life testing helps determine expiration dates and other product claims. All products with a shelf life of less than two years must display this date. These help estimate physical, chemical, and microbiological stability of the food. Additionally, some foods require more study and testing to determine microbial growth or other studies. Stability Studies use stability chambers to test products by keeping them at specific temperatures and humidity levels throughout the study.
the proposed shelf-life, expiry date and storage conditions should be determined on the basis of the results of real time stability studies. Stability studies should.
While it is generally good manufacturing practice, neither the U. Food and Drug Administration FDA nor the European Commission require cosmetic manufacturers to conduct stability testing on products before commercially marketing them. Such information can prove useful to companies both externally and internally; externally in terms of creating successful products, and internally in terms of product development, material procurement and management, and lifecycle management.
This paper provides an overview of the basics manufacturers should consider when developing a stability testing protocol for cosmetic products. As is well-known, stability testing essentially is an experiment in which a batch of formula is created and placed into different environmental conditions for a set period of time. These conditions vary in temperature and humidity, and are meant to simulate what happens to the product during its life cycle.
In the pharmaceuticals field, both the FDA and the European Medicines Agency require the stability testing of products before they can be sold to consumers. The main purpose is to measure and document the potency of medications up until a predicted expiration date.