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, and light, and 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 which 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:.
This applies to situations where a drug product may be stored in a bulk container for a period of time prior to its placement into end-user packaging.
That being said, FDA understands that drug owners would face undue hardship if they were required to wait the full two years it would take to generate RT stability data before launching a new OTC drug product with a 2-year expiration date.
As a result, FDA allows for the extrapolation of accelerated stability data for determining expiry dating for initial launch, however FDA also requires that the same batch that was used for the accelerated study must also undergo concurrent RT stability testing.
Accelerated stability studies alone cannot be used to support the expiration dating of OTC drug products.
The results of accelerated studies must be confirmed through the conducting of RT stability studies. As stated in the previous section, the results of accelerated stability studies may be used to approximate the shelf life of a new OTC drug product for launch. Historically, FDA has permitted three 3 months of acceptable accelerated stability test results to support a 2-year expiration date for product launch.
Expiration dating and stability testing
However, in recent years, FDA has tightened up its stability requirements for prescription Rx drugs, now requiring six 6 months of accelerated stability and one 1 year of RT stability data at the time of submission, and for it, granting only an month sometimes less expiration date. Since OTC drug policy eventually tends to follow along the lines of Rx policy, it is prudent that for the launch of new OTC drug products, that six 6 months of accelerated stability testing now be conducted to support a 2-year expiry date for launch.
It should also be noted that anything less than three 3 months of acceptable accelerated stability data cannot be routinely used to support any expiry date.
Extending the accelerated storage time or storing under harsher conditions will not routinely support a 3-year expiration date. All Rights Reserved. Interested in participating in our trials?
§ Stability testing. (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be . May 13, Food Shelf Life Stability testing is a very important and very big part of today's food industry. Shelf life testing helps determine expiration dates and other product claims. Products having a shelf life of two years or more do not need to display a "best before" date. ITG SUBJECT: EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS. BACKGROUND. Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals.
Neumann October 26, What is a Stability Study and What is its Purpose? Examples of the most common stability conditions are as follows: Real Time or Room Temperature RT Stability Study A stability study conducted under controlled temperature and humidity approximating conditions of long-term storage. Accelerated Stability Study A stability study conducted under exaggerated conditions, in an attempt to accelerate the aging process, i.
Expiration Dating and Stability Testing for Human Drug Products: Drugs: 10/18/ Tin Whiskers - Problems, Causes, and Solutions: Medical Devices: 3/14/ Lyophilization of Parenterals. BACKGROUND: Revisions to 21 CFR Part , Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMP) introduced requirements concerning expiration dating (21 .
Intermediate Stability Study A stability study that is conducted under conditions that are intermediate between long-term and accelerated storage conditions. Photostability Study A study that is conducted to determine the effect that either whole or ultraviolet light has upon the stability of a product.
ICH Stability Testing and Method Development
Bulk Hold Stability Study A stability study that is conducted under long-term conditions to assess the stability of a product batch in its bulk container. Interpretation of Accelerated Stability Studies As stated in the previous section, the results of accelerated stability studies may be used to approximate the shelf life of a new OTC drug product for launch.
The first three 3 commercial batches of the drug product must be placed on RT Stability. Graphical Aid to Determine Gas Concentration.
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For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA. Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron Guidance for Industry June may meet stability and expiration dating requirements. All over-the-counter (OTC) and prescription (Rx) drug products distributed within the USA are required to display an expiration date that is supported by stability studies which have been conducted in accordance with current FDA and ICH Guidelines. Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing.
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