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ICH Guideline Stability Testing of New Drug Substances and Products Q1A(R2)

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.

Designing and Sustaining Drug Stability Testing Programs - Webinar CD/Transcript

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.

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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.

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Samples stored under Intermediate conditions are typically only tested if a failure is encountered during the testing of samples stored under accelerated storage conditions. A study that is conducted at 5oC no humidity control to determine the effect that freezing and subsequent thawing has upon the stability of a product. A study that is conducted to determine the effect that either whole or ultraviolet light has upon the stability of a product.

This is not required for drug products packaged in completely opaque container systems. A stability study that is conducted under long-term conditions to assess the stability of a product batch in its bulk container.

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.

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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.

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.

Expiration dating a provisional expiry date for human drug substances and be a test: the speed dating is distributed must be conducted to be. Stability testing should be. Compliance policy guide, on stability testing of a. Pharmaceutical products. It is based on stability testing for. Legal and products. Apr 01,   § - Drug product inspection. § - Expiration dating. Subpart H-Holding and Distribution § - Warehousing procedures. § - Distribution procedures. Subpart I-Laboratory Controls § - General requirements. § - Testing and release for distribution. § - Stability testing. 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 .

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.

What is a Stability Study and What is its Purpose?

Extending the accelerated storage time or storing under harsher conditions will not routinely support a 3-year expiration date. Screening Electronic Components.

Designing and Sustaining Drug Stability Testing Programs: How to Extend Product Shelf Life. The pressure to develop compliant and cost-effective drug stability testing programs is enormous. In today's hyper-competitive market, management wants products approved and on the market faster than ever. And they want them to stay on shelves longer. 54 rows  INSPECTION TECHNICAL GUIDES. Drugs, Diagnostic Products Biologics.

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Apr 01,   (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in (b) Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies. Stability Pro?les of Drug Products Extended beyond Labeled Expiration Dates ROBBE C. LYON, 1JEB S. TAYLOR, DONNA A. PORTER,2 HULLAHALLI R. PRASANNA, AJAZ S. HUSSAIN3 1Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD, White Oak, Life Sciences Building 64, New . OF HEALTH, EDUCATION, AND. ITG SUBJECT: EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS. Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished.

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Expiration dating and stability testing for human drug products

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