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Topic: Stability testing

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	Software testing - Wikipedia, the free encyclopedia
		Unit tests are maintained along with the rest of the software source code and generally integrated into the build process (with inherently interactive tests being relegated to a partially manual build acceptance process).
		Testing during the beta phase, informally called 'beta testing, is generally constrained to fl box techniques although a core of test engineers are likely to continue with white box testing in parallel to the beta tests.
		Test Reporting: Once testing is completed, testers generate metrics and make final reports on their test effort and whether or not the software tested is ready for release.
	en.wikipedia.org /wiki/Software_testing (4043 words)

	Stability Testing of Existing Drug Substances and Products
		Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy.
		The purpose of the stability study is to establish, based on testing a minimum of batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a retest period applicable to all future batches of the drug substance manufactured under similar circumstances.
		Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labelling on the preparation, storage condition, and in-use period of the constituted or diluted product.
	www.hc-sc.gc.ca /dhp-mps/prodpharma/applic-demande/guide-ld/chem/stabt_stabe_e.html (9200 words)

	(Regulatory Focus) Stability Testing for New Drugs (PMPN archive, Jan 02)
		Nonetheless, the guidance states stability studies on a drug substance should be conducted while it is packaged in a container-closure system that is the same as or simulates the packaging proposed for storage and distribution.
		For drug products, data from stability studies should be provided on at least three primary batches, and the studies should be performed on each individual strength and container size of the drug product, unless bracketing or matrixing (techniques in which the testing frequency is reduced or certain factor combinations are not tested) is being employed.
		Testing on a single batch at an elevated temperature for an appropriate time period should be conducted to address the effect of short-term excursions outside the proposed storage condition listed on the label.
	www.devicelink.com /pmpn/archive/02/01/016.html (731 words)

	Q1A Stability Testing of New Drug Substances and Products
		The stability protocol used for long-term studies for the stability commitment should be the same as that for the primary batches, unless otherwise scientifically justified.
		The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a retest period applicable to all future batches of the drug substance manufactured under similar circumstances.
		The stability protocol used for studies on commitment batches should be the same as that for the primary batches, unless otherwise scientifically justified.
	www.fda.gov /cder/guidance/4282fnl.htm (6962 words)

	Stability+Lab Information Management System
		Stability testing is a routine procedure performed on drug products, active ingredients and excipients in order to understand the long-term effects of the environment on the drugs.
		In the early stages, accelerated stability testing (high temperatures and relative humidity) is used to evaluate the stability of the drug and to determine what types of degradation products may be found after long-term storage.
		Testing under normal conditions (those recommended for long-term shelf storage) can be used to determine a product’s shelf life and expiration dates.
	www.thermolabindia.com /Scheduler.htm (1100 words)

	Chilworth Technology - THERMAL STABILITY TESTING
		The powder layer test is used to evaluate the thermal stability of powders and dusts in dryers where heated air is circulated over a powder layer.
		The Bulk Solid Test is used to evaluate the thermal stability of bulk solids, powders, and dusts during drying and related operations.
		The Aerated Powder Test is used to evaluate the thermal stability of powders and dusts during drying operations in which a heated air stream passes through the material, such as in circulating band and fluidized bed dryers.
	www.chilworth.com /lab_thermo.cfm (259 words)

	Structural Stability Testing (Site not responding. Last check: 2007-11-02)
		Tests for the structural stability of the parameters and the overidentifying restrictions can be performed by selecting the Stability entry, under the Testing field.
		Unknown breakpoint: sup-, Av-, and Exp- functional of the sequence of the Wald, LM, D, and O tests.
		The first P rows on each column are the estimates before the break, whereas the last P are the estimates after the break.
	www4.ncsu.edu /~kkyriak/help/strstab.htm (464 words)

	The klaxon latex stability rubber testing apparatus test machine
		The latex rubber stability test machine / apparatus tests the mechanical stability of concentrated natural and synthetic latex rubber when subjected to high speed mechanical stirring or mechanical shear.
		The mechanical stability value for a latex is expressed as the number of seconds elapsed from the start of the test to the end point.
		The Latex Rubber Test Machine has a highly reliable series wound motor which is electronically controlled and incorporates a feedback system to accurately maintain the selected speed.
	www.secomak.com /latex_testing.asp (377 words)

	Fuel Stability Testing (Site not responding. Last check: 2007-11-02)
		Test results are reported in accordance with your deadlines.
		The P-Value or Petpization Value test allows buyers and sellers of residual fuel oil to determine the stability reserve of a finished fuel product as well as help traders determine whether their product is straight-run residue' or derived from cracked fuel oil.
		Stability, and stability reserve required for refinery process (thermal cracking) control purposes.
	www.itscb.com /newsitetest/services/nl/fuelstabilitytesting.shtml (463 words)

	Pharmaceutical Technology: Toward a generic approach for stress testing of drug substances and drug products (Site not responding. Last check: 2007-11-02)
		Stress testing is defined as the stability testing of drug substances and drug products under conditions exceeding those used for accelerated testing.
		This article discusses stress testing according to the regulatory guidance documents, with emphasis on what should be considered for late-clinical phases and for registration application dossiers (e.g., marketing authorization applications or new drug applications).
		The experimental conditions to conduct stress tests are described in a general way and the exact stress conditions to be applied are not described.
	www.findarticles.com /p/articles/mi_m0EEH/is_2_29/ai_n11836426 (1334 words)

	Stability Studies
		Matrix Stability Express TK was designed in conjunction with several major Pharmaceutical companies to manage and report on protocol driven studies associated with pharmaceutical stability or shelf-life testing.
		As stability samples are taken from a stability storage room, information is automatically registered onto the results system and the appropriate tests and limits allocated according to the protocol requirements.
		Often, stability systems are provided as "add-on" modules to commercial LIMS, providing little more than simple sample and test scheduling with very limited functions for the stability worker in areas such as planning, storage and inventory control.
	www.autoscribe.co.uk /stabilitymanager.shtml (603 words)

	Overclockers Forums - Guidelines for Thorough Stability Testing
		An hour of such testing with a periodic check for any artifacting is usually sufficient, although it's a very good idea to do a few runs of all the game tests afterwards as well.
		Other tests in newer versions of 3DMark can also be very effectively used to detect artifacting and video card instabilty, although the 3DMark 2001 SE Nature test is still the best at getting your video card's core and RAM temperatures to a peak.
		However, 24 hours of all the tests on loop is your end-all solution to memory stability testing.
	www.ocforums.com /showthread.php?t=335813 (5063 words)

	Pharmaceutical Stability Studies (Site not responding. Last check: 2007-11-02)
		In early stages, accelerated stability testing (at relatively high temperatures and/or humidities) can be used as a “worst case” evaluation to determine what types of degradation products may be found after long-term storage.
		Testing under more gentle conditions (those recommended for long-term shelf storage), and slightly elevated temperatures, can be used to determine a product’s shelf life and expiration dates.
		Retained samples can be tested alongside returned samples to ascertain if the problem was manufacturing or storage related.
	www.wcaslab.com /TECH/STABLE.HTM (193 words)

	PassMark BurnInTest software - PC Reliability and Load Testing
		Test the stability of a system after configuration changes or hardware upgrades (critical for overclocking).
		What BurnIn Test does is thoroughly exercise the hardware in a PC in a short period of time, in the same way as normal applications use a PC over a long period of time.
		Testing can be performed on up to 64 serial ports at the same time.
	www.passmark.com /products/bit.htm (863 words)

	Pharmaceutical Stability Studies and Stability Testing Services at Boston Analytical
		Boston Analytical offers a wide range of stability testing services in compliance with FDA and ICH guidelines.
		Stability samples are tracked and scheduled for testing by our computerized stability database.
		This system tracks the status of your sample from receipt through storage, testing and generation of reports.
	www.bostonanalytical.com /stability.htm (126 words)

	Stability Programs from Development to Approval - An Overview
		Practical techniques are reviewed to improve the integrity of the stability data and ensure that test results comply with FDA and ICH requirements.
		By the end of the two-day retreat, attendees will gain the skill set to interpret regulatory guidelines, design compliant stability program, and effectively prepare for an FDA inspection in their stability testing laboratory and sample storage facility.
		Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program.
	www.cfpie.com /showitem.aspx?productid=072 (807 words)

	Software Load/Stress/Stability Testing - NTS QA Software Testing Labs - NTS - National Technical Systems, Inc. (Site not responding. Last check: 2007-11-02)
		Load and stress testing allows you to discover the maximum performance for your software product or to uncover anomalies or instabilities that may only become apparent over an extended period of time or under high usage.
		Testing can be performed on software products like database software, web server software, etc. Even applications like word processors and spreadsheets can be load/stress tested to uncover memory leaks, etc. that may only appear over time.
		Term licensing allows smaller companies the opportunity to test on a one-off basis using highly respected (and very expensive) test tools and affords larger companies an opportunity to evaluate whether or not the tool meets their needs before purchase.
	www.ntscorp.com /services/service_detail.php?id=132?tstcat=16 (641 words)

	Speedy 3D
		Stability Testing Your PC There are easy ways to identify a potential stability problem.
		Stability plays an essential part of overclocking, and your systems health as a whole.
		Because the processor is the popular element to overclock, there are many programs and methods to test how stable your CPU really is. Once you have eliminated the processor as the source of instability you can move onto the next factor.
	www.speedy3d.com /articles/stability_testing (435 words)

	Successful Stability Testing Strategies
		Properly planned, executed and managed stability studies are critical for understanding data generated during clinical trials.
		As with clinical trials, it is imperative to properly plan, document and manage stability study cycles or programs.
		There are several items to be considered and planned for which, if addressed, can result in reliable information-rich data or, if overlooked, may result in investigations or jeopardize approval of the drug.
	www.bioresearchonline.com /content/news/article.asp?docid=8d5b7f4b-9843-41f3-ad8b-68839067e4f6 (126 words)

	Stability Testing (Site not responding. Last check: 2007-11-02)
		The Quality Working Group (QWG) was mandated with evaluating the relevance/applicability of ICH stability guidance documents and development of corresponding VICH stability guidance documents.
		The GL8 guidance document "Stability Testing for Medicated Premixes" has no corresponding ICH document and was developed independently through the VICH process.
		The VICH documents provide guidance on stability testing of new veterinary drug substances and medicinal products as part of Registration Applications submitted to the European Union, Japan, and the United States.
	vich.eudra.org /documents/abstracts/ABMarnane.html (77 words)

	Microbac - Pharmaceuticals - Stability Testing
		Whether your drug substance is investigational, your key product is already on the market, or your article is still in the approval process, Microbac offers a variety of stability storage and testing services.
		Microbac can assist with protocol design, on-going sample testing, and trends analysis during, and at the conclusion, of testing.
		Submit details of your testing needs for a prompt response.
	www.microbac.com /services/stability_testing.php (140 words)

	ICH
		It extends the main stability guideline for new formulations of already approved medicines and defines the circumstances under which reduced stability data can be accepted.
		The purpose is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies.
		This document augments the stability guideline (Q1A above) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.
	www.ich.org /UrlGrpServer.jser?@_ID=363&@_TEMPLATE=272 (3017 words)

	BurnInTest : PC reliability and stability testing
		BurnInTest is a software tool that simultaneously exercises all of the major components of a computer, to test for endurance and reliability.
		The user can select the hardware components to test and individually adjust the load placed on each one via slide bars.
		Each test reports results to its own window and results are summarised along with any errors detected in the main program window.
	fileprofile.com /Utilities/benchmarking/burnintest (346 words)

	Complying with FDA/ICH Requirements for Stability Testing - Training Overview
		Establish a standard stability protocol and develop appropriate strategies for each phase of pharmaceutical development in order to streamline processes
		Validate and design stability test methods, including evaluation of forced degradation studies, to generate meaningful data
		PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education.
	www.pti-international.com /stabilitytesting (299 words)

	Pharmaceutical Stability Programs - Event Overview
		The mission of this program is to present specific information on how to achieve maximum efficiencies in analytical stability testing and related new regulatory processes for both small and large molecules, ultimately to drive down the risk of unexpected costs and non-informative analysis.
		The first focuses on Stability Program Management, looking at the big picture, so that you are able to run your stability program more efficiently and enhance testing effectiveness.
		We are proud to bring you stability experts who are working to improve large and small molecule stability programs.
	www.iirusa.com /stability (717 words)

	Stability testing (Site not responding. Last check: 2007-11-02)
		A Pharmacy Department Stability Study Sheet (Records and Reports, P 10.215 must be completed by the QA officer before a drug will be considered for study.
		The dates for testing are predetermined at the study design, placed on queue in a log book and it is the responsibility of the QA officer to see that these sheets are up to date and filed properly.
		The actual testing is coordinated by the manufacturing area.
	www.mgh.harvard.edu /pharmacy/POM/p10-150.htm (269 words)

	Management Forum STABILITY TESTING - To be held in Barcelona
		Management Forum STABILITY TESTING - To be held in Barcelona
		STABILITY TESTING - To be held in Barcelona
		The relevance of ICH and other guidelines will be demonstrated and delegates will learn how to generate re-test dates for drug substances and shelf lives for drug products.
	www.management-forum.co.uk /html/con_semin_section/con_display_event.asp?id=175 (70 words)

	Cirrus Laboratories - Stability testing. Batch release testing. Raw material testing. (Site not responding. Last check: 2007-11-02)
		Cirrus Laboratories are pleased to announce a new initiative to provide services to the global pharmaceutical and biotechnology industries.
		Whether you are thinking about outsourcing all your stability testing and storage or simply trying to cope with capacity overloads, Cirrus Laboratories can provide the solution.
		Testing laboratory focused courses aimed at the pharmaceutical and related industries.
	www.cirruslabs.co.uk (222 words)

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