Stability Testing definition

Stability Testing means the formal shelf life testing of the Product in each packaging configuration according to current USP standards.
Sample 1Sample 2Sample 3
Stability Testing means the storage of the Product in defined packaging configurations, under controlled temperature and humidity conditions, for the purpose and execution of periodic testing of the Product according to any protocol approved by both Parties.
Sample 1Sample 2
Stability Testing shall have the meaning set forth in Section 10.3.6.
Sample 1

Examples of Stability Testing in a sentence

  • Stability Testing Under 21 CFR 312.23(a)(7)(ii), you must conduct stability testing in all phases of the IND, to demonstrate that the product is within acceptable chemical and physical limits for the planned duration of the proposed clinical investigation.

  • For further information, refer to ICH Q5C: “Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products,” (Ref.

  • Optimization Techniques & Pilot Plant Scale Up Techniques Stability Testing, sterilization process & packaging of dosage forms.

  • It should be read with other documents and guidelines, including but not limited to, WHO Guidelines on Stability Testing, Good Storage and Distribution Practices, Donations, Model Quality Assurance System for Procurement Agencies (MQAS), Pharmacopoeia, ICH guidelines, and other related guides and recommendations.

  • All of Mikart’s costs incurred in connection with the Validation, the Stability Testing and the storage of data related thereto shall be periodically billed to and paid by Vertical.

  • Mikart shall maintain Stability Testing and Validation data at its Atlanta, Georgia facilities or at such other location as agreed to by Vertical and Mikart in accordance with FDA regulations.

  • FRESENIUS shall start a Stability Testing Program using three suitable batches to assess the long-term stability of the Products, as described in the Project Plan of Exhibit A.

  • Results of these studies may reveal product differences that warrant additional evaluations and also identify conditions under which additional controls should be employed in manufacturing and storage (see ICH guidances for industry Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products and Q1A(R2) Stability Testing of New Drug Substances and Products).

  • The Contractor shall perform Thermal Vacuum Stability Testing of materials to determine the characteristics of materials when exposed to vacuum conditions, as defined by the Johnson Space Center (JSC) document SP-R-0022/ASTM-E-595, and any variations thereof.

  • Oct, ICH, Q1A, Stability Testing of New Drug Substances and Products.


More Definitions of Stability Testing

Stability Testing shall have the meaning set forth in Section 4.2 of this Agreement. * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
Sample 1
Stability Testing shall have the meaning set forth in Section 4.2 of this Agreement.
Sample 1

Related to Stability Testing

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • Penetration Testing means security testing in which assessors mimic real-world attacks to identify methods for circumventing the security features of an application, system, or network. (NIST SP 800-115)

  • Test means such test as is prescribed by the particulars or considered necessary by the Inspecting Officer whether performed or made by the Inspecting Officer or any agency acting under the direction of the Inspecting Officer;

  • Screening Test means a drug or alcohol test which uses a method of analysis allowed by the Minnesota Drug and Alcohol Testing in the Workplace Act to be used for such purposes.

  • Maintenance Test means the maintenance test set out in Clause 12.1 (Maintenance Test).

  • Genetic testing means an analysis of genetic markers to exclude or identify a man as the father or a woman as the mother of a child. The term includes an analysis of one or a combination of the following:

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Collateral Quality Tests means the Collateral Quality Tests set out in the Investment Management Agreement being each of the following:

  • Collateral Quality Test means a test that is satisfied if, as of any date of determination, in the aggregate, the Collateral Loans owned (or in relation to a proposed acquisition of a Collateral Loan, both owned and proposed to be owned) by the Borrower satisfy each of the tests set forth below, calculated in each case in accordance with Section 1.3:

  • S&P CDO Monitor Test A test that will be satisfied on any date of determination (following receipt, at any time on or after the S&P CDO Monitor Election Date, by the Issuer and the Collateral Administrator of the Class Break-even Default Rates for each S&P CDO Monitor input file (in accordance with the definition of “Class Break-even Default Rate”)) if, after giving effect to a proposed sale or purchase of an additional Collateral Obligation, the Class Default Differential of the Highest Ranking Class of the Proposed Portfolio is positive. The S&P CDO Monitor Test will be considered to be improved if the Class Default Differential of the Proposed Portfolio that is not positive is greater than the corresponding Class Default Differential of the Current Portfolio.

  • Start-Up Testing means the completion of applicable required factory and start-up tests as set forth in Exhibit C.

  • Coverage Tests The Overcollateralization Ratio Test and the Interest Coverage Test, each as applied to each specified Class or Classes of Secured Debt.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • RDDS test Means one query sent to a particular “IP address” of one of the servers of one of the RDDS services. Queries shall be about existing objects in the Registry System and the responses must contain the corresponding information otherwise the query will be considered unanswered. Queries with an RTT 5 times higher than the corresponding SLR will be considered as unanswered. The possible results to an RDDS test are: a number in milliseconds corresponding to the RTT or undefined/unanswered.

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • Performance Test means all operational checks and tests required to determine the performance parameters including inter-alia capacity, efficiency and operating characteristics of the Stores as specified in the Contract.

  • Coverage Test means each of the Class A/B Par Value Test, the Class A/B Interest Coverage Test, the Class C Par Value Test, the Class C Interest Coverage Test, the Class D Par Value Test, the Class D Interest Coverage Test, the Class E Par Value Test and the Class E Interest Coverage Test.

  • DNS test Means one non-­‐recursive DNS query sent to a particular “IP address” (via UDP or TCP). If DNSSEC is offered in the queried DNS zone, for a query to be considered answered, the signatures must be positively verified against a corresponding DS record published in the parent zone or, if the parent is not signed, against a statically configured Trust Anchor. The answer to the query must contain the corresponding information from the Registry System, otherwise the query will be considered unanswered. A query with a “DNS resolution RTT” 5 times higher than the corresponding SLR, will be considered unanswered. The possible results to a DNS test are: a number in milliseconds corresponding to the “DNS resolution RTT” or, undefined/unanswered.

  • Performance Tests means the tests to be conducted on the equipment at site for checking the performance parameters of the equipment as defined in Technical Specification.

  • Security Tests means conduct tests of the processes and countermeasures contained in the Security Plan.

  • Genetic test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detect genotypes, mutations, or chromosomal changes. The term “genetic test” does not mean an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.

  • EPP test Means one EPP command sent to a particular “IP address” for one of the EPP servers. Query and transform commands, with the exception of “create”, shall be about existing objects in the Registry System. The response shall include appropriate data from the Registry System. The possible results to an EPP test are: a number in milliseconds corresponding to the “EPP command RTT” or undefined/unanswered.

  • Cannabis testing facility means an entity registered by

  • Fit test means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

  • Commissioning test means tests applied to a distributed generation facility by the applicant after construction is completed to verify that the facility does not create adverse system impacts and performs to the submitted specifications. At a minimum, the scope of the commissioning tests performed shall include the commissioning test specified in Institute of Electrical and Electronics Engineers, Inc. (IEEE) Standard 1547 Section 5.4 "Commissioning tests".

  • Percolation test means a subsurface soil test at the depth of a proposed absorption system or similar component of an OWTS to determine the water absorption capability of the soil, the results of which are normally expressed as the rate at which one inch of water is absorbed. The rate is expressed in minutes per inch.