Stability Studies definition

Stability Studies. Stability Studies means, with respect to the Product, the performance of stability testing at one-tenth commercial scale in accordance with the stability protocol set forth in the ANDA for the Product.
View Source
Stability Studies is defined in the Quality Agreement.
View Source
Stability Studies. Stability Studies means, with respect to the Product, the performance of stability testing at one-tenth commercial scale in accordance with the stability protocol set forth in the ANDA for the Product. 1. 95. “Supply Chain”. Supply Chain, with respect to Product, means stable, reliable, and commercially practical sources to obtain all starting materials, biological products, biological molecules, chemicals, precursors, intermediates, and reagents of sufficient quantity, quality, and purity necessary to manufacture the required commercial quantities of the Product according to the Locked Manufacturing Process. “Supply Chain” includes commercial sources of all packaging components and packaging materials, including primary and printed packaging materials according to the standards set forth in the ANDA for the Product.
View Source

Examples of Stability Studies in a sentence

  • Exhibits 1.3, 1.25, 2.1, 3.2 and 7.1 to this Agreement are subject to further revision and updating to reflect final, mutually agreed upon details concerning, among other things, Active Pharmaceutical Ingredient and Excipient Specifications, Product Specifications, Technology Transfer Activities, Stability Studies and Product Test Methods.

  • This includes, but is not limited to PoA, CPPs, GMPs, CTD, Batch Master Records (BMRs), Stability Studies including forced degradation data for Zone: IVA and IVB as promptly as practicable, signed original documentation, explanation letters following the Effective Date and post-marketing safety documents.

  • Stability Studies: Fifty percent (50%) of the stability chamber and protocol pricing is invoiced upon acceptance of Proposal or issuance of purchase order and due within 10 days; the remaining Fifty percent (50%) of the stability chamber and protocol price is invoiced upon delivery of the protocol and due within 10 days; all testing and related documentation will be invoiced after testing is performed and due within 10 days.

  • EXHIBIT 2.3 Payment of the Development Fee shall be in accordance with the following schedule: [***] Payment of the Development Stability Studies will be paid in accordance with the following schedule: [***] [ ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

  • Stability Studies will be conducted in accordance with the MSA or the Technology Transfer Agreement, as applicable.

  • With respect to the Transferring Stability Studies (as defined on Annex No. 2), until such transfer to Akebia is effectuated, BioVectra will maintain the ICH compliant stability programs, including [**].

  • X List of batch related Laboratory Investigations (LI) and records) X Copies of executed Master Batch Records (MBRs) X Copies of executed Test Records (TRs) X Certificate of Compliance((CoC) X Certificate of Analysis (CoA) X Lot genealogy report X GMP batch disposition Package X Stability Studies Activities: Protocol Specific Agree upon batches/lots to be placed on stability including testing time points and methods X X GeneFab Senti Bio Segregation and storage of stability materials per protocol.

  • Long-term Stability Studies ..............................................

  • This Validation process may include Stability Studies to current ICH standards.

  • Each of the Sub-Projects that attract and satisfy a milestone payment, other than Sub-Projects 5(d) and 7(d) Stability Studies, shall be invoiced on completion of the Sub-Project.