Reference Standard. Centaur shall provide Lundbeck from time to time ------------------ with reasonable quantities of Bulk Product of reference standard quality for analytical purposes free of charge.
Reference Standard. CENTAUR shall provide ASTRA from time to time with reasonable quantities of Substance of reference standard quality for analytical purposes.
Reference Standard. Two types of reference standard were used in this study: a segmentation reference standard, which was used in experi- ment 1, and a classification reference standard, used in experiment 2. The images of each patient were assessed by two expert readers in consensus: an MD researcher (reader 1) and an experienced radiologist (reader 2). As a common first step, all lymph nodes visible in the pelvic area were identified and numbered by reader 1.
Reference Standard. Specifications Where standard specifications or testing methods have been referred to, such as ASTM or AASHTO, the intent is to refer to the latest applicable issue or revision of such specifications or testing methods. The following abbreviations are used in these specifications. AWWA American Waterworks Association AASHTO American Association of State Highway and Transportation Officials ACI American Concrete Institute AI Asphalt Institute AISI American Iron and Steel Institute ANSI American National Standards Institute (formerly the USA Standards Institute) ASTM American Society for Testing and Materials NSF National Sanitation Foundation SPWC. Standard Specifications for Public Works Construction. (Wherever written herein shall mean "Maricopa Association of Governments, Arizona Specification for Public Works Construction".) APWA American Public Works Association The governing specifications for this project shall be the Maricopa Association of Governments (MAG) UNIFORM STANDARD SPECIFICATIONS for PUBLIC WORKS CONSTRUCTION, 1998 Arizona including revisions through 2007, MAG UNIFORM STANDARD DETAILS for PUBLIC WORKS CONSTRUCTION, 1998 Arizona including revisions through 2008, the Manual of Uniform Traffic Control Devices (MUTCD) 2003, ADOT Traffic Control Manual for Hwy Construction (Supplement) 1996, UNLESS OTHERWISE NOTED HEREIN. Reference: ARIZONA DEPARTMENT OF TRANSPORTATION, STANDARD SPECIFICATIONS for ROAD AND BRIDGE CONSTRUCTION 2008.
Reference Standard. 1 Government of Newfoundland and Labrador Department of Transportation and works, Highway Design Division.
Reference Standard. A. The Secretary of the Interiors “Standards for Rehabilitation” will be used as a reference standard.
Reference Standard. Providing high-quality, documented and qualified Reference Standards is critical to every batch released, and characterization can be an arduous process. In accordance with our QS, Reference Standards are produced and qualified prior to use in lot release, characterization or stability testing. The objective of this program is to provide complete documentation of the establishment and trending of product Reference Standards. Another goal of the program is to assess the suitability and availability of Reference Standards and critical reagents to meet ICH and FDA guidelines appropriate for the product lifecycle stage for which the materials will be used. This program results in complete documentation of these Reference Standards by providing: ■ Manufacture according to approved batch record or protocol ■ Qualification according to approved qualification protocol ■ Lot release testing according to approved technical specification ■ Generation of a COA detailing the lot release testing results ■ Controlled storage conditions and inventory ■ Stability testing ■ Continual data trending and evaluation of suitability in new/revised analytical methods and/or with changes to manufacturing process operations For the Blue Water program, interim DS Reference Standards will be established in accordance with an approved protocol from the DS Engineering lot(s). To reiterate the approach to DS Reference Standard, a minimum of 1,000 vials of Engineering DS will be aliquoted and qualified as the DS Reference Standard. The filled Engineering DP generated in Task 7 will be labelled and qualified as the DP Reference Standard. A QA-reviewed and approved Qualification Report will be provided that documents suitability of the DS and DP Reference Standards in the intended methods. These interim DS and DP Reference Standards are to be used for Phase 1/2 product lot release and stability testing. A list of deliverables for Task 5 is shown in Table 16. Table 16. Task 5 Deliverables Task Deliverable DS Engineering Report DS Engineering Stability Protocol/Report Finalized BOM Task 5: Engineering Run and Finalized CGMP batch record templates Stability Testing Finalized CGMP DS Specifications Engineering non-CGMP DS COA and MSDS Updated Tech Transfer Protocol (if needed) Engineering non-CGMP DS Products (two total) Task 6: OPTIONAL – CGMP Run and Stability Testing Table 17. Task 6 Technical Assumptions Technical Assumption(s) Ology Bio will use the CGMP WCB Ology Bio will perform one CGMP...
Reference Standard. The Parties acknowledge and agree upon the need for a Bulk Drug Substance reference standard. Manufacturer shall manufacture a Bulk Drug Substance reference standard that meets the Specifications in Exhibit C in all respects except for purity; the Bulk Drug Substance reference standard pursuant to this Sections 3.2(ii) shall meet the purity specification of [****]
Reference Standard. B6 Into a 200ml volumetric flask pipette 5ml of standard solution B and 95ml of 1% w/v hydrochloric acid.
Reference Standard. 1 Government of Newfoundland and Labrador Department of Transportation and works, Highway Design Division. .1 Traffic Control Manual (TCM), latest edition.
