Batch Designation and Documentation Sample Clauses

Batch Designation and Documentation. 6.1 Standard batch size shall be 13,000 liters or 2,600 5 liters bags (Pre-Mix Dialysate). 6.2 PISA shall designate a unique batch number for each batch of Product manufactured. Such number shall be used on all documentation relating to the particular batch. 6.3 PISA shall prepare for each batch of Product a Batch Record which shall con-tain at least the following details: (a) name and description of product (b) batch number (c) date of manufacture (determined as of the date of first mixing constitu-ent materials) (d) expiry date (determined on the basis of the shelf life as from date of manufacture) (to be indicated with six digits, e.g. 2005-04 = April, 2005) (e) size of batch and composition of product in the different stages of manufacture (f) results of in-process checks and controls (g) certification by persons responsible for each stage of manufacture that the manufacture is duly made in accordance with the manufacturing and test specifications, (h) special observations made during manufacture (i) lot or batch control numbers of raw materials and packaging materials used in the manufacture of the product batch (j) details of the type and number of batch samples. 6.4 The Batch Record may refer to other documentation regarding individual data. 6.5 In the event there occurs any significant deviation from specified or validated data or processes in the manufacture of the Products, such deviating data or process shall be fully explained and documented by PISA in an attachment, entitled "Remarks", to the Batch Record and be promptly forwarded to NxStage. Any deviation shall be justified and approved by PISA's Qualified Person and consented by NxStage prior to batch release, which consent shall not be unreasonably withheld. 6.6 Upon request, PISA shall promptly furnish NxStage with copies of full batch documentation. PISA shall retain original documentation for regulatory inspection compliance and shall make the documentation available for inspection by the competent regulatory authorities and NxStage.
AutoNDA by SimpleDocs

Related to Batch Designation and Documentation

  • Creation and Designation There is hereby created a tranche of Card Series Class A Notes to be issued pursuant to the Indenture, the Asset Pool 1 Supplement and the Indenture Supplement to be known as the “Card Series Class A(2019-2) Notes.”

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to: a. Records providing a full description of each activity undertaken; b. Records demonstrating that each activity undertaken meets the one of the National Objectives of the CDBG program; c. Records required to determine the eligibility of activities; d. Records required to document the acquisition, improvement, use, or disposition of real property acquired or improved with CDBG assistance; e. Records documenting compliance with the fair housing and equal opportunity components of the CDBG program; f. Financial records as required by federal regulations 24 CFR 570.502, and 24 CFR 84.21-28; and g. Other records necessary to document compliance with Subpart K of 23 CFR.

  • Pricing Instrument; Execution and Incorporation of Terms The parties hereto will enter into this Indenture by executing the Pricing Instrument. By executing the Pricing Instrument, the Indenture Trustee, the Registrar, the Transfer Agent, the Paying Agent, the Calculation Agent and the Trust hereby agree that the Indenture will constitute a legal, valid and binding agreement between the Indenture Trustee, the Registrar, the Transfer Agent, the Paying Agent, the Calculation Agent and the Trust. All terms relating to the Trust or the Notes not otherwise included herein will be as specified in the Pricing Instrument or Pricing Supplement, as indicated herein.

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. (b) The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. (c) The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer.

  • APPLICATION AND PARTIES BOUND 5.1 The parties bound by this Agency Specific Agreement are the Civil Service Association of WA Inc and the Director General of the Department of Racing, Gaming and Liquor. 5.2 This Agency Specific Agreement does not replace the General Agreement. 5.3 This Agency Specific Agreement shall apply to all employees who are members or eligible to be members of the Union and who are covered by the General Agreement and the Award. 5.4 This Agency Specific Agreement shall be read in conjunction with the Award and the General Agreement. 5.5 Except where the General Agreement identifies conditions as core, the Agency Specific Agreement will prevail over the General Agreement and the Award to the extent of any inconsistencies. 5.6 At the date of registration the approximate number of employees covered by this Agency Specific Agreement is 16.

  • Records and Documentation The Sub-Recipient agrees to make available to AAAPP staff and/or any party designated by the AAAPP any and all contract related records and documentation. The Sub-Recipient shall ensure the collection and maintenance of all program related information and documentation on any such system designated by the AAAPP. Maintenance includes valid exports and backups of all data and systems according to AAAPP standards.

  • Notification and Distribution of Materials The Company shall notify the Holders in writing of the effectiveness of the Resale Shelf Registration Statement as soon as practicable, and in any event within one (1) Business Day after the Resale Shelf Registration Statement becomes effective, and shall furnish to them, without charge, such number of copies of the Resale Shelf Registration Statement (including any amendments, supplements and exhibits), the Prospectus contained therein (including each preliminary prospectus and all related amendments and supplements) and any documents incorporated by reference in the Resale Shelf Registration Statement or such other documents as the Holders may reasonably request in order to facilitate the sale of the Registrable Securities in the manner described in the Resale Shelf Registration Statement.

  • Software and Documentation Licensee may make as many copies of the Software necessary for it to use the Software as licensed. Each copy of the Software made by Licensee must contain the same copyright and other notices that appear on the original copy. Licensee will not modify the Documentation. Documentation may: (a) only be used to support Licensee’s use of the Software; (b) not be republished or redistributed to any unauthorized third party; and (c) not be distributed or used to conduct training for which Licensee, or any other party, receives a fee. Licensee will not copy any system schema reference document related to the Software.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • LIMITATIONS ON REVERSE ENGINEERING, DECOMPILATION AND DISASSEMBLY You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!