CONTROLLED DOCUMENTS Sample Clauses

CONTROLLED DOCUMENTS. Paper or electronic documents that are part of the quality system and contain data/information required by cGMPs. These documents may also be referred to as GMP documents. Such documents must be initiated and revised through document control and/or change control procedures. Examples of controlled documents are: SOPs, analytical test methods, specifications, batch records, validation protocols, forms, etc.

CONTROLLED DOCUMENTS. 2.3.1 INyX manufacturing and analytical documentation practices shall be subject to frequent review by both parties to ensure compliance with the most current recognized interpretation of cGMPs for the appropriate phase of Product development or commercial manufacturing. 2.3.2 Standard operating procedures, specifications, test methods, and Master Batch Production Records shall be consistent with the ANDA filing and any subsequent supplements 2.3.3 Stiefel and INyX shall be jointly responsible for the approval of controlled documents (specifications, test methods, stability protocols, batch records, etc.) will be established and approved for use. 2.3.4 Stiefel shall provide all necessary source data to facilitate the completion of relevant specifications, etc. INyX shall provide for review and signature approval by Stiefel for the following documents prior ▇▇ implementation, and any subsequent changes must be made in accordance with the change control procedures set forth in Section 2.4: o Master Production Records o Specifications for Finished Product, Active Ingredient(s), Excipients, primary containers, and labeling materials. o Test methods for active drug substance, intermediate and Finished Product, cleaning evaluation o Stability protocols and monographs o Process validation and cleaning validation protocols and reports o Test methods validation protocols and reports o Technical protocols and reports specifically relating to Stiefel Products

CONTROLLED DOCUMENTS. Venture shall maintain all product specifications and product documentation, including Product Specifications, Process Management Plan, Quality Management Plans, and Product Addenda, as "controlled documents" according to Iomega's DCN procedure as provided to Venture. Duplicate copies of these documents shall be maintained at both Venture's and Iomega's facilities. Except as permitted under Section 4.6(b) (By Venture), Venture may not alter any of these controlled documents without the prior written approval of Iomega, which approval shall not be unreasonably withheld or delayed.

CONTROLLED DOCUMENTS. All documents used in the production of the Product, from the receiving of raw material to the releasing of the Product are considered controlled documents. Controlled documents consist of the following: receiving documents, test methods, including in-process methods, SOPs, specifications, including in-process specifications, production records, batch records, testing data/records, product reports and protocols, stability protocols and stability reports, and all product support documents. These shall be under revision control (as appropriate) and shall be filed in such a manner as to be traceable. Current SOPs and test methods will be readily accessible to production personnel or QC chemists.

CONTROLLED DOCUMENTS. 9.1 AMGEN shall make readily available to STANFORD, upon request, only documents related to lots supplied to STANFORD which shall include lot release documentation, summaries of change controls, complaint investigations, deviation/ nonconformances summaries, and stability data, as agreed between the Parties. AMGEN shall make batch records readily available during audits, and provide redacted sections of batch records upon request by STANFORD. 9.2 AMGEN shall retain controlled documents related to manufacturing and analytical data per AMGEN’s established procedures and cGMP requirements.

CONTROLLED DOCUMENTS. 9.1. Supplier shall maintain a document control process. 9.2. Controlled documents consist of, but are not limited to: 9.2.1. Receiving/Shipping Documents 9.2.2. Standard Operating Procedures 9.2.3. Specifications 9.2.4. Process Batch/Manufacturing Records 9.2.5. Product Protocols and Reports 9.2.6. Records of Change Control 9.2.7. Product and Process Validation Records

CONTROLLED DOCUMENTS. 4.1 All documents used in the Processing of non-sterile Product are maintained in accordance with applicable Sterigenics policies and procedures. 4.2 Controlled documents consist of, but are not limited to: ● Receiving/Shipping Documents ● Standard Operation Procedures (“SOPs”) ● Specifications ● Process Batch/Manufacturing Records ● Product Reports and Protocols ● Product Support Documents such as copies of change control and investigations ● Product Process Validation Records

CONTROLLED DOCUMENTS. None of various provisions of this Agreement shall be construed as providing for the release of reports or other information designated as "Classified" or "Unclassified Controlled Nuclear Information" (UCNI) to the Tribes, or waiving any other security requirements. Classified information includes National Security Information (10 CFR Part 1045) and Restricted Data (10 CFR Part 1016). Unclassified Controlled Nuclear Information is described in 10 CFR Ch. X, Part 1017. In the event that information requested under the provisions of this Agreement is determined by DOE to be exempt from disclosure under the Freedom of Information Act, providing the information is not Classified or UCNI, is not controlled by the Privacy Act, and does not contain proprietary information or intellectual property information, DOE may, to the

CONTROLLED DOCUMENTS. “Controlled Documents” shall mean the master batch record, SOPs and other quality-controlled documents applicable or referenced for the Manufacture of Product.