Retention Samples definition

Retention Samples. A fully packaged unit from a batch of finished Product stored for identification purposes. AMGEN Quality Specifications AMGEN approved set of analytical methods, requirements, and limits as used to judge the identity, purity and potency of all source materials, raw materials, and finished filled, labeled and packaged Product which comprises the Product. Stock Recovery The removal or correction of a non-marketed product used in a clinical trial for reasons related to product Safety, Quality, Identity, Potency, or Purity, that has not been marketed or that has not left the direct control of PARTNER.
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Retention Samples shall have the meaning set forth in Section 6.3.
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Retention Samples. A Sample of a fully packaged unit from a lot of finished product which is stored for identification purposes, or in case additional QC testing is necessary.
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Examples of Retention Samples in a sentence

  • Retention Samples A fully packaged unit from a batch of finished Product stored for identification purposes.

  • Retention Samples A fully packaged unit from a batch of Drug Product.

  • Sellers also agree that Buyers shall have reasonable access to all Retention Samples and Batch Records retained by Sellers for a period of one (1) year beyond any expiration date pertaining to any applicable Products, but only to the extent not needed by Sellers.

  • VIFOR or its subcontractors shall properly store and retain (i) Reference Samples of Starting Materials released for and used to Manufacture Product (except water, compressed gases and highly volatile substances), (ii) Reference Samples of Bulk Product and (iii) Retention Samples of Product in conditions and quantity consistent with GMP.

  • Supplier shall provide Adolor with reasonable access to and portions of the File Retention Samples for testing and other purposes upon Adolor’s request.

  • All Mylan’s costs with respect to the Retention Samples shall be included in Cost of Goods.

  • CyDex shall provide Prism with reasonable access to and portions of the File Retention Samples for testing and other purposes upon Prism’s request.

  • AVECIA will notify CUSTOMER before disposing of any Retention Samples, and CUSTOMER will have the option of having such Retention Samples delivered to CUSTOMER or its designee.

  • During any period Mylan manufactures the Product, Mylan shall be responsible for properly storing and retaining appropriate samples (identified by batch number) of the Product that it supplies to Forest in conditions and for times consistent with all applicable regulatory standards and to permit appropriate or required internal and regulatory checks and references (collectively, "Retention Samples").

  • Upon CUSTOMER’s request, AVECIA will provide CUSTOMER reasonable access to such Retention Samples without additional charge.