Reserve Samples. CLIENT shall be responsible for obtaining and maintaining sufficient quantities of Bulk Drug Substance and Drug Product reserve samples pursuant to cGMP.
Reserve Samples. (IATF 16949: Chapter 8.5.1.1) Reserve samples - at least three and undamaged - are kept safe by the SUPPLIER and protected against environmental influences. If the color, appearance or surface are relevant to the CLIENT’s processes, the reserve samples shall apply as reference (e.g. laser welding: laser light transmittance).
Reserve Samples. Each party shall perform its respective obligations with respect to retention and reserve sample in accordance with the applicable provisions of the Quality Agreement.
Reserve Samples. Client shall be responsible for obtaining and maintaining sufficient quantities of Client Product reserve samples in accordance with cGMP and the Specifications.
Reserve Samples. CLIENT shall be responsible for obtaining and maintaining sufficient quantities of Company Plasmid DNA reserve samples in accordance with cGMP.
Reserve Samples. Laureate shall maintain reserve samples of Product, under appropriate environmental conditions, in concurrence with Product labeling if so provided in the Supply Agreement. The number of reserve samples shall be sufficient to perform all release tests twice except for sterility, BET and the identification of objectionable microorganisms. The numbers of reserve samples per batch shall be specified in the manufacturing batch record. Reserve samples will be held for a minimum of one year after Product expiration date provided the terms of the Supply Agreement continue to be honored. Upon completion of the terms of the Agreement, Laureate will aid Cytogen in the transfer of reserve samples. Reserve samples of the active and inactive ingredients used in the manufacture of Product will be maintained in quantities similar to that for Product. Active ingredients will be held for a minimum of three years after receipt, or as specified above. Inactive ingredients will be held a minimum of two years after receipt. If any ingredient is retested (to extend expiration past one year) a new reserve sample will be pulled and held with written approval from both companies. Solvents, which do not appear in the final formula, compressed gases and water, are not retained. All reserve samples will be inspected visually on an annual basis provided the terms of the Supply Agreement are in effect.
Reserve Samples. Reserve samples shall be maintained by Sovereign according to cGMP requirements and internal procedures.
Reserve Samples. LTS shall keep retention samples of raw materials as required by LTS’s SOPs and Regulatory Requirements. LTS shall commit itself to keep reserve samples of drug product for regulatory purposes for each batch of drug product produced. If batches are reworked and/or reprocessed additional retention samples will be collected and retained by LTS. The quantity of critical intermediate and drug product retained should be at least three times the amount to be able to perform all physical and chemical tests according to the Certificate of Analysis.
Reserve Samples. 6.4.1 CATALENT will store and inspect retain samples of PRODUCT, API, and EXCIPIENTS according to CATALENT SOPs. The amount of sample retained will be at least twice the quantity required to carry out all of the tests required to determine if the material meets its SPECIFICATIONS.
Reserve Samples. Formosa shall keep retention samples of raw materials as required by [***] SOPs and Regulatory Requirements under the recommended storage conditions or better. Formosa shall keep retention samples of regulatory starting materials, intermediates (where applicable) and drug substance as required by Regulatory Requirements, for each batch of API produced. The quantity of starting materials and intermediates should be [***] the amount required to perform all physical and chemical tests according to the specification. Intermediate samples need to be held until the final API has been released by NGX. The quantity of API retained should be at least [***] the amount to be able to perform all physical and chemical tests according to the Certificate of Analysis. Formosa will visually inspect all retain samples annually and inform NGX within [***] if any unusual observations are made during the inspections.
