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. 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. (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. 11.1 BIO HOSPITAL shall sample, store and maintain appropriate reserve samples (identified by Batch number) (the “Reserve Samples”) of (i) Product and (ii) all Raw Materials used to Process or package Product, in accordance with cGMP and other US federal requirements including 21 CFR 211.170 (b), and in each case with respect to quantities as set forth in the Specifications attached hereto and stored under conditions and in the same immediate container-closure system as defined in the Specifications. If additional reserve samples are required the parties will jointly determine and agree upon what additional cost is appropriate to store such samples in excess of the current Specifications. Reserve Samples of Product from each batch of Product to permit at least two (2) full re-examinations. Reserve Samples of each batch of Product shall be retained for at least two (2) years after the expiration date of the respective batch. BIO HOSPITAL shall notify OCEANA that Product is approaching expiration and if OCEANA requests the Reserve Samples, OCEANA shall inform BIO HOSPITAL where the Reserve Samples shall be sent. The Reserve Samples shall be visually inspected by BIO HOSPITAL at least once a year for evidence of deterioration. BIO HOSPITAL shall record the results of such inspection, as required by cGMP regulations, especially US federal regulation 21 CFR 211.170 (b). BIO HOSPITAL shall provide OCEANA and any Regulatory Authority with reasonable access to any portions of the Reserve Samples for testing and other purposes upon OCEANA’ request.
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.
Reserve Samples. CLIENT shall be responsible for obtaining and maintaining sufficient quantities of Company Plasmid DNA reserve samples in accordance with cGMP.
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. Lilly will maintain reserve samples to comply with the Code of Federal Regulations 21 CFR 211.170 for the Products. Samples from Product lots tested for release at Lilly facilities will be maintained in a secure Lilly storage facility consistent with the storage conditions for the Products.
Reserve Samples. EZEM shall retain under proper storage conditions a representative samples of active ingredients and Drug Product as required to comply with Retain Sample Requirements in 21 CFR 211.170 and/or Application Commitments (where applicable) but in all events EZEM will assure compliance with the Regulations.
