Analytical Methods Validation Sample Clauses

Analytical Methods Validation. These activities should start at least 6 months before the first batch of validation. · Validation of analytical methods : · Acetate and Trifluoroacetate content in API € [*] · Water content € [*] · GC-Headspace (complement to general method) € [*] · Direct GC (complement to general method) € [*]* · Specific rotation € [*] · Peptide content (Nitrogen) € [*] · HPLC for in-process control upstream and downstream (3 methods). Need for HPLC methods will be discussed with Radius. · HPLC for in-process control downstream : 2 methods (FG1 and VG1) € [*] each method · HPLC for in-process control upstream : 3 methods: loading € [*], short method cleavage € [*], long method cleavage € [*] LC-MS analysis by TG1 method: € [*] per sample Comparability report: € [*] Sequencing by ES/MS/CAD/MS: € [*] for 2 samples Amino acid analysis: € [*] for 2 samples Limit test for residual amino acids: € [*] for 2 samples Secondary counter ions: € [*] for 2 samples € [900]* per test sample (same method as for lot 4AI1) + $ [*] for specific method validation (Sn, Cr, Hg, Pb, As, Cd per ICH guidelines) Solubility: € [*] per test sample pH: € [*] per test sample isoelectric point: € [*] per test sample
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Analytical Methods Validation. These activities should start at least 6 months before the first batch of validation. · Validation of analytical methods : · Acetate and Trifluoroacetate content in API € 12,000 · Water content € 5,000 · GC-Headspace (complement to general method) € 12,000 · Direct GC (complement to general method) € 12,000 · Specific rotation € 3,000 · Peptide content (Nitrogen) € 6,000 · HPLC for in-process control upstream and downstream (3 methods). Need for HPLC methods will be discussed with Radius. · HPLC for in-process control downstream : 2 methods (FG1 and VG1) € 3,000 each method · HPLC for in-process control upstream : 3 methods: loading € 4,000, short method cleavage € 6,000, long method cleavage € 8,000 · LCMS comparability: LC-MS analysis by TG1 method: € 800 per sample Comparability report: € 500 · reference standard [assuming 2 lots and 250mg of each minimum] Sequencing by ES/MS/CAD/MS: € 3000 for 2 samples Amino acid analysis: € 1600 for 2 samples Limit test for residual amino acids: € 1600 for 2 samples Secondary counter ions: € 1000 for 2 samples · Heavy metals (USP/EP level) € 900 per test sample (same method as for lot 4AI1) + $ 22,500 for specific method validation (Sn, Cr, Hg, Pb, As, Cd per ICH guidelines) · General properties: Solubility: € 175 per test sample pH: € 150 per test sample isoelectric point: € 275 per test sample
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Analytical Methods Validation. 1. AUXILIUM shall be responsible at its cost for analytical methods validation for drug substance and drug product.
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Related to Analytical Methods Validation

  • Validation In respect to applications for leave made pursuant to this Article, the employee may be required to provide satisfactory validation of the circumstances necessitating such requests.

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.