Batch Testing i. Dy. Director of Health Services (E&S), West Bengal and the heads of the direct demanding units and decentralized stores will be at liberty to get the items supplied tested at appropriate laboratory to verify the quality of the product. Such testing will be in addition to tests that may be done by any authority exercising statutory powers of surgical items/medical device testing. The Tenderer shall be bound to replace the defective batch(s) as per test report of either the non-statutory lab or the statutory lab with maintaining all provisions of Pollution Control Board. The cost of procurement of non-standard items will be deducted from the security deposit, Performance Bank Guarantee and/or from the pending bills of that supplier. Moreover, action will be taken under the relevant provision of Drugs and Cosmetics Act, 1940 and Rules made there under. In no circumstances request for replacement of non-standard medical devices or equipment by the suppliers will be entertained.
ii. A sum@ 2% of bills exclusive of Govt. tax & duties will be deducted from the bills of the supplies of items included in this tender by Central Medical Store/ all District Reserved Stores / other direct demanding units and deposited in the respective budget head to meet cost of handling and testing charges.
iii. Each installment of supply of items for which BIS/ IS/ISO or other standard has been prescribed must be accompanied the certificate.
Batch Testing. In the EU, as provided in Article 51 paragraph 2 of Directive 2001/83/EC of the European Parliament and of the Council (1) and in Article 55 paragraph 2 of Directive 2001/82/EC of the European Parliament and of the Council (2), the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.
Batch Testing. The PRD (temperature triggered) manufacturer shall institute a production batch inspection and acceptance testing programme that ensures consistent safety performance of the product.
Batch Testing. Certificate of Authenticity ------------------------------------------ INyX shall test, or cause to be tested, in accordance with the Product Specifications, each batch of Product manufactured pursuant to this Agreement before delivery to the Customer. Prior to each shipment of Product, INyX shall provide to the Customer a Certificate of Analysis attesting to the quality of each batch contained within the shipment, including review and approval by the appropriate quality control unit of all batch production and control records. INyX shall maintain and provide the Customer with such documentation as may be required for compliance with FDA and other applicable regulators.
Batch Testing. Optimer will have standard analytical testing performed on each Manufactured batch of Supplied Product to be shipped to Partner to verify that it meets the Product Specifications, according to the procedure described in the corresponding documentation and that the Supplied Product was Manufactured in accordance with Applicable Laws.
Batch Testing. Vical will perform standard analytical testing of each Manufactured batch of Compounds and/or Products to be delivered to Astellas to verify that each of them meets the Specifications according to the procedure described in the corresponding documentation and that Compounds and/or Products were Manufactured in accordance with Applicable Laws.
Batch Testing. FUSION shall have the right but not the obligation to conduct any Batch testing [***] or investigation it determines to be of value to determine compliance of Product with the Specifications and/or pursuant to any other standard imposed by law. A Batch shall be deemed to be acceptable if, upon testing, it meets the Specifications, relevant cGMP standards, all other applicable laws, rules and regulations (and any additional tests as agreed by the Parties). If either Party discovers that a Batch does not meet the Specifications, relevant cGMP standards or other applicable laws, rules or regulations, then the discovering Party shall promptly communicate with the other Party. All warranty obligations of CPDC with respect to a particular Batch shall cease and have no effect to the extent that any defect in such Batch arises from abuse, misuse, alteration, mishandling, improper storage or gross negligence by FUSION or FUSION’S employees, representatives, agents, suppliers or carriers, or defects in Precursor materials furnished by FUSION which are used in the production of such Batch.
Batch Testing. ARIAD shall have standard analytical testing performed on each batch of the Product to be shipped to Otsuka to verify that it meets the Specifications, according to the procedure described in the corresponding documentation, and ARIAD shall provide the results of such analytical testing to Otsuka.
Batch Testing. MannKind will have standard analytical testing performed on each Manufactured batch of Product to be shipped to Sanofi to verify that it meets Product Specifications, according to the procedure described in the corresponding documentation, and that Product was Manufactured in accordance with Applicable Laws.
Batch Testing. NovaDel will perform standard analytical testing of each Manufactured batch of Licensed Product to be delivered to BioAlliance to verify that it meets the Specifications, according to the procedure described in the corresponding documentation and that Licensed Product was Manufactured in accordance with applicable Regulatory Approvals, laws, rules, regulation and authorities prior to shipment of each batch of Licensed Product.
