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.
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. POINT shall have the right but not the obligation to conduct any Batch testing (at its own expense) 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 POINT or POINT’s employees, representatives, agents, suppliers or carriers, or defects in Precursor materials furnished by POINT which are used in the production of such Batch.
Batch Testing. Xxxxxx Xxxxx will perform standard analytical testing of each manufactured batch to be delivered to Cypress hereunder to verify that it Conforms according to the procedure described in the corresponding documentation or as required by applicable laws, regulation and authorities prior to shipment of each batch of Bulk API.
Batch Testing. The Third Party Manufacturer shall perform analytical testing of each manufactured batch of the Product to be delivered to DARA, using the regulatory approved analytical methods and the Specifications, to verify that it meets its release Specifications, as required by the FDA Rules prior to release of each batch of such Product. In addition, the Third Party Manufacturer shall perform testing of bulk in-process Product in accordance with the NDA and applicable FDA Rules. For the purposes of this Supply Agreement, the term “FDA Rules” means any and all applicable laws, statutes, rules, regulations, standards, policies, orders or other requirements promulgated or subject to enforcement, regulation or administration by the United States Food and Drug Administration (the “FDA”), all as amended or modified from time to time, and includes, but is not limited to, current Good Manufacturing Practice regulations of the FDA as set forth in Title 21 of the U.S. Code of Federal Regulations §§ 210 and 211 (“cGMPs”). CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS ([***]) DENOTE SUCH OMISSIONS. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMMITTED INFORMATION.
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.
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.
