Quality Control and Sampling Sample Clauses

Quality Control and Sampling. During Manufacture of Substance and Finished Product(s), SCHERING will draw representative samples according to cGMP. SCHERING will sample, store and maintain appropriate reserve samples (identified by Batch number) (the “Reserve Samples”) of (a) Finished Product, (b) all Substance used in the production of Finished Product, and (c) all key raw materials used to Manufacture Substance and Finished Product, in accordance with cGMPs and other US federal requirements including 21CFR211.170(b) and in each case with respect to quantities determined by accepted statistical procedures and stored under conditions and in the same immediate container-closure system as defined in the Specifications and applicable DMFs. The Reserve Samples shall also be visually inspected at least once a year for evidence of deterioration, recording the results of such inspection, as required by cGMP regulations, especially US federal regulation 21CFR211.170(b). Release testing will be performed according to the Specifications and applicable DMFs and to Testing Standards. Reserve Samples of Starting Materials will be stored until at least one year after the expiration date of the last Batch of the Finished Product produced from them. Reserve Samples of every Batch of Finished Product shall be kept for one year after the expiration date of the respective Batch and in sample quantities of at least twice the quantity necessary for testing to determine whether Substance in the Finished Product meets its established Specifications as defined in the NDA and applicable DMFs, and as required by cGMP regulations, especially US federal regulation 21CFR211.170(a). SCHERING shall provide INDEVUS and any Regulatory Authority with reasonable access to and portions of the Reserve Samples for testing and other purposes upon reasonable request of INDEVUS.
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Quality Control and Sampling. 10.1 During Processing of Product, BIO HOSPITAL shall draw representative samples according to cGMP.
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Quality Control and Sampling. During manufacture of the Bulk Product NexMed will ensure to perform the tests according to the Testing Standards and Quality Specifications and will draw samples for testing and reserve samples. Reserve samples consists of at least twice the quantity necessary to perfom all the requiered tests. The reserve samples of starting and packaging materials will be stored until at least one year after the expiration date of the last batch of the Bulk Product produced of them. The samples of every batch of a Bulk Product shall be kept for one year after the expiration date of the respective batch. The reserve samples will be transferred to Schering on request. NexMed may draw additional reserve samples for his own use. All these samples shall be maintained at the disposal of the competent authorities.
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Quality Control and Sampling. During Manufacture of Device Medicom will perform appropriate tests set forth in Delivery Specification (Appendix 2) to ensure compliance with the applicable Regulations.
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Related to Quality Control and Sampling

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time. B. Controlled Affiliate agrees to comply with all applicable federal, state and local laws. C. Controlled Affiliate agrees that it will provide on an annual basis (or more often if reasonably required by Plan or by BCBSA) a report or reports to Plan and BCBSA demonstrating Controlled Affiliate’s compliance with the requirements of this Agreement including but not limited to the quality control provisions of this paragraph and the attached Exhibit A. D. Controlled Affiliate agrees that Plan and/or BCBSA may, from time-to-time, upon reasonable notice, review and inspect the manner and method of Controlled Affiliate’s rendering of service and use of the Licensed Marks and Name. E. As used herein, a Controlled Affiliate is defined as an entity organized and operated in such a manner, that it meets the following requirements: (1) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), must have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having not less than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate at least equal to that exercised by persons or entities (jointly or individually) other than the Controlling Plan(s); and Notwithstanding anything to the contrary in (a) through (b) hereof, the Controlled Affiliate’s establishing or governing documents must also require written approval by the Controlling Plan(s) before the Controlled Affiliate can: (i) change its legal and/or trade names; (ii) change the geographic area in which it operates; (iii) change any of the type(s) of businesses in which it engages; (iv) create, or become liable for by way of guarantee, any indebtedness, other than indebtedness arising in the ordinary course of business; (v) sell any assets, except for sales in the ordinary course of business or sales of equipment no longer useful or being replaced; (vi) make any loans or advances except in the ordinary course of business; (vii) enter into any arrangement or agreement with any party directly or indirectly affiliated with any of the owners or persons or entities with the authority to select or appoint members or board members of the Controlled Affiliate, other than the Plan or Plans (excluding owners of stock holdings of under 5% in a publicly traded Controlled Affiliate); (viii) conduct any business other than under the Licensed Marks and Name; (ix) take any action that any Controlling Plan or BCBSA reasonably believes will adversely affect the Licensed Marks and Name. In addition, a Plan or Plans directly or indirectly through wholly owned subsidiaries shall own at least 50% of any for-profit Controlled Affiliate. (2) A Plan or Plans authorized to use the Licensed Marks in the Service Area of the Controlled Affiliate pursuant to separate License Agreement(s) with BCBSA, other than such Controlled Affiliate’s License Agreement(s), (the “Controlling Plan(s)”), have the legal authority directly or indirectly through wholly-owned subsidiaries to select members of the Controlled Affiliate’s governing body having more than 50% voting control thereof and to: (a) prevent any change in the articles of incorporation, bylaws or other establishing or governing documents of the Controlled Affiliate with which the Controlling Plan(s) do(es) not concur; (b) exercise control over the policy and operations of the Controlled Affiliate. In addition, a Plan or Plans directly or indirectly through wholly-owned subsidiaries shall own more than 50% of any for-profit Controlled Affiliate.

  • Quality control system (i) The Contractor shall establish a quality control mechanism to ensure compliance with the provisions of this Agreement (the “Quality Assurance Plan” or “QAP”). (ii) The Contractor shall, within 30 (thirty) days of the Appointed Date, submit to the Authority’s Engineer its Quality Assurance Plan which shall include the following: (a) organisation, duties and responsibilities, procedures, inspections and documentation; (b) quality control mechanism including sampling and testing of Materials, test frequencies, standards, acceptance criteria, testing facilities, reporting, recording and interpretation of test results, approvals, check list for site activities, and proforma for testing and calibration in accordance with the Specifications for Road and Bridge Works issued by MORTH, relevant IRC specifications and Good Industry Practice; and (c) internal quality audit system. The Authority’s Engineer shall convey its approval to the Contractor within a period of 21 (twenty-one) days of receipt of the QAP stating the modifications, if any, required, and the Contractor shall incorporate those in the QAP to the extent required for conforming with the provisions of this Clause 11.2. (iii) The Contractor shall procure all documents, apparatus and instruments, fuel, consumables, water, electricity, labour, Materials, samples, and qualified personnel as are necessary for examining and testing the Project Assets and workmanship in accordance with the Quality Assurance Plan. (iv) The cost of testing of Construction, Materials and workmanship under this Article 11 shall be borne by the Contractor.

  • Quality Control Program Engineer shall have a quality control program in place that ensures that all deliverable work is of high quality. Engineer shall submit a plan detailing its program to the Inspection Branch of the TxDOT Bridge Division for review and approval prior to beginning work. State may review or audit the programs.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Quality Control Procedures The Seller shall have an internal quality control program that verifies, on a regular basis, the existence and accuracy of the legal documents, credit documents, property appraisals, and underwriting decisions. The program shall include evaluating and monitoring the overall quality of the Seller's loan production and the servicing activities of the Seller. The program is to ensure that the Mortgage Loans are originated and serviced in accordance with Accepted Servicing Standards and the Underwriting Guidelines; guard against dishonest, fraudulent, or negligent acts; and guard against errors and omissions by officers, employees, or other authorized persons.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Use; Quality Control a. Neither party may alter the other party’s trademarks from the form provided and must comply with removal requests as to specific uses of its trademarks or logos. b. Each party agrees to use, and to cause its Permitted Sublicensees to use, the other party’s trademarks only in good faith and in a dignified manner consistent with such party’s use of the trademarks. Upon written notice to the breaching party, the breaching party has 30 days of the date of the written notice to cure the breach or the license will be terminated.

  • Compliance Control Services (1) Support reporting to regulatory bodies and support financial statement preparation by making the Fund's accounting records available to the Trust, the Securities and Exchange Commission (the “SEC”), and the independent accountants. (2) Maintain accounting records according to the 1940 Act and regulations provided thereunder. (3) Perform its duties hereunder in compliance with all applicable laws and regulations and provide any sub-certifications reasonably requested by the Trust in connection with any certification required of the Trust pursuant to the Xxxxxxxx-Xxxxx Act of 2002 (the “SOX Act”) or any rules or regulations promulgated by the SEC thereunder, provided the same shall not be deemed to change USBFS’s standard of care as set forth herein. (4) Cooperate with the Trust’s independent accountants and take all reasonable action in the performance of its obligations under this Agreement to ensure that the necessary information is made available to such accountants for the expression of their opinion on the Fund’s financial statements without any qualification as to the scope of their examination.

  • WORKPLACE HEALTH AND SAFETY The parties to this Agreement are committed to providing a safe and healthy workplace and work practices. The parties recognise that illness or injury at the workplace is costly to the employer and the employees and also disruptive to the respective parties. To facilitate healthy and safe work practices, the parties to the Agreement are committed to discussing health and safety issues as they apply to the operations of the employer as part of the consultative measures under this Agreement. The employer and employees under this agreement may refer to their respective industrial representatives for appropriate advice or expertise in enhancing performance with due regard to health and safety initiatives. The parties also recognise the importance of conducting regular audits of the employer's operations, policies and procedures including the employees' skills, knowledge, qualifications and application of healthy and safe work practices.

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