Cleaning Verification/Validation Clause Samples

The Cleaning Verification/Validation clause establishes requirements for confirming that cleaning processes meet specified standards or regulatory requirements. Typically, this involves documented procedures for testing and inspecting equipment, surfaces, or environments after cleaning to ensure the removal of contaminants or residues. This clause is essential for industries such as pharmaceuticals, food production, or healthcare, where inadequate cleaning can lead to safety risks or regulatory non-compliance. Its core function is to ensure product safety and regulatory adherence by providing a systematic approach to verifying the effectiveness of cleaning activities.
Cleaning Verification/Validation. LONZA is responsible for ensuring that adequate cleaning is carried out between lots of different product to prevent contamination. Data should be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of the same product. ORPHAN will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) to establish cleaning limits. The cleaning procedure and analytical methodology will be reviewed before the first product lots are made.
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Cleaning Verification/Validation. ▇▇▇▇▇▇ is responsible for ensuring that adequate cleaning of product contact parts used in the manufacture of Product is carried out between batches of different product to prevent contamination. Halozyme will provide information (i.e. LD50, toxicity, solubility, batch size, fill volume, product max human dose (MHD) for the Initial Drug (as defined in the Development and Supply Agreement), to establish cleaning limits. Until such time as the cleaning procedure and analytical methodology is validated for the Initial Drug, Halozyme will purchase new product contact equipment; including but not limited to, glass receiving vessels and filling needles, to be used in the manufacture of all Product batches.
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Cleaning Verification/Validation. 7.3.1 Avecia is responsible for ensuring that adequate cleaning verification of product contact parts used in the manufacture of Stressgen QA API is carried out between batches of different products to prevent cross-contamination. 7.3.2 Stressgen QA will provide information (solubility, toxicity, dose etc.) to establish cleaning limits.
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Related to Cleaning Verification/Validation

  • Third Party Verification 4.8.1 The SPD shall be further required to provide entry to the site of the Power Project (from which power under this Agreement is being made available) free of all encumbrances at all times during the Term of the Agreement to SECI and a third Party nominated by any Indian Governmental Instrumentality for inspection and verification of the works being carried out by the SPD at the site of the Power Project. The SPD shall provide full support to SECI and/or the third party in this regard. 4.8.2 The third party may verify the construction works/operation of the Project being carried out by the SPD and if it is found that the construction works/operation of the Power Project is not as per the Prudent Utility Practices, it may seek clarifications from SPD or require the works to be stopped or to comply with the instructions of such third party.

  • E-VERIFICATION The Vendor represents and warrants that it will ensure its compliance with the Mississippi Employment Protection Act of 2008, and will register and participate in the status verification system for all newly hired employees. Mississippi Code Annotated §§71-11-1 et seq. The term “employee” as used herein means any person that is hired to perform work within the State of Mississippi. As used herein, “status verification system” means the Illegal Immigration Reform and Immigration Responsibility Act of 1996 that is operated by the United States Department of Homeland Security, also known as the E-Verify Program, or any other successor electronic verification system replacing the E-Verify Program. Vendor agrees to maintain records of such compliance. Upon request of the State and after approval of the Social Security Administration or Department of Homeland Security when required, Vendor agrees to provide a copy of each such verification. Vendor further represents and warrants that any person assigned to perform services hereafter meets the employment eligibility requirements of all immigration laws. The breach of this agreement may subject Vendor to the following: termination of this contract for goods or services and ineligibility for any state or public contract in Mississippi for up to three (3) years with notice of such cancellation/termination being made public; the loss of any license, permit, certification, or other document granted to Vendor by an agency, department or governmental entity for the right to do business in Mississippi for up to one (1) year; or,

  • 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.

  • Medical Verification The Town may require medical verification of an employee’s absence if the Town perceives the employee is abusing sick leave or has used an excessive amount of sick leave. The Town may require medical verification of an employee’s absence to verify that the employee is able to return to work with or without restrictions.

  • Random Testing Notwithstanding any provisions of the Collective Agreement or any special agreements appended thereto, section 4.6 of the Canadian Model will not be applied by agreement. If applied to a worker dispatched by the Union, it will be applied or deemed to be applied unilaterally by the Employer. The Union retains the right to grieve the legality of any imposition of random testing in accordance with the Grievance Procedure set out in this Collective Agreement.