Master Batch Sample Clauses

Master Batch process documentation will be prepared and approved by GalaGen as per its normal procedures. The Parties agree that deviations from master Batch process documentation may be necessary from time to time. Such deviations shall be discussed with Wyeth-Ayerst before any proposed shipment of the Ingredient. Individual Batch process documentation shall be photocopied from the approval master and issued for each Batch as per GalaGen's or its sub-contractor's routine system. Original Batch records will be filed securely by GalaGen or its sub-contractor. GalaGen or GalaGen's sub-contractor will perform all in-process control tests demanded by the approved Batch process.
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Master Batch. RECORD (MBR) shall mean the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained in ALTHEA’s standard format by AXXXXX, using CLIENT’s master formula and technical support.

Related to Master Batch

  • 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.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Management Plan The Management Plan is the description and definition of the phasing, sequencing and timing of the major Individual Project activities for design, construction procurement, construction and occupancy as described in the IPPA.

  • PERFORMANCE MANAGEMENT SYSTEM 6.1 The Performance Plan (Annexure A) to this Agreement sets out – 6.1.1 The standards and procedures for evaluating the Employee’s performance; and 6.1.2 The intervals for the evaluation of the Employee’s performance. 6.2 Despite the establishment of agreed intervals for evaluation, the Employer may in addition review the Employee’s performance at any stage while the contract of employment remains in force; 6.3 Personal growth and development needs identified during any performance review discussion must be documented in a Personal Development Plan as well as the actions agreed to and implementation must take place within set time frames; 6.4 The Employee’s performance will be measured in terms of contributions to the goals and strategies set out in the Employer’s Integrated Development Plan (IDP) as described in 6.6 – 6.12 below; 6.5 The Employee will submit quarterly performance reports (SDBIP) and a comprehensive annual performance report at least one week prior to the performance assessment meetings to the Evaluation Panel Chairperson for distribution to the panel members for preparation purposes; 6.6 Assessment of the achievement of results as outlined in the performance plan: 6.6.1 Each KPI or group of KPIs shall be assessed according to the extent to which the specified standards or performance targets have been met and with due regard to ad-hoc tasks that had to be performed under the KPI, and the score of the employer will be given to and explained to the Employee during the assessment interview. 6.6.2 A rating on the five-point scale shall be provided for each KPI or group of KPIs which will then be multiplied by the weighting to calculate the final score; 6.6.3 The Employee will submit his self-evaluation to the Employer prior to the formal assessment; 6.6.4 In the instance where the employee could not perform due to reasons outside the control of the employer and employee, the KPI will not be considered during the evaluation. The employee should provide sufficient evidence in such instances; and 6.6.5 An overall score will be calculated based on the total of the individual scores calculated above.

  • Emergency Mode Operation Plan Contractor must establish a documented plan to enable continuation of critical business processes and protection of the security of electronic County PHI or PI in the event of an emergency. Emergency means any circumstance or situation that causes normal computer operations to become unavailable for use in performing the work required under this Agreement for more than twenty-four (24) hours.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Work Order (s) means a detailed scope of work for a Service required by Transnet, including timeframes, Deliverable, Fees and costs for the supply of the Service to Transnet, which may be appended to this Agreement from time to time.

  • Substance Abuse Testing The Parties agree that it is in the best interest of all concerned to promote a safe working environment. The Union has no objection to pre-employment substance abuse testing when required by the Employer and further, the Union has no objection to voluntary substance abuse testing to qualify for employment on projects when required by a project owner. The cost and scheduling of such testing shall be paid for and arranged by the Employer. The Union agrees to reimburse the Employer for any failed pre-access Alcohol and Drug test costs.

  • Data Loss Prevention DST shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving DST’s control without authorization in place.

  • Data Storage Where required by applicable law, Student Data shall be stored within the United States. Upon request of the LEA, Provider will provide a list of the locations where Student Data is stored.

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