Batch Production Clause Samples

Batch Production. (1) On his own responsibility the producer takes an obligation to plan, organize and realize production and quality assurance process in order to ensure complete quality inspection and its management and also there should be met the requirements of quality assurance set on a product or a service. (2) For each production operation within product realization or a service there should be performed a record / proof with aim to ensure its back traceability. In case there would be detected a failure it must be ensured tracing and tracking of failured parts / products / batches etc. The supplier should ensure all materials, parts, semi-products and final products to be labelled properly and stored in order to eliminate any potential confusion in order to ensure back traceability. The supplier must ensure readability of labelling on packaged products during transport and storage periods. (3) In case any process failure or deviation occur related to product quality, the supplier then should analyse causes and to establish a corrective measures and to control its effectivity (see Chapter No. 10). (4) All production operations at the product realization process must be performed by properly trained workers of the supplier. The supplier should be able to prove realized trainings and suitable qualifications for all individual workers (focussed on gained skills for a critical operations). (5) The supplier is recommended to follow EN 287-1, EN 287-2 or EN 473 standard requirements in order to keep specific qualifications of his workers.

Batch Production. PETNET will produce the Product in Batches and will dispense the Batches into doses for delivery to Authorized Trial Sites. A “

Batch Production. Avecia shall carry out production of two (2) Development Batches (in accordance with the terms set forth below) in its ABC5000 facility in accordance with the terms and conditions of this Agreement, cGMP, Applicable Laws and the Work Programme, with the primary aim of testing and improving Batch records and operating procedures, clarifying any scale-up issues and ensuring operator familiarity with the Process. Avecia also shall carry out an Engineering Batch in accordance with Clause 2.3(e). Whilst Development Batch Manufacture is intended to produce Development Batches which can be Released, it is recognised that problems related to the Process that are not Avecia Defaults may preclude this.

Batch Production a. Manufacture of Bulk Drug Substance b. QC Analytical testing Bulk Drug Substance c. QA review and disposition Bulk Drug Substance d. Environmental monitoring associated with customer specific process e. Suite support activities including but may not be limited to: i. Routine environmental monitoring ii. Support of utilities