Purchasing documents meaning

REIMBURSABLE DEVELOPMENT EXPENSES shall mean all internal and external direct, actual and documented costs incurred by Origin8or after the Effective Date to develop the Oral Formulation of the Product, including, without limitation, pre-dinical and clinical trial expenses (including, without limitation, the direct cost of clinical trial materials), reasonable Third Party costs, Regulatory Approval expenses and fees, and costs associated with scientific personnel dedicated to development of the Oral Formulation of the Product, where scientific personnel costs shall be calculated at a rate of Two Hundred Thousand Dollars ( 200,000) per FTE. The purchase of raw materials or supplies or external Third Party services shall be calculated using actual direct costs incurred by the Parties for such Third Party goods or services. 

The principle for the documentation trail and qualification process surrounding the purchase installation of equipment is a matter of common sense. The following terms are by no means universal but the principle and elements of these are essential to meeting cGMP. 

The option to produce a home mix feed has appeal but the reality is different. So much of the health of any animal depends on the quality, quantity and nutritional balance of the feed that the days of scattering a handful of wheat, organic or not, and allowing the bird to forage for the remainder of its diet have gone. There will always be those who say that they achieve success by this means, but our belief is it is far better to purchase feed from a registered organic feed supplier than to mix a home produced feed. A compounded feed contains a mix of raw materials with documented and traceable supply routes, and a mineral-vitamin balance that will ensure the health of the chickens. 

If the purchase of video equipment for the documentation of TLC plates is under consideration, it is advisable only to reconrmend the current best solution, which must necessarily be expensive. Otherwise, do not become involved At the present time, the best solution means at least a 3-chip camera and a PC with a Pentium II processor, with Windows XP as the operating system. 

The future control of the product and pack then revolves around these documents. In the case of a plastic pack or plastic components, it may be necessary not only to define certain critical factors in the specification tightly, but also to purchase under a certificate of warranty, as exhaustive QC procedures (particularly biological tests), which might be necessary to detect change, could involve prohibitive costs. Regular QC checks are likely to include melt flow index, density, IR or DSC identity, etc. The last two are a particularly useful means of providing plastic identification, with DSC now more widely used. 

HR moulds are for use in mass production, i.e., continuous operation, and the high cost of any downtime must be considered. Only highly-skilled staff may be involved in work with these kinds of moulds. Supervisory staff must be familiar with the mould documentation to be able to identify the HR system used and adapt process instructions to it. This also means that when a ready-made mould is purchased, the contract must insist on supply of full technical documentation and process instructions for use. 

The physical essence of traceability is the cross-referencing between documents and from documents to the corresponding materiel and works. This means a traceability trail has to be established that can be followed linking all elements concerned. The level of traceability required must be defined as early as possible in writing and must be a contractual requirement in the purchase orders and construction contracts concerned. Special care must be taken to ensure that authority traceability exigencies are incorporated right from the start. Specified requirements should not be exceeded. Excessive zeal in this direction is unnecessary, wastes money, can create frustration and diminishes the credibility of the mandatory requirements for traceability. 

All rights reserved. This book may not be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage and retrieval systems, without permission in writing from the Publisher. THE PUBLISHER HEREBY GRANTS PERMISSION FOR THE INCLUSION OF INDIVIDUAL ILLUSTRATIONS IN THIS WORK AS PART OF WORK STUDIES AND PROJECT DOCUMENTATION BY THE PURCHASER. 

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