Suppliers approved

Even though full GMP compliance may begin later than receipt of raw materials, it is important to treat raw materials in a GMP compliant manner. Raw materials should be purchased only from suppliers approved by the Quality Unit. For raw materials whose quality is important to conformance of the excipient to compendial or specification requirements, or to performance expectations, the supplier approval process should be a combination of site visit and an evaluation of raw material quality. For other raw materials, it would be adequate to confirm that the raw material supplier can meet the purchasing specification. 

MAWP is typically set pressure and is determined by the pressure vessel supplier, approved by a notified body. 

The starting materials as well as the packaging materials should be purchased from qualified vendors. It is recommended to use materials described in a pharmacopoeia, whenever this is available. Supplier approval should include an evaluation that provides adequate assurance that the material consistently meets specifications. 

Quality control in the upstream supply chain is part of our supplier approval system and regular supplier auditing. The applied control systems are based, as within our own factory premises on the HACCP systems (Hazard Analysis on Critical Control Points). These quality control systems have been elaborated for each individual raw material. It is our objective to source our raw materials as far as possible from approved suppliers these are suppliers who are able to guarantee the qualities we require. 

Step Five To ensure we capture any substances that we purchase from new suppliers, every new supplier is asked if they have registered the substance for our intended use, under REACH. This question is asked as part of our supplier approval process. A new supplier is not approved, until they can provide evidence of compliance with the REACH regulation. 

A toller may need to use resources outside their company to measure physical properties, conduct safety or other testing, engineer changes to piping or other facilities and equipment. This need frequently occurs for products in the initial development or commercialization stage. The toller should maintain confidentiality agreements with their suppliers and subcontractors commensurate with the proprietary nature of their client companies processes. Provision to allow disclosure of information to third parties should be addressed in the contract between the toller and the client. It may be structured so that the client must approve the toller s release of information to third parties. 

All communication with suppliers shall be with the approval of the purchasing authority... 

The standard requires the supplier to comply with a product and process approval procedure recognized by the customer. 

Your subcontractors may not need to supply product approval submissions for all parts they supply but there are situations where subcontractor product approval submissions are required. For example, GM requires product approval of all commodities supplied by subcontractors to first tier suppliers. The standard does point out that suppliers are... 

The standard requires all design changes to be reviewed and approved bp authorized personnel before their implementation (including changes to proprietary designs). The standard also requires the supplier to address the impact of a design change on the systems in which the product is used, the customer assembly process, and other related products and systems. 

The standard requires suppliers to purchase products, materials, or services from approved subcontractors where specified bp the contract... 

This requirement does not mean that you need to maintain a list of approved suppliers. You should monitor the performance of all your subcontractors and suppliers and classify each according to prescribed guidelines. It is equally important that you list those... 

The standard requires the supplier to review and approve purchasing documents for adequacy of specified requirements prior to release. 

Provide buyers with read-only access to a list of approved suppliers in the database. 

Don t constrain yourself to purchase only from approved suppliers unless your customer demands otherwise - compensate for poor performers through subcontractor/supplier controls. 

The standard requires maintenance of equipment to ensure continuing process capability in clause 4.9.1(g) and in clause 4.9.3 requires the supplier to maintain or exceed process capability or performance as approved via customer part approval process. 

For those suppliers not conforming to Ford, General Motors, and Daimler Ghrylser requirements, other analytical methods and acceptance criteria may be used if approved by the customer. If you lack any documented methods, the MSA Reference Manual is recommended. 

The standard requires the supplier to identify inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status. 

Costs As you work at controlling costs against the approved project budget, you will often encounter conflict with suppliers who feel a need to increase costs over their original commitment. 

To assist manufactures and suppliers attain the required level of health and safety, the Health and Safety Commission have commenced approving standards laid down by such bodies as the British Standards Institution. 

In the case of Equal Opportunities, avoidance of regulatory fines and access to government approved supplier lists. 

The supermarket needs to offer organic meat at the same level every day of the year. Hunt (1989) mentioned that, as a supermarket buyer, he had been approached by several suppliers offering one tomorrow, one in two months time and two for Christmas . Safeway required ten cattle per week. To fit into Safeway s distribution system, these cattle would need to be processed through one abattoir, which should be Safeway and Soil Association approved. He believed it to be unlikely that one farmer could supply this number every week of the year. However, the example of Chisel Farm (see Chapter 10) has demonstrated otherwise. Hunt suggested that producer groups be set up in conjunction with a central slaughter point. This, however, would create the additional problem that the producers and the abattoir would have to be located so as to ensure that the transport of livestock... 

Upon identification of a new source for API, or in the event that the current API supplier makes any significant change to the approved synthetic process, revalidation should be considered. At a minimum, specificity of the method should be re-evaluated to ensure that any new process impurities and/or synthetic intermediates, precursors, etc. do not interfere with the analyte of interest. Revalidation is complete if the specificity study demonstrates that the change to the API has no adverse affect on the performance of the method. If the method is affected and changes are required, revalidation should proceed according to an original plan. 

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