Approved supplier list

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

This activity includes information on contractual arrangements with suppliers and points of contact, relationship history (orders, fulfillments, disputes, resolutions), business evaluations, and technical evaluations of products and capabilities, including certifications for specific materials. For specific materials (or product families), there are approved supplier lists that identity supphers from whom the organization may order that material, often with preference ranking or ranking criteria. 

Approved Supplier List Audience Share Research Balanced Scorecard Batch Production... 

Updating yom approved supplier list and managing inventory conversion. 

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... 

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

Note Certain of these requirements may not necessarily appear on the prime specification document. There may be for example, standard company sampling procedures. List os approved suppliers and soon to which the specification explicitly or by implication, refers. 

A list of approved suppliers of starting materials should be established and reviewed as necessary. 

As we mentioned in the previous chapter, its approach used a codification system (Risk Phrases) that was based on toxicological evidence of harm arising from exposure to substances. Criteria for codification were set out in Annex VI to the Dangerous Substances Directive (67/548/EEC) as amended by its Seventh Amendment (92/32/EEC). Annex I to the Dangerous Substances Directive included risk phrases (R-phrases) for all substances with an agreed hazard classification in the EU. This information was reproduced in the UK in the Approved Classification and Labelling Guide (Third Ed.) whilst specific substances and their R-phrases were listed in the Approved Supply List. If any substance supplied to a workplace within the European Community was not listed in Annex I to the Directive, the supplier was required to consider whether a hazard classification was appropriate and if so, based on the classification criteria, apply the appropriate R-phrases as well as other information. 

In another case, I received a call from a selected supplier and was asked wlty they were being considered because they had been mistreated by a plant before and had been removed from the approved list. Someone else s product had been analyzed and they were accused of sending in the wrong material. An individual had created the problem who had no authority to remove artyone from the approved supplier hst. The team had to deal with this and work through the past history and help the compare get back on the approved list if they were selected. This was a difficirlt issue since it was in an organization that had grown by acquisition and had not been combined very well. 

Step 11. Upon receipt of all the approvals noted in this procedure, including the execution of a supply contract, the suppher is added to the list of approved suppliers for the specific raw material. 

Approved Material List (AML) A list of approved suppliers and materials. Some companies seek to expand the AML to increase options for product design and to avoid single-source or end-of-hfe componenets. 

The attribute assessment determines whether the container materials meet the specifications. A risk assessment should be performed to determine what level of quality assessment needs to be undertaken. This risk assessment should take into consideration the level of quality assessment performed by the manufacturer or supplier. For example, if the manufacturer has a limited quality assessment system, then the purchaser may be required to carry out an extensive number of checks. An audit of the manufacturer is the best way to determine what level of assessment needs to be undertaken by the purchaser. An audit may be part of certification or accreditation of the manufactiuer or the supplier. Audit findings can provide a list of so-called reliable suppliers (see also Sect. 21.5.1). The level of quality control imdertaken by a container manufactiuer can be obtained from one of these audit reports. When using an established approved supplier, a purchaser could reduce the amount of testing that needs to be undertaken. For example the level of testing could be reduced to an identity test and assessment of the supplier s certificate of conformity. A limited identity test could include dimensions, colour and text. Additional tests for parenteral product containers could include ... 

Final elements Final elements from an approved manufacturer suppliers list Acceptable 1oo1/1oo2 Acceptable 1oo1/1oo2 Acceptable 1oo2... 

The analysis certificate is the document that gives the results of the inspection made on a representative sample taken from a product before its delivery. It must contain the results of all checks in a list approved jointly by the client and the supplier. 

The approved list of suppliers for products affecting quality is maintained (refer to the purchase manual). 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

For sequencing by the chemical procedure, Maxam and Gilbert (1980) give a detailed list of approved chemicals and suppliers. 

FINAL SYSTEM VALIDATION APPROVAL The signatories below have reviewed the validation package for the [name of the supplier (vendor), and name of system] computer system. The review included the assessment of the phase reports listed below, including details of the execution of approved test scripts, test phase conclusions based on test phase acceptance criteria, and resolution of items listed in issues log. The determined validated status is derived as a culmination of this review process. ... 

Regulators consider the VMP to be the first fundamental commitment of the pharmaceutical organization to the validation process. In particular, the VMP must recognize that different approaches may be required to meet the differing capabilities of the various suppliers contributing to the EMS architecture. The VMP must be reviewed and approved by the project sponsor, GxP process owners, and quality assurance representative. Table 31.4 lists the typical contents of the VMP. 

At some point of his work, all of the vendors that he and others knew were contacted and asked for input to be used in this publication. Unfortunately, only very few provided information that fitted formats which the author had prepared so that an unbiased comparison of data and technical details, publication of which does have the supplier s approval, can be provided. Therefore, the latter idea was given up and those vendors that were or became known to the author while preparing the book are included in the following listing. Companies and individuals that have provided support beyond the normal are identified in the Acknowledgements and are referred to with gratitude in figure and table captions. 

Companies have processes for the approval of new vendors but that should be ignored at this point in the analysis. A good example of this is the production part approval process (PPAP) for the automobile industry. Other companies have different processes for getting materials on the approved lists. If a supplier is selected that is not on the list, the supplier will be required to go through the approval process and get the material on the approved list. 

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