Supplier Identification and Evaluation

ISO 9000 in an international standard for quality management systems. The standards are not specific for any particular industry, but have been adopted and are used at least by some pharmaceutical companies. ISO exists as a series of standards that covers design and development, production, installation and servicing, and inspection. ISO requires that material identification and traceability be maintained, that suppliers are evaluated on a regular basis, and that training programs are established and documented. 

The presented tools enable suppliers and producers to predict, monitor and evaluate time development of warranty costs and related indicators. These tools also enable ftie identification of potential problems in the area of warranty costs and they allow the taking of appropriate measures to reduce or prevent potential losses in time. 

Supplier selection and purchasing. This deals with procurement of materials and services that are needed from suppliers to satisfy customer demand. The problem includes such issues as identification of materials and services needed, supplier relationships (i.e., supplier selection, contract negotiation, supplier evaluation) and execution of procurement operations. 

DPSOP-338-208-1 (Reference 35) provides requirements for the identification and control of procured items. The process for the procurement and validation of vendor and contractor services is provided by the procedures that outline the procurement process and is verified by a process provided in DPSOL 338-207-3, "Supplier Evaluation Program" (Reference 36). The requirements for the proper storage of materials is initiated by DPSOL 338-204-1, which specifics storage requirements for procurement purposes. DPSOL 338-208-1 addresses the applicable identification and class storage requirements to implement the procurement specifications. The DPSOLs and RD 3.1 implement the basic requirements of QA Manual, IQ, related to procurement for safety-related applications. 

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. 

The data collected is then used to prioritize waste streams and operations for assessment. Each waste stream is assigned a priority based on corporate pollution-prevention goals and objectives. Once waste origins are identified and ranked, potential methods to reduce the waste stream are evaluated. The identification of alternatives is generally based on discussions with the facility staff review of technical literature and contacts with suppliers, trade organizations, and regulatory agencies. 

Most of the above methods of column chromatography have been, or can be, automated. Devices are available for the automated application of samples to columns which are useful for analytical evaluation of samples, or for repeated analysis or separations to obtain larger amounts of material. The specific fractions of the effluent can be collected. Equipment for these purposes can be obtained from several of the supplier listed at the end of the HPLC section above with the corresponding websites. GC systems coupled with mass spectrometers (GC-MS) and HPLC systems coupled to mass spectrometers (LC-MS) are extremely important methods for the separation and identification of substances. These are invariably linked to a computer with internal libraries which can identify the peaks, and the libraries can be continually updated (see above). With more elaborate equipment LC-MS-MS where the peaks from the first spectrometer are further analysed by a second mass spectrometer provide a wealth of information. If not for the costs involved in GC-MS, GC-MS-MS, LC-MS and LC-MS-MS equipment, these systems would be more commonly found in analytical and research laboratories. [For further reading see Bibliography.]... 

Purity profiles—Within the specification parameters, prominence is often given to the establishment of purity profiles for the key intermediates and finished goods. The FDA mandates the identification of all impurities with a concentration greater than 0.1% and generation of safety and other critical information for impurities at levels of 0.5% or higher (5). The establishment of purity profiles for the final BPCs provides for confirmation of the safety of the active material. It is often beneficial to establish purity profiles for intermediates earlier in the synthesis to prevent the carryover of impurities to the finished BPC. The maintenance of the purity profile mandates that a careful evaluation of process changes and potential alternate suppliers of solvents, raw materials. 

Step 2 . Find the hazard information about the chemical you will be using. Depending on the format used by the supplier, you may have to look in different sections, but it is usually found early in one or more sections. Look for sections that may be called Hazard Identification, Physical and Chemical Characteristics, Fire and Explosion Hazard Data, Reactivity and Stability Data, or Health Hazard Data. You may find additional information in later sections of the MSDS that can also help you evaluate the hazard of this chemical. 

The purpose of this guideline is to establish general principles for risk assessment and to enable identification of hazards, risk estimation and risk evaluation in a consistent and practical manner. The document provides a framework for carrying out risk assessments on equipment in the semiconductor and similar industries and is intended for use by supplier and purchaser as a reference for EHS considerations. 

The result of the evaluation of DAIN concerning catalogues from chemical suppliers is positive. The Fisher Chemical catalogue and the SIGMA catalogue are significant examples. As already mentioned above, these databases comprise not only information on identification parameters and use... 

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