Suppliers, external

Virtual screening assists the selection of compounds for screening in-house libraries and compounds from external suppliers. Two different strategies can be applied ... 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

A control sample is a sample for which the concentrations of the test analyte is known and which is treated in an identical manner to the test samples. It should ideally be of a similar overall composition to the test samples in order to show similar physical and analytical features. For instance, if serum samples are being analysed for their glucose content, the control sample should also be serum with a known concentration of glucose. A control sample will be one of many aliquots of a larger sample, stored under suitable conditions and for which the between batch mean and standard deviation of many replicates have been determined. It may be prepared within the laboratory or purchased from an external supplier. Although values are often stated for commercially available control samples, it is essential that the mean and standard deviation are determined from replicate analyses within each particular laboratory. 

External suppliers It is good for security of supply to have several external suppliers, as this means that a country will be less affected if something dramatic happens to/in a single country. 

The other driving force that has propelled the outsourcing concept to the forefront is the formation of virtual companies. The concept of the virtual corporation is based on the assumption that pharmaceutical companies can outsource almost every aspect of their operations to form a business that has very close links with its external suppliers but is nonetheless a separate entity. Taken to its logical conclusion, the pharmaceutical company could consist simply of a head office containing the core departments and the key decision makers. 

The following process is applicable for changes to any component of computer technology that performs functions on regulated products, including hardware, peripheral devices, system software and utilities, application software, documentation, and communications hardware and software. These components can be either purchased from an external supplier or developed in house by the company or its designee. 

The compound selection methods described thus far can be used to select compounds for screening from an in-house collection, or to select which compounds to purchase from an external supplier. In combinatorial library design, however, it is necessary to select subsets of reactants for actual synthesis. The two main strategies for combinatorial library design are reactant-based selection and product-based selection. In reactant-based selection, optimized subsets of reactants are selected without consideration of the products that will result and any of the compound selection methods already identified can be used. An early example of reactant-based design is that already described by Martin and colleagues which is based on experimental design and where diverse subsets of reactants were selected for the synthesis of peptoid libraries [1]. 

Contracts of supply should exist for all computer systems acquired from external suppliers. The contract should include terms and conditions to dehne individual responsibihties, the assigmnent of responsibilities to third parties, conhdentiality, intellectual property rights (IPR), and terms of payment. It is very important that infringements, liabilities, and insurance are also covered, and it is determined how these are affected by circumstances outside the control of the customer and the supplier. Contract details should be reviewed during Supplier Audits as appropriate. Contract documentation should be retained as specifically required by some regulatory requirements in support of validation. 

Questions often arise regarding the relationship of internal vs. external suppliers, especially within large pharmaceutical and healthcare organizations, and the corresponding role of Quality and Compliance. Expectations for these organizational stmctures are discussed below. 

Raise Concerns with Supplier A Suppher Audit should be considered for external suppliers, possibly positioned as free consultancy on pharmaceutical and healthcare requirements. Be realistic about corrective action planning. Prioritize where effort needs to be placed. 

Determination that personnel (including external suppliers) who develop, maintain, or use electronic record/electronic signature systems have documented education, training, and experience to perform their assigned tasks. 

Pharmaceutical companies need not be self-sufficient in aU their operations all the time, so they obtain certain goods and services from external suppliers, in a practice known as outsourcing. These goods and services do not merely represent, say, office supplies and corporate advertising remarkably, they also include scientific research. External suppliers furnish to some fipcos the results of chemical and biological drug discovery efforts as well as... 

As the molecular masses and amino acid sequences of the protein hormones increase, the cross-reactivity of antisera in the different species becomes more problematic, and homologous antisera are required (Miller and Valdes 1992 Valdes and Miller 1992). Several homologous reagents are commercially available (e.g., prolactin, thyrotrophin, luteotrophin, and follitrophin for rats, and canine thyrotrophin). Some very specialized centers are able to produce suitable antisera given purified hormones, but this is a time-consuming process and the majority of toxicology laboratories use antisera from external suppliers who often can provide information on cross-reactivity. 

Each external supplier of dangerom materials has to reveal the composition of its product, otherwise it is not even considered for the use in any VW plant. Volkswagen uses toluene in very few preparations (beside the sector for surface treatment with varnish). 

Audits are conducted as a management tool for assessing the quality level of an operation. They are used to identify nonconformance and to make corrective actions as needed, and prevent reoccurrence of potentiail problems that can adversely affect a product. Audits are conducted internally and externally. Supplier audits may be directed for cause , such as a customer complaint, for change control, or for a product problem. Audits may be scheduled on a regular basis (e.g., every 3 years) for suppliers of key or critical materials. 

Only a few compounds screened in early lead identification phases are synthesized in-house. More flexible and cost effective is to purchase chemicals from external suppliers. Most vendors provide lists of some ten to himdred thousand chemicals on compact discs and guarantee delivery within days to weeks. To explore this huge amount of data with the aid of computers, chemical information is transformed to computer-readable strings, e.g., smiles code, and different descriptors are determined. 1-dimensional (1-D) descriptors encode chemical composition and physicochemical properties, e.g., molecular weight, stoichiometry (C O Hj,), hydrophobicity, etc. 2-D descriptors reflect chemical topology, e.g., connectivity indices, degree of branching, number of aromatic bonds, etc. 3-D descriptors consider 3-D shape, volume or surface area. 

Key players that can be identified in this process are as follows all levels of management, the persons responsible for the processes and activities to be performed under GxP, suppliers (external suppliers as well as internal system developers), IT/system managers (including service providers, if applicable), system users and Quality Assurance (QA). It is highly recommended to also involve the Purchasing and/or Legal departments in the process if new modules, updates or extensions are required. Table 13.3 indicates the basic roles, responsibilities and tasks for the key players in order to validate systems and to keep them validated. Most of the responsibilities and tasks are equally relevant for the period prior to initial validation and for keeping the systems validated. 

A list and associated description of the key attributes of the platform needs to be included. Attributes should be defined to document platform components sufficiently. These elements include hardware or equipment sets being used as well as necessary software algorithms. Elements also include what incoming materials are used on the process. Incoming materials may be from internal or external suppliers. When environmental controls are necessary, such as clean-room conditions, that also should be included. Also, items related to carrying out the process, such as methods, skills, and process conditions, should be summarized. 

For integrated planning approaches, all elements in the considered chemical SC are relevant including transport relations to (external) customers and suppliers. Only external suppliers or customers themselves are not modelled in detail. 

The production of patterns and dies is generally carried out by specialised external suppliers. These activities are found in the metal and plastics treatment sectors. 

Products and their production programs were broken down into components, modules, and subsystems, and key competencies concentrated on them. In-house manufacmring was then drastically reduced, while orders for required items were shifted to external suppliers. In addition, the workforce was considerably reduced as well. 

Communication The success of TQM depends on clear communication among all the departments, seniors and juniors, and technical and non-technical personnel in the organisation and external suppliers and customers. Persons receiving the message must clearly understand the ideas the sender intended to commimicate— when they are specially related to the required product quality and delivery schedules. Only correct information shall be communicated by the sender to the receiver to maintain the trust. 

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