Work Contracted Out

Pharmaceutical manufacture may involve the contracting out of certain operations in the process, such as packaging and labelling, terminal sterilisation of products. 

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Factory workers on each of the worked shifts Consider the arrangements for holidays Quantify work contracted to outside organizations Work contracted out is usually difficult to quantify. The accounts department will probably have records of the cost of such work and this can be employed to provide an indication of the significance of the work in relation to the operations within the company. 

Work contracted out - contract clearly defining responsibilities, subject to GMP inspections... 

Work contracted out - subject to contract, and under the same conditions, without subcontracting. 

Resorting to outside laboratories may be authorized in accordance with the rules on work contracted out laid down by this Executive Order. 

The contractors in turn may be bringing in subcontractors. The work contracted out can include operations such as call centres to answer inquiries, generate business or solicit donations, or a myriad of other tasks. 

Many oil and gas companies do not consider the detailed design and construction of production facilities as part of their core business. This is often the stage at which work is contracted out to engineering firms and the client company will switch manpower resources elsewhere, although some degree of project management is commonly retained. 

Biocatalysts Ltd. is an independent company that since 1980 has been devoted to the manufacture and sales enzymes. Since it is not part of a larger chemical, food ingredients or pharmaceutical company, instead of producing large volumes of commodity enzymes, it produces enzymes tailored to customer needs. Their services include working together with customers to industrialize their processes or to produce specific required enzymes. Usually, these customer sectors do not require single enzyme entities, but enzyme complexes where the ratios of each of the components are crucial to the efficacy of the whole enzyme-biocatalyst product and to the customer s process. Fermentation requirements for the manufacture of enzyme products are sub-contracted out. 

The NASA organization was highly complex and several parts of the project were contracted out to private consultants whose livelihood depended on the success of the project. Production objectives emphasized the importance of the launch date for each mission. In light of the safety concerns and potential setbacks, work continued on the project. Had the... 

There is a growing reliance by sponsors on contracting out part or all of the work of the clinical trial to a subcontractor. Manufacturers... 

Since in-house facilities for handling a large volume of samples for routine analysis were not available, the analytical work was contracted out to three commercial laboratories. We will refer to them as Laboratories A, B, and C. The contractors were selected on the basis of qualification tests which were intended to serve also for interlaboratory calibration. The results were reported to NRDL as d.p.m. or equivalent 285U thermal-neutron fissions at detonation time. All of the radiochemical data obtained from the laboratories are reported in Ref. 5. These values were punched on cards and converted by computer to equivalent fissions of the device, based on mass-chain yield values supplied by the weapons laboratories. At the same time, the calibration factors derived from qualification-test analyses were applied. Values of the ratios, 95, were formed. All of the ratios for a given nuclide i were then selected along with the corresponding values of r89t95, and the data points were fitted... 

Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. A recent industry survey reported that the vast majority (86%) of the companies responding say they outsource analytical methods development to contract laboratories. Twenty-five percent of the responding firms indicated that they often or always contract out stability testing on development compounds [37]. There are important criteria to follow in working with contract laboratories to ensure that their methods validation procedures yield results that are consistent with those of the client company [38]. This topic will be discussed later in this chapter. 

Z. Zurakowski, A Study of the Applicability of ISO/IEC 17799 and the German Baseline Protection Manual to the Needs of Safety Critical Systems, Final Report, March 2003, on work carried out for JRC ISPRA under contract N° 20215-2002-12 F1EI ISP GB., 268 pages, (www.ewics.org)... 

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. 

With pure or fundamental research the provision of commercial opportunities is, by its very nature, a long way into the future. However, in industry this is the final objective, no matter how far into the future, it is not science for the sake of science. This type of long-term work is uncommon in most chemical companies and at best only represents a very small fraction of total R D budgets, even in the largest companies. It is often contracted out or carried out in collaboration with research institutes and universities, these bodies finding that it provides them with a useful source of funding and indeed a new role in the economic welfare of a country. The time frames and measures of success are quite different from product oriented research and when carried out in industry requires special management skills. This will be dealt with in Section C on innovation and creativity. 

Another way of overcoming some of the difficulties that can arise with the SBU organisational structure is for R D to be outside the business tube, acting as a contractor to the business unit This can be described as insourcing as opposed to outsourcing In this case, R D retains its functional independence, contracting out its services to the business unit, paid for on an as needs basis. The work is carried out physically within R D laboratories on behalf of the business unit. This is illustrated in Figure B5. 

This research was funded by the U.S. Department of Energy (Contract DE-AC22-80PC30298). The Project Manager was J. Hicker-son and the Technical Monitor was J. Fischer. The authors wish to acknowledge also the experimental work carried out by Y. Kwan and useful contributions from W. R. Seeker and G. S. Samuelson in formulating the technical approach. 

The work carried out at Berkeley was supported by the Director, Office of Energy Research, Office of Basic Energy Sciences, Chemical Sciences Division of the US Department of Energy under Contract Number DE-AC-03-76F00098. Additional support was provided by... 

Received April 30, 1962. Work carried out under contract DA-01-021-ORD-11878. 

Received for review March 27, 1957. Accepted June 19, 1957. Work carried out under contract with Air Reduction Co., New York, N. Y. 

Success with outsourcing, however, has led senior executives to express such views as If I can contract out cafeteria and building maintenance, I can contract out clinical research . Characteristics of this modern view of working with a CRO are illustrated in Table 54.2. 

This review examines the work carried out either in-house or via external research contracts by Solvay Interox into the area of heterogeneously activated aqueous hydrogen peroxide chemistry. The review is focused on the preparation and use of solid catalysts in the presence of H2O2 for the manufacture of fine chemical and pharmaceutical intermediates. 

The use of market mechanisms by outsourcing placement services to external providers through placement vouchers or via subsidised temporary work (PSA) has been implemented as a complementary option to improve efficiency and effectiveness of core employment services (Konle-Seidl 2005a). The need for more individualised services for hard-to-place unemployed persons, however, opens up broader options for contracting out employment and welfare service provision. In this sense the BA started a new pilot in July 2007 to test successful context criteria for a better involvement of private agencies. The step to a further privatisation of the German PES takes the British Employment Zones as an example. 

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