Outsourcing contract

Doing it more cheaply (outsourcing contracts can face cost escalation, or painful and expensive break clauses when the real scope of work is discovered)... 

Projecting market demand for specific classes of therapeutics in development will remain a major planning issue for bio-pharmaceutical companies. The ability to meet the demand for biopharmaceutical production capacity, whether through in-house manufacturing or outsourced contract manufacturing, carries strategic and financial implications. Also, FDA approval policy and the development of the biogenerics market will have a major impact on future capacity requirements (see Part VII, Chapter 4). 

BPO Business Process Outsourcing. Contracting out for support services beyond information technology. Examples include human resources, finance and accounting, and logistics services. 

The next demand signal is sent to the manufacturer or converter to establish what needs to be pulled into the system to keep the flow balanced. These manufacturers can respond with shipments to one of the DCs or directly to the stores and, in the case of cyber orders, directly to a home or business location. From these manufacturers, the next signal is sent to one or more of the suppliers — raw materials, subassemblies, outsourced contract manufacturers, and possibly energy providers. From there, the signal proceeds to the suppliers suppliers of such commodities as grain, ore, minerals, and dairy products. Inbound... 

Toller An outsourced manufacturing company contracted to process materials to another company s specifications. Sometimes called third party service provider, toll processor, supplier of outside services, external contract manufacturer, contract processor, contract manufacturer, custom chemical manufacturer. 

This development has for some time involved many aspects of the boiler water treatment market but has recently extended further into the overall utilities sector. There are perhaps three levels of extended services now available the water treatment full-service program, the provision of contract labor to run a company s boiler plant, and the outsourcing of utility components or the entire facilities. 

The latest outsourcing development is for giant services companies to bundle their services together to provide a one-stop shop. A services contractor may provide some form of permanently installed utilities plant under a build, own, operate, maintain program (BOOM), so that the customer merely pays a contract fee to receive water, steam, electricity, and other services. Thus, the entire responsibility for the provision of utilities can be passed to a contractor, and not merely at one facility, but globally ... 

This applies to contract personnel as well as employees. How to communicate chemical reactivity hazards is not a trivial matter, especially when contractors are involved. Confidentiality agreements may need to be put into place, and issues may need to be addressed on a case by case basis. Communication with contract personnel and broader outsourced manufacturing issues are addressed by Early (1996) and CCPS (2000). 

ICH Q10 (2007) stated that the responsibilities of quality systems extend to the oversight and review of outsourced activities, stating that the contract giver should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required . 

And further, that the responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement . Similarly, ISO 9001 (2000) states that, Where an organization chooses to outsource any process that affects product conformity, the organisation shall ensure control over such outsourced processes. Control of such outsourced processes shall be identified within the quality management system. ... 

Snee, R. D. Lean six sigma and outsourcing - don t outsource a process you don t understand. Contract Pharma, 8(8), October 2006, 4-10. http //www.contractpharma.com/ issues/2006-10/view features/lean-six-sigma-and-outsourcing/. Accessed on 04th September 2012. 

In 1975, the first commercial entity was formed to provide multicenter, outpatient clinical trial contracting services in the United States. This was the beginning of the modern Contract Research Organization (CRO) industry. It is now composed of thousands of domesfic and infernafional firms involved in medical producf evaluations in humans. The total annual expense globally for clinical trials and related functions necessary for commercial, governmenf, and academic therapeutic product development is estimated at US 50 billion, of which about US 15 billion is outsourced to the contract services market. 

Contract research organisations are likely to be more efficient, and on occasion can be faster than the company. A balance has to be struck between the outsourcing costs, internal costs (which are often underestimated) and the management requirements and skill sets of the CRO and internal staff. 

In-house maintenance services at the toller site become an outsourced function. The client company must determine if their toll will be impacted. If so, work with the toller to evaluate the compatibility of the new contract maintenance personnel. 

A dimension of the increasing disintegration of pharmaceutical R D is the growing use of contract research organizations (CROs) to conduct clinical trials of new drugs. By 1999, 23% of trials were outsourced to CROs (Azoulay 2004, pp. 1593,1600). In general, the more data-intensive projects are outsourced, while knowledge-intensive projects are more frequently undertaken within pharmaceutical companies (p. 1592). 

---