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Good Business Sense

The failure to validate to a regulator s satisfaction can have significant financial implications. Noncompliance incidents can lead to the withdrawal or delayed issue of a license to pharmaceutical manufacturers to distribute their product on the intended market. The U.S. Pharmaceutical and Research [Pg.470]

The challenge is to conduct cost-effectively sufficient validation to ensure GxP compliance, and there is always debate over how much is sufficient to fulfill the regulator s expectations. Chapters 2, 4 and 13 described the basic management requirements for projects and support. Excessive validation may increase confidence in regulatory compliance, but it is expensive. Inadequate validation may be cheaper, but, in the long term, the cost of regrrlatory noncompliance could be devastating. [Pg.471]


Discuss the implications of the argument that behaving ethically makes good business sense. Relate this argument to the behavior of companies today. [Pg.17]

Some systems such as financial management systems will have no impact on GxP unless they contain special functionality that can affect GxP data. Examples would be the use of a zero price to indicate that a product should not be supplied to a particular market/customer. Another example would be financial material reconciliation affecting batch materials usage data. Even if a computer system is not deemed wholly non-GxP, it does not imply that general quality assurance principles are no longer applicable. Good business sense dictates that a quality management approach should always be applied such as TicklT, IEEE, SWEBOK. [Pg.155]

Review and Document Concerns Do not hide or ignore issues. Quality and validation after all are really about good business sense if there is a problem, hx it in the most appropriate way. [Pg.342]

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. [Pg.443]

The No Impact systems fall ont into a classification where it makes good business sense to apply Good Engineering Practices. The Direct Impact and Indirect Impact systems enter a preparation phase where the component lists of the systems are prepared for the second step of the process if the validation option is chosen. [Pg.684]

Getting to a validated state requires signihcant expenditure of time and money. As well as being required for regulatory compliance, it makes good business sense to retain the system under control. A formal set of procedures and systems are required. These should include ... [Pg.777]

Make good business sense from a process safety, quality, and environmental point of view... [Pg.10]

Defining environmental actions that make good business sense is not easy. A recent report from Earthscan sets out a number of potential green corporate benefits ... [Pg.72]

A process which is in a state of control contributes to productivity and profitability by reducing waste increasing the yield of saleable product and reducing the cost of inspection and test activities. Moreover, appropriate validation studies will facilitate pre-registration audits and expedite product registration. Validation therefore makes good business sense. [Pg.615]

This all makes good business sense and should eliminate the need for corrective work because the original validation was deficient. Both pharmaceutical manufacturers and their suppliers should know what is required, and where points of clarification with GxP regulatory authorities are required. An established industry approach may also provide the basis for the international acceptance of validation work by various GxP regulatory authorities. The acceptance by GxP regulatory authorities of each other s inspection findings, however, is not expected in the near future. [Pg.468]

As women are becoming a large percentage of toda/s labor pool, it makes good business sense to pursue them as potential drivers. How do you attract these driver candidates ... [Pg.998]

A clean and healthy working environment is good business sense reducing likely illnesses (and corresponding absences) to a minimum and providing an atmosphere that encourages the workpeople to give of their best. [Pg.255]

Like any other business initiative or change, someone must convince top management to support the initiative or change. The proposals must make good business sense, increase the profits of an organization, or provide other benefits. [Pg.515]

Why does it make good business sense to have a good safety program List four reasons. [Pg.18]

Prevention of occupationally related accidents/incidents is the law. The Occupational Safety and Health Act of 1970 (OSHAct) requires employers to provide a workplace free from hazards that could cause serious harm or death. Beyond that, it makes good business sense to prevent accident/incidents. More and more companies have come to realize that the OSHAct is a helpmate, not a hindrance, to their acddent/incident prevention initiative. The Occupational Safety and Health Administration (OSH A) sets the foundation and assumes the role of law enforcer, allowing the employer to not be viewed as the bad guy to his or her employees. Employers can deflect responsibility to OSH A. [Pg.5]

The benefits of tracking a company s workplace safety and health accidents/ incidents provides the data to assess the effectiveness of any accident prevention initiative and allows the company to determine the cost benefits of the safety and health dollars that are being spent by the company. Thus, recordkeeping and tracking makes good business sense. [Pg.287]

World Business Council for The corporate sustainability (2000) Corporate social responsibility making good business sense. World Business Couneil for The corporate sustainability ,... [Pg.299]

It makes good business sense to reduce the costs and risks associated with incidents, no matter whether they cause injuries. To do this, you must set a goal to provide a service or produce a quality product efficiently without incidents. Too often, that is seen as something to be considered as time permits, over and above regular business activities. To reduce risks effectively, you must address safety just as you would production, quality control, and/or costs [10]. [Pg.13]

The success of any business depends on the employees. That is the bottom line. As we have discussed, protecting employees from hazards not only makes good business sense, but also is the right thing to do. As part of management, you do not have to face this task alone. In this chapter, we will outline how employee participation can strengthen your management system [7]. [Pg.116]


See other pages where Good Business Sense is mentioned: [Pg.386]    [Pg.316]    [Pg.131]    [Pg.409]    [Pg.346]    [Pg.103]    [Pg.438]    [Pg.133]    [Pg.3]    [Pg.16]    [Pg.17]    [Pg.257]    [Pg.683]    [Pg.321]    [Pg.387]    [Pg.388]    [Pg.354]    [Pg.470]    [Pg.471]    [Pg.4]    [Pg.27]    [Pg.2]    [Pg.146]    [Pg.1027]    [Pg.339]    [Pg.279]    [Pg.503]    [Pg.146]   


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