Internal company policies

Adherence to internal company policies, SOPs, protocols Stability Protocol Scientific basis... 

The following is a listing of the typical distribution of reports. Internal company policies may require additional copies of reports for senior management review. 

In addition to typical functions required by the application, other functions required by regulations and internal company policies should be tested. These include ... 

Disciplinary policy Safety and health professionals should be well-versed in the internal company policy regarding negative reinforcement, especially disciplinary action for violation of safety and health requirements. Company disciplinary policies usually consist of various versions of verbal warnings, written or formal warnings, suspension from work without pay, and involuntary termination. 

Please provide information concerning any other accidents involving the applicant that were reported to government agencies or insurers or retained under internal company policies ... 

Internal company requirements should be considered in designing your PSM system. In some companies, the internal policies applicable to U.S. plants do not yet apply in all other parts of the world. Most companies are moving toward uniform worldwide internal standards, but some are still phasing in the more ambitious internal standards in places that started out with weaker programs. Your PSM design should not assume the implementation of internal standards that have not yet been introduced. 

One member of your staff suggests that if your department spends just 10,000 to improve a process, it will yield cost savings of 3000, 5000, and 4000 over the next 3 years, respectively, for a total of 12,000. Your company policy is to have an internal rate of return of at least 15% on process improvements. What is the NPV of this proposed improvement ... 

The vendor qualification policy will ensure that vendor qualification activities are performed under the auspices of quality assurance. Additionally, a thorough review of the vendor qualification ownership will be performed, and additional resources will be assigned, if needed. An expanded training program will be developed and implemented to ensure that all staff associated with the vendor qualification program are trained on the new and improved policy and procedures. Verification and monitoring of conformance with the company s vendor qualification policy and procedures will be performed periodically through internal company audits. 

Internal written policies and procedures must be developed to define the scope of QA activities within the company. These policies and procedures should encompass those areas within the company that, after an assessment of risk, provide the most assurance that safety and integrity are designed into the drug development process. 

SOP review by QA auditors is certainly recommended before issue to ensure the SOPs are consistent with applicable international, country-specific and regional regulations, ICH guidelines (not limited to ICH GCP) and company policies and procedures. 

When neither a patent assignment danse in an employment contract or in a policy statement in an internal company document exists, employer ownership of patent rights can be implied for employees who are hired to invent, i.e., those hired either for a specific project or problem or for their expertise in a specific area. If the inventor is an officer or director of a corporation or other business entity, a special obligation to assign may exist as part of the officer s or director s fiduciary duty toward the entity. 

This crossroad was reached by the U.S. chemical industry during the early 60 s. The key decision to be made was should the overseas department (or international company or overseas division) continue to have sole responsibility for ex-U.S. business, or should responsibility for worldwide business permeate the company as a whole If the latter course was to be followed, the next step was to determine how policy... 

Standard ISO/IEC 17025 2005 requires that the laboratory implements routine internal and external audits. Internal audits are managed by the quality manager appointed within the laboratory. The purpose of internal audits is to verify that the laboratory is complying with the requirements of the standard and with company policies, processes, and procedures. These audits are also useful in preparing for external audits. External auditors can come from clients or from accreditation bodies. Their purpose is to verify that the laboratory is operating in compliance with ISO/IEC 17025 2005. 

Every person involved in clinical research, be he/ she a monitor, an auditor, a statistician, a medical adviser, a medical director, a head of department, a co-investigator, a company or health service chief executive, or a university vice-chancellor, should be committed to such a policy and to its publicity, not least to act as a deterrent, in a determination to stamp out fraud in clinical research if it is humanly possible. Every international company, every regulatory authority, and every individual pharmaceutical physician should strive to ensure that there is an effective mechanism in place, in every country, by which anyone who commits fraud can be summarily dealt with. Only the utmost vigor in applying this policy will be successful, but it is in the ultimate interests of patient safety that this happens. 

In this chapter, an example company policy for quality assurance of IT (information technology) systems is presented. It provides an overview of Good IT Practices that would normally be expected from internal IT project and support groups within a pharmaceutical manufacturing company. These IT practices are equally applicable to supplier organizations providing project and support services. 

The rule requires the use of secure, time-stamped audit trails. This provision is key for the FDA during validation, tests should be run to ensure that each record is time and date stamped. The question has arisen "which time " Mr. Paul Motise has been unequivocal in stating that the time must be local time, though this will cause some confusion across time zones and may impact company policies on time recording. The case for international time stamping has been eloquently argued by Ken Chapman and Paul Winter [3] in a "white paper" they have recently made available. 

Because BP is an international company, its educational interests are global, as well as national and local. A two-day conference was held in Brussels in November of 1989 to which all BP s main European subsidiaries sent a senior executive, who in turn brought a personnel or educational specialist from within their subsidiary plus two educators from their districts. The participants were told to devise an educational policy for BP that crossed national boundaries. 

Larger companies often have a corporate group that leads hazards analyses (and that also conducts safety audits). Personnel from these groups will provide more of an outside perspective than plant people. They will also have a good knowledge of internal standards and policies. However, their knowledge of the realities of internal company issues and reporting structures may unconsciously affect their independence. 

Expenditure for compliance with company policies and for environmental reviews, auditing procedures, verification, and registration can vary according to company size. Consultation fees of 10,000-50,000 can be expected for small companies, with an addition of 10,000-20,000 for intermediate size companies. Results from the UK report costs of 15,000 for internal preparation and an additional 7000 for external verification [22]. 

All the work involving animals was carried out in accordance with European Directive 86/609/EEC governing animal welfare and protection, which is acknowledged by Italian Legislative Decree No. 116, January 27,1992, and according to internal review performed by the GlaxoSmithKline Committee on Animal Research Ethics (CARE) and to the company policy on the care and use of laboratory animals. 

Another benefit of hiring from within is that training on company policies and practices takes less, if any, time. Your internal driver candidate should be familiar with all the safety policies and practices of the company. 

An internally developed set of standards regarding company policies and requirements for safety and general conduct. 

As it is essential, that the importance of safety is understood both by the very top of the company and by all other employees, an internal safety policy, valid for every single person in the company, was written down, including a statement from the CEO about the importance of safety and his commitment to the implementation of safety ... 

Emergence-. In addition to the role of the legislator and the employer, public policy may also take on the responsibility of the client in the case of public procurement. Public procurement is often a highly regulated process with a number of preconditions and some of these are clearly CSR issues, which need to be taken into account. In fact, CSR may also often be defined in the legislation. The problems for international companies may be that there are different types of the legislation in several countries which aU need to be included in the company s CSR policy. 

Internal audit results should be posted in the division office on the safety bulletin board and on bulletin boards in the area being inspected. Results should be posted immediately upon completion, with action items noted on the form. Positive recognition should be listed first, indicating items that were noted during the review as safe and in compliance with company policy. 

Review Policy The review policy should estabhsh when project safety reviews should be done. All capital projects, large or small, should have one or more safety reviews during the course of the project. The number and types of review shoiild be stated in a management policy. Any reasons for exceptions to the policy should oe documented as well. The policy should address not only projects internal to a company, but also any joint ventures or turnkey projects by outside firms. 

Ensuring that the policy is relevant to the expectations and needs of the organization s customers is a little more difficult. Companies need to predict what their customer expectations and needs are (now a requirement in clause 4.1.4 under Business plans). They may be beyond what they specify in contracts although they may in fact be identical to such specifications. For companies to create satisfied customers they not only need to meet requirements specified by the customer but meet national and international legislation and have consideration for the needs and expectations of society. As explained in Part 1 Chapter 1 on Quality characteristics, customers are not only the buyers but comprise several other interested parties. You need to provide a means of determining what the customer expectations and needs are and then subject the written quality policy to a review against those expectations and needs to determine if there is any conflict. As part of your business planning procedure you should indicate how you determine your customer s current and future needs and expectations. 

This Committee published its own technical rules, many of which were later incorporated into British Standards. It continues to make an active contribution to standards, guidance notes, legislation and international policy on inspection. Some independent inspection bodies have no connection with insurance but many do, and these companies have the advantage of feedback from an analysis of insurance claims. 

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