Competent personnel

Equipment, if necessary, should be disassembled in a suitably equipped facility and inspected for excessive wear, cracks, flaws, or deformation. Corrections should be made in accordance with the recommendations of the manufacturer. Before inspection, all foreign material, such as dirt, paint, grease, oil, scale, etc., should be removed from the inspected areas by a suitable method. The equipment should be disassembled as much as necessary to permit inspection of all load bearing parts, and the inspection should be made by trained, competent personnel. 

Competent personnel in conjunction with the manufacturer s maintenance instructions improve safe operation of all plant by means of regular maintenance. Re-commissioning in a safe manner should always follow this. It is particularly important that valves such as safety shut-off valves, non-return valves, etc. are regularly checked for soundness. 

The following should be verified by competent personnel at least annually using available documentation ... 

III.b.1.12. Sufficient government expenditure to ensure availability of medicines and staff Lack of essential medicines leads to the use of non-essential medicines, and lack of appropriately trained personnel leads to irrational prescribing by untrained personnel. Furthermore, without sufficient competent personnel and finances, it is impossible to carry out any of the core components of a national programme to promote rational use of medicines. Poor clinical outcome, needless suffering and economic waste are sufficient reasons for large government investment. 

The mutual recognition of international standards can be achieved by agreements between National Metrology Institutes (NMI). Calibration as an important activity in establishing traceability should be done by competent personnel. Therefore the competence should be assessed by a third party. Consequently agreements are also needed for accreditation bodies. 

Pharmaceutical and healthcare companies should have adequate numbers of competent personnel to implement the GAMP guidance and the standards so implied. Individuals should not be intimidated by their responsibilities but, on the other hand, the principles of validation should not be compromised either. GxP regulatory authorities will not accept staff shortages or deficient training as excuses for noncompliant validation. 

Presentation of an ISO 9000-accredited quality system, adherence to established company and industry practices, and use of competent personnel. 

If snch an approach is to be taken, the snpplier s installation work mnst be formally reviewed and approved by competent personnel, and the pharmacentical mannfactnrer mnst also ensure that the completed integration testing docnmentation is of a qnality snitable to snpport validation. The snpplier s work shonld be witnessed, or at least the resnlts reviewed by the pharmaceutical manufacturer, and a snmmary report prodnced. 

There should be an adequate number of competent personnel involved in all stages of the distribution of pharmaceutical products in order to ensure that the quality of the product is maintained. 

The designation of competent personnel to take charge of health and safety activities, or the use of competent outside services ... 

The contract accepter must have adequate premises, equipment, knowledge, and experience and competent personnel to carry out satisfactorily the work ordered by the contract giver. Contract manufacture may be undertaken only by a manufacturer who holds a manufacturing authorization. 

The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to... 

Basic information and modifications therein may be entered into the computer only by competent personnel according to a specified procedure. 

There should be a comprehensively designed and correctly implemented quality management system which is fully documented, effectively controlled and adequately staffed with competent personnel, suitable and sufficient premises, equipment and facilities, so as to provide the assurance that products have the necessary quality, safety, efficacy and therapeutic availability, comply with the requirements of the regulatory authorities and are fit for their intended use. 

All changes to a system should be approved by the quality control unit in advance and performed by authorized and competent personnel. Records should be kept of all changes including modifications and enhancements to the hardware, software, and any other critical components of the system to demonstrate that the modified system is maintained in a validated state. 

An effective goal-based approach to risk management requires the application of judgement made by competent personnel taking into consideration the available evidence. But wherever human judgement is called for it leaves us susceptible to outside influences. Bias, in the context of CRM, is the tendency of an individual to make decisions based on factors other than objective evidence. 

Ensuring working within operational limits with competent personnel and correct operating procednres... 

Member 1 Series of major process safety incidents, environmental releases, and plant shutdowns in petrochemical plant 1 Early retirement of competent personnel, major investment project, neglected maintenance... 

Uncontrolled chemical reactions are not the only sources of hazard in a process plant. This chapter briefly considers the risks of fire and explosion, and toxicological hazards. All types of hazard should be fully assessed by competent personnel using specialist advice where necessary. (See also case histories Al 70-78, pages 186-188.)... 

All planned/new facility, process, material, or equipment fully reviewed by competent personnel. 

Competent personnel together with robust operating and monitoring procedures can ensure safe, efficient, and reliable operation. It is the responsibility of commissioning personnel to ensure that these requirements ate in place and functional in time for startup. It is true that some refinement of operating instructions likely will result from the experience gained in startup and initial operation. 

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