Competent personnel persons

This decision is one that must be made after carefully considering all of the circumstances and, of course, based on the requirements. The reportable quantity rules may come into play. The principle behind these requirements is that the more dangerous a material might be to personnel, surroundings or the environment, the smaller the reportable quantity. A competent person should review each occurrence to help determine the appropriate action. Sometimes, even a very minute spill must be reported. If doubts occur as to the applicability of the requirements, take the safe rather than sorry stance. 

Inhalation Prompt medical attention is mandatory in all cases of overexposure. Rescue personnel should be equipped with self-contained breathing apparatus. Conscious victims should be carried (not assisted) to an uncontaminated area and inhale fresh air with supplemental oxygen. Quick removal from the contaminated area is most important. Keep the patient warm, quiet, and under competent medical observation until the danger of delayed pulmonary edema has passed (at least for 72 h). Any physical exertion during this period should be discouraged as it may increase the severity of the pulmonary edema or chemical pneumonitis. Bed rest is indicated. Unconscious persons should be moved to an uncontaminated area, and if breathing has stopped, administer artificial resuscitation and supplemental oxygen. Once respiration has been restored they should be treated as above. 

Recruitment and placement of pharmacy personnel are two of the most important tasks a manager can undertake. If a manager finds and hires competent, self-motivated professionals, issues such as motivation and performance are less of a problem. Good hiring practices also diminish employee dissatisfaction and turnover by matching the right person with the right job. 

In order to establish and maintain a pharmacovigilance system, the holder of the marketing authorization is required to have permanently and continuously at his or her disposal an appropriately qualified person. This qualified person is personally responsible for ensuring that information about all adverse reactions that are reported to the personnel of the company and to medical representatives is collected and collated. This qualified person is also responsible for ensuring that all suspected serious adverse reactions are reported to the competent authority concerned. 

Ensure a Competent Public and Personal Health Care Workforce. This service includes education and training for personnel to meet the needs for public and personal health services efficient processes for licensure... 

High standards of personal hygiene and cleanliness are essential. Personnel involved in the manufacture of sterile preparations should be instructed to report any condition which may cause the shedding of abnormal numbers or types of contaminants periodic health checks for such conditions are desirable. Actions to be taken about personnel who could be introducing undue microbiological hazard should be decided by a designated competent person. 

Personnel should practice good sanitation and health habits. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of excipients should be excluded from direct contact with components, excipient containers and closures, in-process materials, and finished excipients until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of the excipients. All personnel should be instructed to report to supervisory personnel any health conditions that may have an adverse effect on excipients. 

The manufacturing and control operations shall be performed under the supervision of qualified and competent persons as specified in Section 3 (Personnel). 

Personnel involved in the manufacture of sterile products must be instructed to report signs of a skin disease or an illness which could have an unfavorable influence on the quality of the product to their boss. A competent person, if necessary after consulting with an expert, will decide what measures are to be taken. The personnel involved must have periodic followup medical examinations. 

Only persons whose health can not have a negative influence on the quality of the manufactured drugs can be employed in production. The personnel shall report any skin condition or contagious disease. In well-founded cases, the competent authority may require the personnel assigned to production to have medical examinations — periodic if necessary. 

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