员工管理培训和GMP认证外文翻译.docVIP

外文翻译 原文 Managing staff training and GMP compliance Material Source: Managing training and compliance Author: Monika Brunn Hoffman La Roche A case study is presented that describes how a software control system can ease the complex task of managing training needs across an international company, and improve GMP compliance by ensuring that employees are aptly qualified to perform their assigned tasks. What are the three most important reasons for GMP deviations? A lack of GMP training, a lack of GMP training and a lack of GMP training! The root cause for GMP deviations most frequently listed in inspection reports is the personnel involved in API manufacture and quality assurance. GMP training for manufacturing personnel is essential, as defined in Chapter 2 Paragraph 2.9 of the EU GMP Guide and in 211.25 of the FDA c GMP Guide; however, GMP control is not always as good as it should be? as demonstrated by the increasing number of warning letters, import stops and other provisions by regulatory authorities in past years. Well-qualified employees are an essential part of GMP, and training concepts and the compliance status of personnel are always within the scope of inspections. As such, requirements for qualifications, training and development of all employees involved in Gx P relevant operations must be met to ensure that employees can aptly perform their assigned tasks according to their position. The best way to accomplish this is through training programmes tailored to each employees job. This should not just end with an induction programme, but continue with annual training plans and periodic retraining to ensure that an employees knowledge and behaviour is maintained at the required level. Training should be planned, scheduled, conducted and documented using a very systematic approach, particularly in large companies. In 2006, a publication by Schaffer/Schmidt described how a pharmaceutical company established key performance ind