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13 September 2013

GMP Training Procedure

A fundamental aspect of the GMP regulations (Good Manufacturing Practices) is personnel qualification which is grounded on the combination of three characteristics: education curriculum, working experience and training.

The personnel contribution is fundamental in order to obtain products with quality, safety and efficiency features fit for the targeted purpose; therefore, the aim of training is to enable every employee to correctly perform one’s own tasks, thus ensuring a significant contribution to the quality of the products.

But with a complex Quality System and a relevant number of people to train it is difficult for a company to manage training and to make sure that every single employee is trained in every necessary topic to correctly perform one’s own tasks. Sometimes, in fact, the companies training plans are not fit for the purpose of training management.

GMP state that the attendance and training in the Good Manufacturing Practices themselves must be managed so as to guarantee that personnel operating in critical GMP areas stay well-acquainted with GMP concepts. Although a specific attendance is not set, Regulatory Authorities generally expect a yearly attendance.

 

Our consulting services

  • Helping companies to implement an employee training management system which ensures complete control over the training of every employee operating in critical GMP areas
  • Innovative GMP courses which allow to maintain annual attendance, fulfilling the Authorities’ expectations

 

GMP training courses, based on a traditional prospectus, are often ineffective and the operators continuously fall back into mistakes which lay the product quality on the line and, consequently, the patient’s health. Our courses are not of that kind.

 

Use cases

  • To renovate one’s own training management system
  • For new employees
  • For employees operating in critical GMP areas, periodically scheduled
  • To ensure that every employee is trained about procedures/processes/methods pertaining to his/her task, thus fulfilling GMP requirements about training and sparing the company remarks from Regulatory Authorities
  • For a continuous upgrading and training of co-workers or functional managers
  • When a company which produces excipients has to implement or improve its Quality System to be able to state sincerely that the produced excipient is of pharmaceutical grade
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