Executive Branch publishes guide for Technology Transfer of Pharmaceutical Production Processes
8 septiembre 2021

CHILE

On September 6, the Institute of Public Health (ISP in Spanish) published the Guide for the Technological Transfer of Pharmaceutical Production Processes, which controls the transfer of any process (together with its documentation and professional expertise) between development and manufacturing or between production sites. These provisions are already in force and here you can access the resolution of the health authority.

 Among the highlights of the document are the following:

  • It provides for a structure with eight levels of validation of production processes, between the base of critical support systems and statistics obtained inter-batch.
  • For the execution of a risk management process, it contemplates using as a reference the ICH Q9 Guide or Annex 2 of the World Health Organization (WHO) on the subject.
  • It contemplates guidelines to carry out an adequate technology transfer during the pharmaceutical production process, as well as the definition of the requirements and background information required to accredit it.
  • It indicates that this procedure is composed of several stages that include a preliminary evaluation, the preparation of the laboratory of origin, the development of a protocol that contemplates the technical aspects, the methods of analysis and the acceptance criteria, among others.

In addition, the regulation determines that a process is considered successfully transferred when it is routinely produced in the same way in the receiving unit as in the unit of origin, for which the former must review the information provided by comparing it with its own inventory for the purpose of evaluating the facilities and equipment.

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