By means of Exempt Resolution No. 1746, dated September 6, 2021, the Institute of Public Health (ISP) approved the Guide for the Technological Transfer of Pharmaceutical Production Processes (hereinafter “the Guide”), prepared by the National Drug Agency Department.
The purpose of the Guide is to provide guidelines to carry out an adequate technological transfer of a pharmaceutical production process, and to specify the requirements and background information needed to accredit it.
For WHO, this transfer is a logical procedure that controls the transfer of any process along with its documentation and professional expertise between development and manufacturing or between manufacturing sites. This can occur at any stage of the life cycle of the process, and is caused by the change of site or location from where it was originally implemented to some alternative site.
Thus, the Guide:
1. applies to (i) pharmaceutical products that require accreditation of the transfer from a pilot plant to an industrial scale manufacturing plant and, (ii) to pharmaceutical products for which accreditation of the transfer of the production process to a new plant is required, either by a change or inclusion of a new manufacturing site.
2. It establishes that the process is made up of different sequential stages that include (i) a preliminary evaluation and (ii) a preparation of a protocol by the issuing or originating pharmaceutical laboratory to develop and approve the technology transfer process, which establishes the technical aspects, tests, analysis methods and acceptance criteria, and considers the appropriate statistical tools to analyze the results.
3. Provides that once the productive process has been transferred and validated, the results shall be documented in a technology transfer report, prepared by the originating unit and the receiving unit, in order to constitute documented evidence that the process was successfully carried out.
|Should you require additional information on this matter, please contact Andrea Abascal (email@example.com), and/or Rocío Vergara (firstname.lastname@example.org).|