The AIFA Manufacturing Sites Authorization Office published a communication for all pharmaceutical and active substance manufacturing sites regarding the submission of documents in electronic format.
From September 5th, the Manufacturing Sites Authorization Office will accept and request the submission of documents in electronic format, according to the provisions of article 42 of Legislative Decree March 7th 2005, no. 82, updated by Legislative Decree April 4th 2006 no. 159 and Legislative Decree December 30th 2010 no. 235, for the gradual elimination of paper records and their replacement with electronic documentation.
The documents affected by the new pilot electronic submission are the following: Site Master Files and their relevant attachments, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the application for the activation and extension of the authorization to pharmaceutical and active substance manufacturing for the market and for clinical trials, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the resolution to deviations detected during inspections , excluding a summary outline of the corrective measures adopted and any planimetry.
Any excluded document will have to be submitted in paper format.
Manufacturing sites will have to submit the electronic application also in paper format, according to the methods in force, which should include a list of the document contained in the electronic device. The electronic device will have to be identifiable both for the content and document version.
Holders of authorizations for the manufacturing of pharmacological active substances, medicinal products, medicinal gases, holders of GMP authorizations and/or certificates issued by AIFA, can send the a.m. documentation on electronic CD, in non modifiable format (.pdf; any picture or image will have to be in .jpeg, .jpg, .gif), replacing the documentation traditionally submitted in paper version.
