Issue link: https://www.e-digitaleditions.com/i/1462155
Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 31 FDA confirmed receipt of the records in November 2020. The company was left wondering if this desktop audit would serve as their inspection, or whether the agency would still schedule an on-site inspection once travel restrictions began to lift. The company asked FDA about their status. In June 2021, FDA replied that an Assessment Issue Letter (AIL) will not be sent, and the document review has been completed. The agency stated it would contact the company when it planned to begin on-site inspections again. Case number two. The management of an asep- tic manufacturing facility in Western Europe was subject to a remote inspection by the Federal Drug Control Service of the Russian Federation (FSKN). The Russian regulatory authorities' remote inspec- tion approach consisted of a records request, a video tour, and daily video conferences with subject mat- ter experts (SMEs). What the company experienced was a very thorough inspection as each evening the regulatory authorities would review all the records with an unknown number of auditors and then at- tend the video conferences with well-prepared ques- tions. The inspection resulted in a few observations equivalent to what US FDA inspectors would clas- sify as Voluntary Action Indicated (VAI). Russian inspectors typically perform a two-day document review in the company's Moscow office before the remote inspection. During the virtual tour of the facility, the inspectors asked the person with the camera to go outside and access Google maps for the position so that they could confirm the location before commencing the mobile video tour under di- rection of the inspectors, following a map of the facil- ity. The company utilized Microsoft TEAMS to host the remote audit. The audit took five days, three of which included the video conferences for less than four hours each day. The remaining two days included email discussions. The videoconference audit was conducted during company business hours acceptable to the regulatory auditors. An agenda was provided, and the company paid for translators to participate in the videoconferences and translate the requested documents into English. Case number three. The management of an aseptic manufacturing facility in Asia submitted a biological license application (BLA) to FDA for a combination product with the drug substance (DS) manufactured on site, but the drug product produced by a contract manufacturing organization (CMO). The company received a Form FDA 4003, Inspection Records Request. The company asked if this would serve in lieu of, or in addition to, an on-site inspection and needed to translate the documents. The Form FDA 4003 records request included a request to confirm the specific roles and responsibilities of the various companies involved in this application and focused on the DS production at the applicant site. After a few weeks, the company received a sec- ond Form FDA 4003 requesting additional, focused documents relating to the new product application. The second request asked for complete translations of some documents that had only been summarized in the first request. In between the two records re- quests, FDA issued guidance on how it intended to continue inspecting during the pandemic. The Industry was not happy that FDA was making decisions without any opportunity for companies to explain or defend their practices.