Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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30 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Inspections may take several forms, including desktop, virtual, and hybrid." • "Desktop inspection: A type of remote inspec- tion in which documentation (e.g., filing com- mitments, site description, and key proce- dures) is requested by the inspecting body that is not physically present at the site(s). Requests and responses to questions are shared in writ- ten form (e.g., via email or on a document- sharing platform). There can be several itera- tions of the request and review of documentation, questions, and answers. Phone calls or videoconferences take place only rarely to provide clarification about the documents requested or provided." • "Virtual inspection: In addition to sharing documentation as in any other remote inspec- tion, virtual inspections utilize technologies such as live or real-time streaming video tech- nology, screen sharing, or other means of real- time communication. Virtual inspections may include virtual tours of aspects of the in- spected site. These inspections may also be re- ferred to as distant assessments or remote in- teractive evaluations." • "Hybrid inspection: An inspection that is con- ducted remotely in part and also includes an in-person presence and on-site visit by the in- specting body. The remote and on-site aspects may be concurrent or at different times (e.g., a portion of the inspection is performed virtu- ally or desktop, followed by a second portion on-site). The combination of remote and on- site components may be captured in a single inspection report or in separate reports." Though the inspectorates have performed many remote inspections (e.g., by March 2021, the United Kingdom's Medicines and Healthcare products Regu- latory Agency [MHRA] had conducted more than 750 remote inspections [3]), little has been reported about industry experience and lessons learned. This article presents some cases to help fill this gap. Select agency experience In the United States, FDA first suspended travel for inspections except for those deemed mission critical and began requesting records to assess company com- pliance. The agency issued several warning letters to companies based solely on the review of the requested records (4). Industry was not happy that FDA was making decisions without any opportunity for com- panies to explain or defend their practices. FDA pub- lished guidance and implemented a new form, Form FDA 4003, FDA Inspection Records Request, to guide industry on what to expect (5, 6). As beneficial as the availability of this guidance is, it still leaves many questions as to how this plays out in practice. The following are therefore some examples that provide some helpful insights. Case number one. The management of an oral solids plant in Asia, holding several abbreviated new drug application (ANDA) and new drug application (NDA) licenses, had first-hand experience with this new FDA approach. This facility received a Form FDA 4003 re- questing an extensive number of records that would normally also be reviewed in a routine surveillance inspection. The company, located outside of the US, needed to translate the requested documents. The Form FDA 4003 asked for the names and qualifica- tions of the person(s) performing the translation. The company specifically asked FDA whether this request was in lieu of, or in addition to, an on-site inspection. FDA never answered this question and never made any additional requests of information to the company.

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