Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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32 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Inspections guidance says that FDA may make use of the infor- mation in inspection reports issued by other regula- tory authorities, for which mutual recognition agree- ments (MRAs) exist. Furthermore, the new Form FDA 4003 was updated to clarify if the request is an Inspection Records Request with or without an in- teractive assessment or in lieu of or in addition to an (on-site) inspection. As of the writing of this article, FDA had not informed the company if they intend to either conduct an interactive assessment or an (on- site) inspection, leaving the company in limbo. Case number four. A company in Western Europe was remotely inspected by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Over three months, the agency requested nearly 600 documents in several installments. Every document had to be translated in its entirety and annotated. The annota- tions are necessary to provide context, which would normally be provided by company staff when hand- ing the documents to inspectors on site (e.g., specific pieces of information may be difficult to find within a document and attaching pointers is sensible). PMDA insisted on email communication and would not agree to video conferences or phone calls with the site. Lessons learned Though regulators have published various guidance documents on remote inspections, much of the ac- tual details, such as structure, length, etc. remain unclear. Even though the inspectors have every in- tention to resume on-site inspections, this will not happen quickly, especially when it comes to overseas inspections. Thus, industry must be prepared for re- mote inspections for some time to come. Being pre- pared means having the procedures and processes in place to respond to documentation requests and to host virtual inspections. The COVID-19 pandemic has changed the world we live in. Regulatory authorities responded to the challenge by implementing alternative means of evaluating company compliance. Challenges for the regulated industry remain, such as: • Accurate translation of the requested documents with a short time frame for response • Not knowing if the records request will be followed by an interactive assessment or inspection • More thorough review of documents as many more documents are requested and reviewed • MRAs have not been utilized as envisaged by industry (i.e., there has not been a significant reduction in inspection requests) • Regulatory authorities do not have an inspection trip timeframe limiting them • Technical challenges of setting up the SME in- terviews using video conferencing software, conducting virtual site tours • Potential delay in approval of new products due to delayed pre-approval inspections. As noted from the case studies provided, learning from the experience of others is one of the best ways of understanding and preparing for the challenges of remote inspections. References 1. EC, Directive 2011/62/EU of The European Parliament And Of The Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal product. 2. PDA, Points to Consider in Remote and Hybrid GMP/GDP Inspections, May 2021. 3. MHRA Inspectorate blog, Inspectors Grounded–A Year of Innovation, March 26, 2021. 4. J. S. Eglovitch, "FDA's Document-based Inspections Prompt Warning Letters for GMP Violations,", April 13, 2021. 5. FDA, Staff Manual Guides, Volume IV - Agency Program Directives, General Or Multidiscipline, Policy And Procedures For Requesting Records In Advance Of Or In Lieu Of A Drug Inspection, Staff Manual Guide 9004.1, 6. FDA, Inspection Records Request Form 4003. PT

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