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Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
Q: We are a medium-sized company in Europe, specializing in gene-therapy products. So far, we have only marketed our products in Europe, but we are planning a global expansion. By now, we are familiar with the European inspectors and how they inspect. How can we prepare for inspections from overseas agencies? We hear that there is no harmonization in expectations?
A: Congratulations on your plans and being proactive in preparing for these inspections. To some degree, inspectorates from around the world are making attempts at harmonizing how they inspect. Regulatory agencies that belong to Pharmaceutical Inspection Co-operation Scheme (PIC/S) follow a harmonized inspection process. It is sensible to familiarize oneself with these procedures, which are freely available on the PIC/S website (1).
Other drivers for harmonization are mutual recognition agreements (MRAs), which require agencies to recognize each other’s competence and equivalence. Currently, the United States and the European Union (EU) are in the process of finalizing such an MRA (2). As you will already be aware, inspectorates of the EU’s member states, the National Competent Authorities, are all peers (i.e., recognizing each other’s inspections as completely equivalent) (3).
That said, you may still encounter differences in inspection process and style, and moreover, differences in opinion from your inspectors. Why might this be? There are three main contributions:
To make your inspections as smooth and successful as possible, you need to acquaint yourself with all three aspects and prepare for them. A pharmaceutical firm is legally required to comply with the national regulations in any country it wishes to market its products. Therefore, you must be familiar with the regulations. For example, your products will have to comply not merely with the pharmacopeia in your native country, but also with those of the country the overseas inspector is from. Do not be surprised if an inspector wants to see that you do possess a copy of that document and that you can read it if it isn’t in your native language.
Many agencies publish details on how they inspect and often also provide additional information on the inspection process and the agency’s expectations. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), for example, has a blog (4). FDA publishes guidance for industry documents (5), and Australia’s Therapeutic Goods Administration (TGA) updates information on their inspection approaches regularly on their website (6). It is essential to stay informed on the inspection process, as some agencies may have specific requirements. Russia’s Roszdravnadzor, for example, requires you to provide certified third-party translators with good manufacturing practice expertise for its inspection; or Colombia’s National Food and Drug Surveillance Institute (INVIMA) expects you to have all observations resolved by end of inspection. Here, the difficult part is that not all the expectations are included in the guidance documents. The best way to get access to such detailed information is to use the help of professional service providers and to interact with peers (e.g., at conferences or through industry associations).
The last point, namely an inspector’s personal opinions, is one you simply have to address at the time of the inspection. As with all inspections, courtesy and professionalism will go a long way.
To answer your question: be prepared by having a sound understanding of the regulations and the regulatory inspection processes, including the unwritten expectations. Regulatory intelligence is essential as regulations change continuously and so do the inspection processes.
1. PIC/S, www.picscheme.org.
2. EC, Public Health blog.
3. S. Mylona and E. Donovan, “Module 09–Good Practice and Inspections,” Presentation at the 2nd International Awareness Session–The EU Medicines Regulatory System and the European Medicines Agency, March 8–9, 2018,.
4. MHRA, MHRA Inspectorate Blog, mhrainspectorate.blog.gov.uk.
5. FDA, Compliance Program Guidance Manual, www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm.
6. TGA, Manufacturing Inspections, www.tga.gov.au/manufacturing-inspections.
Volume 32, No. 1
Pages 50, 49
When referring to this article, please cite it as S. Schmitt, "Global Inspection Harmonization," BioPharm International 32 (1) 2019.