- Pharmaceutical industry recognizes that Good Manufacturing Practice (GMP) inspections are one of the fundamental ways by which a regulatory authority can ensure that medicinal products are being manufactured to high quality standard and compliant with GMP regulations.
- Globalization and outsourcing extended the sources of manufacturing of medicinal product and active pharmaceutical ingredient (API). Over the past decade, there has been an increase in the number of GMP inspections at the same manufacturing site while some other sites were not covered by inspections. This situation raised the need to improve the use of resources.
- Industry supports a collaborative global approach (e.g. and mutual acceptance) using risk-based management tools for regulatory inspections to address the challenges of globalisation.
- An appropriate level of regulatory oversight through continued international cooperation can facilitate the best use of regulator and industry resources to better control overall risks which ultimately can only be a benefit for patients.
Inspections are part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture of specific pharmaceutical products, usually in relation to an application for marketing authorization. A further aspect of pharmaceutical inspection is monitoring the quality of pharmaceutical products in distribution channels, from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of counterfeit medicines.
The globalization of the pharmaceutical industry in terms of product development,, global manufacturing, and global sales has led to increasing demands on regulatory agencies to ensure the safety and effectiveness of drugs marketed in their country. Recent surveys conducted by EFPIA, JPMA and PhRMA as well as figures published by regulators (including US FDA, EMA, Japan PMDA) reported an increasing number of Pre-Approval Inspections (PAIs) and GMP inspections by foreign regulatory agencies. Similar focus of inspections resulted in similar observations by different regulatory authorities inspecting the same site.
No agency in the world has the resources to inspect all drug manufacturing establishments. To meet the challenge of safeguarding a nation’s drug supply in today’s global market place, there is a need for rationalization of the number of inspections.
Inspection programs should be driven to inspect those global establishments that are identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment. Inspection scheduling could be even more risk-based, providing broader coverage with cooperative arrangements among competent regulatory authorities. Quality Risk Management established by ICH Q9 applies both to industry and regulators. For inspection, key factors need to be included to establish the Quality risk-based approach as those linked to the product (e.g. aseptic, toxic and paediatric) as well as the inspection history of the site and the company.
Industry fully supports the strengthening of international collaboration in GMP inspections with the view to develop a regulatory inspection framework approach at a global level (e.g. Mutual Recognition Agreements (MRA) between national/regional authorities; confidentiality agreements for sharing inspection reports; joint GMP inspections; acceptance of GMP-certificates based on legal formats (e.g. WHO Certificate of Pharmaceutical Product (CPP) ); and recognition offor GMP (e.g WHO, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), ICH Q7, Q9 and Q10).
Industry considers optimisation of the inspection approach needs to be associated with capacity building of regulatory authorities in term of assessment and inspection with initiatives such as the WHO prequalification program contributing significantly., PIC/S, and the
The final responsibility of quality products stays with the manufacturer and its ability to manage the supply chain under its control.
An inspection undertaken by a regulatory body at a company manufacturing site within the regulatory body’s own country (domestic inspection) or outside of the regulatory body’s own country (foreign inspection)