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Search Intensifies for Options to Resource-Draining Redundancies of Multiple Agency Inspections

May 2nd, 2013

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A roadmap of previous regulatory inspections and their results is among the ideas being voiced by industry that could help avoid resource-draining inspection redundancy by different agencies and rationalize GMP regulation internationally.

Documentation detailing areas at a plant that passed inspection could be prepared by agency investigators to allow others visiting subsequently to better target their efforts at the same facility, industry experts maintain.

While the issue of redundant inspections has been a recurrent concern expressed by industry for some time, the entry of additional regulatory agencies onto the international inspection stage as well as the growing complexity of manufacturing arrangements globally has heightened the concern.

There is an increasing effort by companies, associations and agencies to understand what the international inspection situation actually looks like and to find new ways of creating a more efficient, effective and risk-based inspection system.  Industry’s concerns are matched by regulators who, likewise, are struggling with how to pit their limited resources against the global oversight challenges.

The effort encompasses the harmonization of GMP and GDP standards based on the advancing quality regulatory paradigm and of the inspection procedures reflecting those standards – facets that the interagency Pharmaceutical Inspection Cooperation Scheme (PIC/S) is heavily involved in advancing.

A better system for communicating the inspection results, paving the way to mutual reliance on them and international inspection rationalization, is under development (IPQ “The News in Depth” January 4, 2012).

Helping drive the dialogue forward was a workshop on “GMP Inspection Practices and Trends” sponsored by PIC/S and PDA-Europe in Geneva in mid-2012.  The dialogue on international inspection trends and the potential for further harmonization and rationalization continued at the PDA/EMA meeting in Cascais, Portugal in December.

The PIC/S workshop attendance was divided equally between industry personnel and agency inspectors.  It included plenary presentations by regulators from Singapore and the Netherlands discussing recent inspection findings and an industry official addressing inspection redundancies and their impact.

Six breakout sessions followed on challenging issues raised during inspections and what an internationally acceptable resolution could look like regarding: ● pharmaceutical quality management systems ● root cause analysis, recalls and corrective and preventive actions (CAPAs) ● manufacturing and batch release documentation ● sterility assurance and sterile manufacturing technology ● design and maintenance of facilities and equipment, and ● personnel training.

Summaries of the breakouts were presented at their conclusion, followed by another plenary session that discussed international inspection collaboration providing both industry and agency perspectives.  The concluding session provided an opportunity for industry and regulators on the planning committee to give some closing remarks based on the workshop discussions.

PIC/S and PDA, along with ISPE, previously co-sponsored a workshop in late 2008 on the newly-revised Annex 1 on aseptic processing, also held in Geneva (IPQ “Special Report” Jan./Feb. 2009).

Industry expressed concerns at the Annex 1 workshop that some of the changes were prescriptive, based on worst-case regulator experience, and that the rewrite did not adequately take into account the science and risk-based quality regulatory paradigm that industry has been adopting.

[The story continues for subscribers beginning on page 2.  Included is an analysis of inspection redundancies at the PIC/S workshop based on the experience of a key Boehringer Ingelheim facility in Germany, an industry-wide view of inspection trends, and a discussion among industry leaders of the areas specific agencies have been focusing on.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ stories:

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Revamped EudraGMP Database May Make GMP Noncompliance Statements Public

FDA and EMA Formalize Mutual Inspection Reliance Program

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

International Joint API Inspection Pilot Program Sees Positive Results

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