Global Change Protocols Proposed as Part of a More Standards-Based Approach to Regulating Life Cycle Management Internationally

Globally standardized change management protocols that would clarify the expectations internationally for implementing various types of manufacturing changes is among the proposals that are now on the table as industry and regulators explore what a more scientifically-based, efficient and harmonized quality regulatory paradigm could look like.

The global change/comparability protocol (GCP) concept is being advocated in the international lifecycle management discussions in the wake of the positive experience companies have had in the US with the use of protocols for making the same changes to multiple products.  

The standardization of these CPs and their adoption broadly across regulatory agencies would help reduce the complexity that is causing major problems for the pharmaceutical industry, the advocates are proposing, pointing to a similar standards-oriented approach that is taken in the medical device arena globally as a model.

The GCP idea is among those that have been receiving the attention of a team PDA has set up on post approval change (PAC) issues and was vetted by team members at a PDA workshop at the end of September focused on exploring the current regulatory problems and potential solutions in the PAC arena. [See IPQ December 1, 2015 for a fuller description of the workshop.]

After taking a hard look at the problems firms currently face globally in trying to make manufacturing changes (ibid.), the workshop participants explored where solutions may lie and what a different regulatory paradigm could look like.

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