US FDA has now issued draft guidance on Quality Metrics and expects industry comments before January 2017 end.
Quality metrics data is used in both pharma and biologics industry to monitor quality control systems to drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA. It would to help develop compliance, inspection policies and practices like risk-based inspection scheduling of drug manufacturers. The move according to the regulatory authority would improve its ability to predict and possibly mitigate, future drug shortages.
It would encourage the pharmaceutical industry to implement advanced, quality management systems in manufacturing. The regulator indicated that the revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.
In order to achieve this, the regulator is initiating a voluntary reporting phase of the quality metrics reporting programme. The objective is to learn more about a limited set of quality metrics and associated analytics.
During the voluntary phase of the reporting program, FDA will accept voluntarily submissions of data from drug establishments. It expects that the large majority of voluntary reports will be submitted by establishments engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms of ‘covered drug products’ or active pharmaceutical ingredients (APIs).
The voluntary reporting phase is not focused on reporting from certain CDER regulated manufacturers. These are those companies operating under section 503A or registered as outsourcing facilities under section 503B of the FD&C Act or CBER regulated manufacturers of blood and blood components for transfusion, vaccines, in vitro diagnostics, cell therapy products, gene therapy products, allergenic extracts, human cells, tissues, and cellular and tissue based products.
In the area of modernization of regulatory oversight of drug quality and promotion of post-approval improvements, the regulator hopes to mitigate drug shortages by addressing the underlying causes of shortages. This according to the regulator would encourage the implementation of a modern, risk-based pharmaceutical quality assessment.
The industry involved in the manufacture, preparation, propagation, processing of human drugs, currently use quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.
Now the regulatory authority intends to ensure that the companies will need to provide consistency in reporting to assess the overall effectiveness of a PQS, within reasonable limits, and in a reasonable manner, while avoiding any undue burden.
The regulatory authority is of the view that these quality metrics data, in conjunction with other data submitted during the global audits will provide important information about operational reliability.
Industry experts consider this guidance to be important in the current situation of surprise inspections by international drug regulators and the demand to remain constantly compliant.