Quality Metrics – FDA’s initiative towards a better Quality Management System (QMS).

Quality Metrics is an initiative to assess the effectiveness of the quality system of a firm. FDA’s guidance on quality metrics requests firms to provide data for an establishment manufacturing an API or finished formulation which would help them to understand the robustness of the process, laboratory operations and quality complaints.

The main goal of the FDA in implementing quality metrics is to measure the quality of a site and its systems. This will allow them to do a risk-based evaluation and better management of site inspections. FDA would work more closely and transparently with firms to ensure compliance of any site. They strongly believe that quality metrics will play an important role to achieve their vision of the desired state of quality in the 21^st century. It will also help to manage supply disruptions and drug shortage issues.

FDA draft guidelines published in Nov 2016 gives information concerning data submission and reporting of quality data. The initial phase is a voluntary program wherein the pharmaceutical firms will share data or observations gathered from their self-inspections. The FDA does not intend to take any enforcement action based on the data submitted by Industry provided the data is submitted in good faith. There are a lot of benefits of participating in this program, with the FDA working with sites informally for early resolution of their potential quality problems.

Most firms currently have some or other forms of quality metrics to continuously monitor the effectiveness of their quality system. The current process includes – annual product reviews (APR) or periodic product reviews (PPR), trend analysis, process validations and verifications, periodic inspections of the site and the systems. FDA recommends firms to go a step further and include more parameters such as compare metrics of different products manufactured at the same site, compare metrics of same product manufactured at different site and, the trend of data from a facility or site over sometime. These can be assessed by simple calculations such as :-

1) Lot acceptance rate

2) Invalidated out of specification (OOS) rate and

3) Product quality complaint rate

Another critical aspect is understanding the effectiveness of a firm’s Corrective and Preventive Action (CAPA). A CAPA is an important tool which helps to understand how well a firm can complete the root cause analysis of any quality problem and what measures are taken by the firm to ensure continuous improvement of the quality systems.

FDA suggested metrics will be extremely useful in having a common standard of measurement while there is a flexibility to measure additional indicators as deemed necessary by the firms to maintain their quality culture.

FDA data proves that adopting quality management programs early on has obvious advantages for firms such as operational excellence and high-quality culture which ultimately leads to good business and less surveillance by the FDA for high performing firms.

FDA intends to make this requirement mandatory after the voluntary phase is over as it will encourage the implementation of innovative quality management systems while helping the FDA to develop its compliance and inspection policies. It will surely help to resolve the issues of drug shortages which occurs predominantly due to either quality or manufacturing problems.

In June 2018, FDA announced two more voluntary programs, viz. quality metrics feedback program and quality metrics site visit program and posted frequently asked questions regarding both these programs.

The obvious question is will FDA’s vision turn into reality, and will the industry shift its focus on the use of science and risk-based principles rather than focussing on their current approach which is based on compliance of minimum requirements while managing the quality system. Looking at the way things are progressing through industry participation in voluntary programs and exchange of information between FDA and industry through pilot and feedback programs, there is a high probability that quality metrics are adopted as key indicators and will be implemented soon by the pharmaceutical industry.

My next blog onwards I will be sharing information on drug registration procedures and I will begin with sharing information about TGA’s (Australia’s) regulatory framework. See you soon!!