A key activity in optimizing product quality is critically assessing your quality systems against proven quality maturity models – such as those described in Quality is Free, by Phillip Crosby. We took Crosby’s quality management model and enhanced it based on our experience in the life sciences industry. Using this model, our initial focus was on how organizations can ensure product quality by optimizing the performance of their quality systems.
In revisiting the Quality Maturity Model, our focus is shifting to a key challenge facing pharmaceutical, biotechnology, and medical device manufacturers today – achieving quality in a global market that is constantly under the scrutiny of various regulatory agencies.
In an attempt to eliminate these regulatory hurdles, a network of scientific organizations launched a global initiative to harmonize regulations and legislation. The objective is to encourage convergence among regulatory systems at the global level, facilitating trade while preserving the right of participating members to address the protection of public health using regulatory means considered suitable for their nation. In theory, this will result in a reduction of regulatory differences in submissions/approvals, audits and enforcement.
In order to achieve global harmonization, companies and regulatory authorities need to receive and react to information consistently, something that in the past has proven difficult. So the big question is: how does your company maintain a mature quality system that is still flexible and adaptable enough to meet multiple market needs and regulatory standards?
Quality is a measure of a product’s ability to satisfy the patient’s stated or implied needs. Quality systems are a company’s formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product quality requirements, customer satisfaction, and continual quality improvement. A mature quality system has quality, safety, and effectiveness designed into the system and built into the product. Quality is not tested into the finished product, nor is the product tested into compliance in a mature quality system. Each step in the process is controlled to maximize the probability that your product meets all pre-established quality and design specification limits. A mature quality system is designed to assure overall compliance with cGxPs, internal procedures, and specifications.
For more, please download our report.