ISPE, in cooperation with McKinsey and Company and 21 participating companies, designed and undertook an extensive Pilot Program from 2014 – 2016 to test the feasibility of collecting and reporting a standardized set of quality metrics. The ISPE Quality Metrics Wave 2 Report provides a further understanding of the relationships first reported in the ISPE Quality Metrics Pilot Wave 1 Report. Learn more about the information reviewed and reported in the Quality Metrics Wave 2 Report.
ISPE submitted comments to the FDA on the Draft Guidance on Quality Metrics. Comments focused on the data-driven research obtained through its Quality Metrics Pilot Program Wave 1 and 2. In addition, ISPE was a highly active participate in a Cross Industry Quality Metrics Collaboration Group which provided consolidated group comments to the FDA. Read about the comments submitted by ISPE and the Collaboration Group to the FDA on the draft guidance on Quality Metrics.
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), announced the availability of a draft guidance for industry entitled Request for Quality Metrics for Industry.
According to the Federal Register Notice, "The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations."
At the plenary session of the very successful ISPE/FDA/PQRI Quality Manufacturing Conference held in Washington, DC from 1–3 June 2015, ISPE announced that it will continue its important Quality Metrics Initiative with a Pilot, Wave 2.
The new ISPE Quality Metrics Initiative Pilot Program–Wave 1 Report contains critical learnings on quality metrics using real data provided by 44 sites from 18 companies – a first for the pharmaceutical industry.
The Quality Metrics Summit brought together industry experts for a dynamic discussion on the importanct of quality metrics to supply chain operation excellence. Attendees were able to provide input to the FDA on the proposed metrics through direct dialog.
Janet Woodcock, MD, Director, center for Drug Evaulation and Research, FDA/CDER/OCD, asked
“How do we get to a better place where quality is not equated with a lot of inspections? How do we decrease inspections? We can reduce them by having a standardized and robust system of quantitative measures that we can trust. I don’t want quality metrics to increase the fear factor.”
Summit attendees learned directly from the ISPE Quality Metrics Task Team on the results of the pilot program and received an advanced copy of the ISPE Quality Metrics Pilot Program report.
Pilot Program: Wave 1 Recruitment Update
ISPE is pleased to share that there are now 18 companies and 44 sites with confirmed participation in Wave 1 of the Quality Metrics Pilot Program. The companies participating in the pilot are representative of generic, innovator, over-the-counter and contract manufacturing organizations and a variety of manufacturing technologies that include for example, solid dosage forms, sterile drug products, active pharmaceutical ingredients and analytical testing laboratories spanning both small and large molecule platforms. The objective of Wave 1 of the pilot is to provide real world experience with metrics definitions, data collection and reporting burden for the benefit of both industry and regulators.
Wave 1: Detailed Metrics Definitions
Following detailed evaluation of the various industry and regulatory considerations related to proposed pharmaceutical quality metrics, the ISPE pilot metric set was developed to include 14 measures reflecting a mix of leading and lagging indicators collected by site and product. Twelve (12) of the metrics collect quantitative data responses and two (2) of the metrics (for Process Capability and Quality Culture) collect qualitative data responses using a survey based format.
ISPE announced that its Quality Metrics Pilot Program has achieved a major milestone by recruiting 11 companies with 31 sites representing generic, innovator, over-the-counter and contract manufacturing businesses.
The list of quantitative metrics measures site, product and quality system performance and has been designed to be a blend of leading indicators and lagging indicators.
The program to demonstrate the feasibility and value of standard Quality Metrics is officially underway and now open to any drug manufacturing company that is registered with FDA.
ISPE will conduct the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the FDA. The pilot will refine the proposed set of metrics and definitions, data submission process, and evaluation.
At the invitation of FDA, the ISPE Quality Metrics working group developed a whitepaper on potential measures of product quality, site operations quality and site systems performance. The recommendations contained in the paper stem from robust industry - FDA discussions facilitated by ISPE’s Quality Metrics working group.
The ISPE Quality Metrics working group released a status report detailing an initial list of quality metrics considered acceptable to industry as a starting point. These metrics would be reportable to FDA to support a risk-based inspection program as called for in sections 704 to 706 of FDASIA, and should assist industry in moving towards the 'desired state.'
Robust industry/regulator conversations continued as the ISPE Quality Metrics Task Teams presented their initial recommendations for comment and input at two capacity-attendance sessions at the ISPE Annual Meeting in Washington, D.C.
The industry’s first public industry-regulator dialog was held at the 2nd Annual ISPE-FDA CGMP Conference, Baltimore, Maryland, USA. Task Teams were formed to continue working in the areas of Out of Specification/Laboratory Failure Investigation Rates, Batch Failure Rates, and Leading Metrics/New Ideas.
Please send any feedback to PQLI@ispe.org.
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