We are empowered to do what’s right for our patients, the GI community and Ironwoodians. But we do so while upholding the highest standards of safety, ethics and compliance.
Elements of the Ironwood Pharmaceutical Quality System (PQS)
Our Audit Committee, through its quarterly compliance updates, and our Board of Directors have ultimate accountability for Quality issues.
Our Chief Operating Officer, who reports directly to the CEO, has accountability to maintain the performance of the PQS. The PQS is supported by a senior level management representative (Head of Quality) who has independent oversight and responsibility for all Quality matters. The Head of Quality is responsible for reporting to Executive Management on any Quality events that have the potential to impact product quality and safety.
Ironwood’s GxP employees (including internal GxP contractors), individually and collectively, are responsible for operating within the guidelines of the PQS in all relevant parts of the organization.
Periodic, risk-based internal audits are carried out to ensure that our procedures are current and suitable for their intended use, and the internal policies and procedures are being executed as written. Audit results and any corrective actions (CAPA) are communicated to functional area management and the Head of Quality.
Ironwood hires personnel who are qualified by training, education, and experience to perform their duties. The GxP Training program ensures that basic training requirements are established for all GxP employees and are intended to ensure that GxP employees are properly trained and capable of performing all required job duties in compliance with applicable laws, rules, regulations, Ironwood policies and procedures, and industry best practices.
Ironwood’s QRM program includes risk assessments and mitigation elements of all GxP activities, including those risks to computerized systems.
Ironwood cross-functional technical teams assess the technical capabilities, and Quality qualifies each GxP vendor. Ironwood Quality conducts routine audits to verify compliance, quality, and adequate vendor oversight by Ironwood functional areas.
Although Ironwood does not directly perform GMP manufacturing and testing on site, several procedures have been established within the Ironwood PQS to:
- Outline the processes for ensuring GMP activities carried out at Ironwood GMP Vendors meet regulatory requirements, industry best practices and internal Ironwood standards, and,
- Detail the GMP requirements of an Investigational New Drug (IND) sponsor or Marketing Application Holder (MAH) and describe how these requirements are met.
For outsourced GMP activities, Quality Agreements are established to ensure patient safety, product quality, continuous drug supply and data integrity, primarily through Vendor and manufacturing oversight. Ironwood Quality retains responsibility for disposition of finished drug products unless this responsibility has been delegated to a vendor in a Quality Agreement.
Inputs from process performance and product quality monitoring, deviations, product rejections, investigational product complaints, internal and external audits, and regulatory inspections are evaluated for level of risk, and are assessed and trended to determine the necessity of corrective and/or preventive actions. The CAPA approach is intended not only to correct or prevent recurrence or occurrence of an issue, but also to result in improvements in Ironwood product, processes, and Quality systems.
Commercialization
A process is defined for commercial product labeling development, review, and approval. Quality Operations is responsible for approving product labeling and oversight of the development, review, and approval process. Responsibility for compliance oversight of marketing, promotions and advertising lies with the Corporate Compliance function, including establishing and documenting procedures for marketing activities which comply with applicable law, regional requirements, and training qualified personnel on those procedures.
Ironwood applies the same quality principles to drug distribution and returns as it does to other manufacturing activities. The key quality activities include Third Party Logistics (3PL) provider qualification, and subsequent ongoing oversight. Drug distribution processes, policies and procedures are established that are designed to meet applicable laws, rules, regulations and product pedigree requirements for product returns and reporting.
Critical, key and selected non-critical process parameters, material attributes, critical in-process controls, and critical quality attributes are continuously monitored, trended, and analyzed during commercial manufacture to assure product quality and that the process remains in a state of control. Process performance and product quality monitoring information is captured in product reviews that are generated on a routine basis.
Product Complaint, Field Alert and Recall processes are established to ensure product quality and patient safety during marketing of commercial products. In instances when a Field Alert (FAR) or Product Recall action is required for a distributed, commercial product(s) for which Ironwood holds the regulatory responsibility (i.e., Marketing Authorization Holder). Quality is responsible for initiating Ironwood’s process and monitoring progress, ensuring that all planned actions have been completed and communicated to applicable health authorities in a timely manner.
Our Strong Oversight
Cybersecurity
We implement a multilayered cybersecurity program designed to maintain the confidentiality and integrity of our data and systems and to protect our users from potential breaches. The program is overseen at multiple levels within our organization, including by our Audit Committee and Board of Directors and is reviewed annually by our Audit Committee with updates to our Board.
All employees are required to take monthly, quarterly and annual cybersecurity training and participate in quarterly Phishing test campaigns. In addition, we have a comprehensive business continuity plan in place designed to ensure restored access to critical systems in the event of a disruption to our infrastructure.
Ethics and Compliance
At Ironwood, compliance starts with, and is the responsibility and continuing obligation of, each Ironwood employee, officer, director, contractor or other third parties acting on behalf of Ironwood (Ironwood Representatives). We rely upon and expect that Ironwood Representatives will conduct themselves in compliance with Ironwood policies, and applicable laws, rules, and regulations. For more information, please see our Compliance Plan.
