CMO
While the pharma operational personnel can be satisfied that the CRO/CMO can provide the requested process/service/product, QA need to be
satisfied that such process is validated, that adequate quality control steps have been incorporated,
monitored for effectiveness, and see that the actual testing, deviation, and complaints’ management data, etc, demonstrate the process effectively.
Risk-based regular post-contract audits are a good practice and expected by the regulatory authorities. Generally, most people find that being audited is not the most pleasurable experience, but the benefits are substantial, considering that an audit:
• Affords a better understanding of a customer’s different needs
• Helps to demonstrate the good capabilities of a CRO/CMO to a selecting sponsor
• Identifies gaps/non-conformities before they are identified during regulatory inspections (and not on a Form 483). Even if the audit outcome results in losing a client, with proper CAPA, it can protect against losing every client!
• Clear quality commitments through specific and transparent QA and quality control elements because technical details are not the only prerequisite for contract arrangements
• Contractually stated assurance that when the provider subcontracts to a third party, the level of control and quality will not be compromised
· A stringent vendor selection process with Pharma company approval
Establishing a robust contract is more than a financial document. It pays dividends to have training and experience on how to make and sustain a good agreement.
Establishing a Successful Oversight System for
the Partner Oversight of contracted providers of GxP-regulated services and products is a regulatory requirement.6
The more a company
outsources a GxP-regulated task, the more oversight is expected.
Various international quality standards require that the quality system responsibilities extend to the oversight and review of outsourced activities. The contract giver should be responsible for assessing the suitability and competence of the contract acceptor,9
and the
control of such outsourced processes shall be identified within the QMS.10
While the legislations could be more explicit in stating the requirement for oversight, they do execute explicit penalties when this requirement is not fulfilled. A simple review of a few warning letters on the FDA portal demonstrate this: “…failure to clearly define the type and extent of control to be exercised over suppliers,”11
“…while Company X supplier
approval procedure provides for ongoing monitoring, it ‘does not define the frequency & type of monitoring for these suppliers.11
”
The term “supplier oversight” is almost always associated with diligent audits, which are indeed imperative.9
However, systematic, risk-
based vendor monitoring is more effective in the long term.9
Sponsors must understand
what may adversely impact their process/ product and deign the oversight system and its tools accordingly. Oversight tools include scorecards, key performance indicators, and both quality metrics and performance metrics—otherwise this may send the wrong message that performance is more important than quality. QA support in establishing the quality metrics is, therefore, paramount. Metrics can be useful and objective measuring tools to generate feedback to discuss with teams and solve problems.
Vendor oversight supports Quality by Design, as oversight is established to ensure quality and compliance (among other things). Vendor oversight should be an integrated part of the life cycle of the partnership. Indeed, this ensures awareness of the process earlier rather than later where it may be interpreted as a sign of decreasing confidence.
Pharmaceutical Outsourcing | 20 | March/April 2015
• As CROs/CMOs are subject to regulatory inspections, the impact of the issues being identified during a client audit is lower compared to the impact of issues identified during a regulatory inspection. This reduces the chance of unexpected surprises at regulatory inspections for both parties
• Helps preparation/grounding for hosting future regulatory authority inspections (if they have not been inspected before), and streamlines processes and communication
• Can measure promptness in problem resolution and cooperation
• Provides additional resources to the provider’s own internal QA resources and an external view
• Provides a sense of assurance for the pharma company, and a knowledge of quality status over time
Key Takeaways
• A company can delegate GxP-regulated tasks but not the legal responsibility
• Selection needs to be an objective, inclusive, and balanced process using multiple criteria and a risk-based approach
• Pharma needs to drive a shift from tactical to strategic partnerships
• Pharma needs to take into consideration if the selection is for a one-time relationship or for a long-term partnership
• Oversight and governance of the relationship/partnership should be integrated at the inception of the partnership
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