Outsourcing gxp audits – mindful execution is key to success – validant yoga gas relief pose


Pharmaceutical and device firms outsource a variety of activities. Virtual firms outsource almost all GxP activities including the manufacture of API/drug substance, intermediates, final dosage forms, device components, and finished devices, as well as product design and development, labeling, packaging, and distribution. Another key activity many firms consider for outsourcing is the internal/external audit function. gas zone edenvale Whatever activities are outsourced, it involves a lot more than just signing on the dotted line.

When a manufacturing activity is outsourced, the sponsor must confirm that the CMO operates within an effective Quality System and must provide ongoing oversight of the contracted organization to ensure compliance with CGMPs. 21CFR 200.10 states “ The Food and Drug Administration…regards extra­mural facilities as an extension of the manufacturer’s facility.” Further, The 2016 FDA guidance on Contract Manufacturing Arrangement for Drugs: Quality Agreements states that contract analytical laboratories must “ …employ adequate controls to ensure that data and test results are reliable and maintained in accordance with CGMP requirements. It is the owner’s responsibility to review this information from the contract facility to decide whether to approve or reject product for release and distribution.” It is reasonable to assume that this requirement should extend to areas other than the analytical laboratory. For medical devices, EN ISO13485 Section 7.4.1 clearly requires records to be maintained of “ the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities”.

Some firms outsource audit activities for non-critical raw material suppliers while others may choose to outsource conduct of all GxP audits. An audit program may include evaluations of clinical trial operations, pre-clinical animal studies, hardware and software design and development for medical devices, both drug and device CMOs and component suppliers, or any number of additional GxP activities. gas jobs crna While outsourcing some or all of a GxP audit program provides many advantages, a firm should also recognize potential pitfalls based on accountabilities specified in the GxP regulations and relevant standards.

• Providing access to a large pool of skilled auditors, as a consulting firm can match the specific project needs with a person highly skilled in given subject matter areas across the GxP spectrum. Access to additional skilled auditors helps to combat pressing business priorities and can help to ensure that the audits are conducted in a timely manner.

• Providing auditors with specific in-depth expertise in areas where a sponsor may not have that expertise in-house. electricity trading jobs For example, device expertise is necessary when evaluating combination product operations, but drug companies often have limited resources in this area. Hiring consultants to serve as auditors, or to support internal auditors, can provide additional expertise and mentorship for the team.

• Do your due diligence. Can the consulting firm consistently provide qualified staff to conduct audits and provide appropriate written audit reports? Sponsors must ensure that the auditors are qualified. v gashi 2013 Qualification does not simply mean that they have certifications or initials behind their names. True qualification means that consultants have working experience in the area they are evaluating, understand the regulations and standards, and have expertise in auditing and writing reports. m gastrocnemius Often this step can be overlooked, and the sponsor fails to confirm that the consulting firm provides staff who have the necessary education, training, and experience, as specified in 21 CFR 211.25(a) and EN ISO13485 Section 6.2, to perform their functions. Remember, the auditors are functioning as an extension of the sponsor’s firm. Would you ever want to use an auditor to evaluate your parenteral CMO who has expertise exclusively in the chemical synthesis of APIs? Be sure to always request documentation that supports the competence and expertise of the auditor(s).

• Ensure that you partner effectively with the consulting firm. Outsourcing should not be a one-way street. Have you been open and honest with the firm, and do they listen to your concerns and address specific areas you, the sponsor, want to be covered during an audit? Always try to work together to set the audit agenda, finalize the report, and identify areas of concern.

• Evaluate how the audits are conducted and be wary of any firm that places heavy emphasis on ‘’ Checklists are great as reminders, but excessive reliance on checklists should raise a warning flag for sponsors. Documenting that a CMO/supplier has an SOP in place for investigation of deviations does not evaluate the completeness or adequacy of the SOP. Simple YES/NO responses add little or no value here.

Contracting with a consultant to supplement or be fully responsible for the conduct of GxP audits is an effective way to manage costs and leverage resources. gas mileage comparison A successful effort requires that the sponsor and consulting firm are true partners in this effort and communicate clearly and frequently regarding expectations. The sponsor should provide routine oversight of audit activities, as they would with any outsourced GxP activity. When executed well, a consultant and sponsor work together to ensure the sponsor’s needs are adequately represented, and the contracted activities represent the standards consistent with their Quality System.