We know how tough the business environment is right now and in an attempt to help the pharma industry in these uncertain and fast moving times, NSF experts asked themselves these questions: When you can’t fulfil the need to perform GMP inspections due to travel restrictions, what are your options? What can you do to keep your pharmaceutical supply chains in operation or your clinical trial materials available?
We have developed and trialed a four-step approach to allow for remote and virtual GMP auditing which helps you to unlock supply chains and meet cGMP needs in technology transfer, clinical trial supply or routine operation.
This risk-based approach will help to provide interim or conditional approval of facilities and quality systems during periods of uncertainty or governmental restrictions.
Using our network of international GMP experts, e-rooms and videoconferencing, NSF can offer a hybrid approach to auditing that is justifiable, insightful and timely:
Step 1: Risk assessment of the operation, assessing how insightful a remote or virtual audit could be, enabling interim approval of your supplier, CMO or partner. Our toolkit is offered free of charge.
Step 2: Remote review of the pharma quality system by expert evaluation of the supplier’s key policies and procedures vs. internationally recognized quality and cGMP expectations. This step is offered as one day of support for all non-sterile formulations or APIs or as two days for sterile/biotech or biological products.
Step 3: Remote review and videoconferencing session to evaluate the evidence of implementation of the key policies and procedures in place. Steps 2 and 3 are aimed to allow for a justifiable interim approval where warranted. This step is offered as one day of support for all non-sterile formulations or APIs or as two days for sterile/biotech or biological products.
After steps 2 and 3, we prepare a detailed written report of findings and recommendations for client scrutiny within 10 working days (1.5 days of support required). If requested, when a detailed GMP remediation or CAPA plan is prepared by the client or partner, NSF will then offer a detailed technical edit of the plan, ensuring a full range of corrections, corrective actions and preventive actions is defined for each observation, along with effectiveness checks and follow-ups. This review is designed to ensure your finite high-value resources are only applied to tasks that will measurably reduce the risk or severity of recurrence of each specific observation/non-conformance. We will help you to ensure your remediation plans are proportionate, aligned to cGMP and sustainable, and that they deliver an effective action aligned to the organizational behaviors you need to see in place. The CAPA and remediation plan review is offered free of charge.
Step 4: Delivery of an on-site GMP audit on a suitable/appropriate date, performing observation, on-site evaluation and auditing to complete the formal GMP assessment. This can be an abbreviated review, given the comprehensive nature of steps 2 and 3.
We know it’s tough, but in uncertain times our reputation as solution providers is clearly more valuable than ever. Please get in touch at firstname.lastname@example.org and let us help you find the best-fit options that keep global health care a priority for all.
Watch our short webinar from expert Dave Waddington who explains the service in more detail.
Did you know we also have local GMP experts in most European countries who, subject to approval from the host, can perform your GMP audit obligations without international travel? We keep a network of local experts to serve your specific country requirements, keeping within any national restrictions or guidance.